Despite compelling evidence that patients and families report valid and unique safety information, particularly for children with medical complexity (CMC), hospitals typically do not proactively solicit patient or family concerns about patient safety. We sought to understand parent, staff, and hospital leader perspectives about family safety reporting in CMC to inform future interventions.
This qualitative study was conducted at 2 tertiary care children’s hospitals with dedicated inpatient complex care services. A research team conducted approximately 60-minute semistructured, individual interviews with English and Spanish-speaking parents of CMC, physicians, nurses, and hospital leaders. Audio-recorded interviews were translated, transcribed, and verified. Two researchers coded data inductively and deductively developed and iteratively refined the codebook with validation by a third researcher. Thematic analysis allowed for identification of emerging themes.
We interviewed 80 participants (34 parents, 19 nurses and allied health professionals, 11 physicians, and 16 hospital leaders). Four themes related to family safety reporting were identified: (1) unclear, nontransparent, and variable existing processes, (2) a continuum of staff and leadership buy-in, (3) a family decision-making calculus about whether to report, and (4) misaligned staff and parent priorities and expectations. We also identified potential strategies for engaging families and staff in family reporting.
Although parents were deemed experts about their children, buy-in about the value of family safety reporting among staff and leaders varied, staff and parent priorities and expectations were misaligned, and family decision-making around reporting was complex. Strategies to address these areas can inform design of family safety reporting interventions attuned to all stakeholder groups.
Families, especially families of children with medical complexity, frequently identify medical errors and adverse events in hospitals. However, formal processes to actively engage families in hospital safety reporting are limited.
Although clinicians recognized families’ expertise, family safety reporting processes were limited, perceived value of family reporting varied, family decision-making around reporting was complex, and staff and parent priorities and expectations were misaligned. We accordingly identified strategies for engaging families in safety reporting.
Children with medical complexity (CMC), children with multifaceted, difficult-to-manage clinical and functional needs,1 are vulnerable to medical errors.2 Their families are also adept at recognizing medical errors.3,4 Despite compelling data that patients and families report valid, complementary safety information,3–10 particularly for CMC,3,4 most hospitals have not operationalized patient and family reporting. Whereas best practices for family safety reporting do not exist, principles of family-centeredness call for patient and family collaboration in all aspects of care, including safety.11–15
Voluntary incident reporting (VIR),16 a key method hospitals use to evaluate safety, suffers from underreporting, capturing approximately 1% to 10% of all safety incidents.17–19 VIR includes staff but not patients and families. However, staff recognize and report less than 1 in 7 errors and harms detected through systematic surveillance.16 Thus, hospitals fail to comprehensively capture safety information, particularly from patients and families, presenting a barrier to reducing harm for CMC.
We aimed to explore family safety reporting in CMC. Our research question was: what are the parent, nurse, physician, and hospital leader family-safety-reporting-related experiences, perceptions, barriers, facilitators, and suggestions? We sought to understand these stakeholder perspectives to inform interventions to integrate families into hospital safety surveillance and, ultimately, reduce harm for CMC.
Methods
Study Design
We conducted this qualitative study from December of 2018 to July of 2021 at 2 tertiary children’s hospitals with complex care services. A physician, nurse, and researcher team conducted approximately 45 to 60-minute semistructured, individual in-person (or, during COVID-19, telephone and videoconference) interviews with English- and Spanish-speaking parents of hospitalized CMC as well as hospital staff and leaders. We audio-recorded, translated, transcribed, and verified interviews. Two researchers coded interviews using thematic analysis.20 They developed and iteratively refined a codebook with validation by a third researcher. We analyzed codes into emerging themes until we achieved thematic saturation.21 Boston Children’s Hospital’s institutional review board approved the study.
Settings
Both hospitals had dedicated complex care programs (Hospital A = ∼2000 patients; Hospital B = ∼40), family advisory councils, and patient relations departments (which liaise with patients and families and administrators to address patient and family concerns and requests). Hospital B had a large primarily Spanish-speaking population (∼40%); Hospital A had a smaller Spanish-speaking population (∼5%). Both hospitals embarked on high reliability organization journeys over 5 years ago and had robust VIR programs for over 15 years with regular staff training encouraging VIR. Neither hospital’s VIR directly solicited concerns from patients and families, though Hospital B had an infrequently used, little-known family reporting hotline.
Participants
English- and Spanish-speaking parents and caregivers (“parents” hereafter) of CMC hospitalized on pediatric units at both hospitals were eligible. We approached parents in-person or by telephone during or after hospitalization. Given disparities in family safety reporting by education,3,4 we purposively sampled parents by education. We also sampled parents by language and years part of complex care. We purposively sampled staff by level and position, interviewing bedside and charge nurses, nurse practitioners; hospital medicine and complex care attending physicians, residents, and fellows; allied health professionals (eg, social workers); and hospital leaders in safety and quality, legal, experience, patient relations, and medicine and nursing. Participants provided verbal consent facilitated by an information sheet.
Data Collection
We conducted in-depth individual interviews using a semistructured interview guide tailored to participant type and iteratively revised during analysis. Topics included family-safety-reporting-related experiences, facilitators, barriers, preferences, and suggestions. We professionally translated the parent interview guide into Spanish and a bilingual researcher verified it.
Interviewers took notes during interviews and completed memos afterward. Interviews were audio-recorded and professionally transcribed. Bilingual researchers (B.Q.P. and K.L.) conducted Spanish interviews, which a professional multilingual translation and transcription service transcribed and translated. We verified and deidentified transcripts before coding.
We collected participant demographic data via questionnaires completed before or after interviews. Demographics included age, gender, race and ethnicity, role, and parent income, education, and language.
Data Analysis
We conducted an inductive and deductive thematic analysis22,23 of transcript data to identify experiences, barriers, facilitators, and strategies relating to family safety reporting. A physician and nurse (A.K. and J.B.) trained in qualitative methods independently reviewed transcripts to inductively generate initial codes, meeting to compare initial codes and draft a preliminary codebook. They applied the codebook to data and met regularly to refine it, with validation by a third investigator. After refining the preliminary codebook, we developed a final codebook to apply to all transcripts. Each interview was double-coded, with 1 primary and 1 secondary coder. Coders met regularly to review transcripts and resolve coding discrepancies. Data collection and analysis occurred concurrently to allow iterative review of emergent themes, sample, and interview guide adjustment, and assessment of thematic saturation.22,23 We used Dedoose24 to facilitate coding, analysis, text search, and theme development. We evaluated themes across roles and organized them into a conceptual model (Fig 1).
Results
We interviewed 80 participants (34 parents, 19 nurses and allied health professionals, 11 physicians, and 16 hospital leaders) (Table 1). Interviews lasted approximately 45 to 60 minutes. Data analysis revealed 4 themes related to family safety reporting: (1) unclear, nontransparent and variable existing processes, (2) a continuum of staff and leadership buy-in, (3) a family decision-making calculus about whether to report, and (4) misaligned staff and parent priorities and expectations. We also identified participant-suggested strategies for engaging families and staff in family safety reporting (Table 2).
Characteristic . | . |
---|---|
Parent and Caregiver (n = 34) | |
Age, y, mean (SD) | 44 (11) |
Times patient admitted to hospital in past 12 mo, mean (SD) | 3 (4) |
Annual household income, n (%) | |
≤ $49 999 | 24 (71) |
≥ $50 000 | 8 (23) |
Unknown | 2 (6) |
Education, n (%) | |
Less than college | 23 (68) |
Completed college or higher | 11 (32) |
Gender, n (%) | |
Male | 5 (15) |
Female | 29 (85) |
Language interview conducted in, n (%) | |
English | 19 (56) |
Spanish | 15 (44) |
Language proficiency, n (%) | |
English proficient | 17 (50) |
Limited English proficiency | 16 (47) |
Unknown | 1 (3) |
Race and ethnicity, n (%)a | |
American Indian or Alaskan Native, non-Hispanic | 0 |
Asian or Pacific Islander, non-Hispanic | 1 (3) |
Black or African American, non-Hispanic | 1 (3) |
White, non-Hispanic | 12 (35) |
Other, non-Hispanic | 1 (3) |
No. of years part of complex care service | |
0–1 | 11 |
2–4 | 11 |
5–10 | 4 |
11 or more | 8 |
Hospital staff and leaders (n = 46) | |
Age, y, mean (SD) | 50 (12) |
Gender, n (%) | |
Male | 8 (17) |
Female | 38 (83) |
Race and ethnicity, n (%)a | |
American Indian or Alaskan Native, non-Hispanic | 0 |
Asian or Pacific Islander, non-Hispanic | 7 (15) |
Black or African American, non-Hispanic | 0 |
White, non-Hispanic | 31 (67) |
Other, non-Hispanic | 2 (4) |
Hispanic | 6 (13) |
Unknown | 2 (4) |
Role, n (%)a | |
Attending physician | 11 (24) |
Case manager | 2 (4) |
Fellow | 1(2) |
Hospital leader | 16 (35) |
Lawyer | 3 (6) |
Nurse | 16 (35) |
Resident physician | 2 (4) |
Social worker | 4 (9) |
Characteristic . | . |
---|---|
Parent and Caregiver (n = 34) | |
Age, y, mean (SD) | 44 (11) |
Times patient admitted to hospital in past 12 mo, mean (SD) | 3 (4) |
Annual household income, n (%) | |
≤ $49 999 | 24 (71) |
≥ $50 000 | 8 (23) |
Unknown | 2 (6) |
Education, n (%) | |
Less than college | 23 (68) |
Completed college or higher | 11 (32) |
Gender, n (%) | |
Male | 5 (15) |
Female | 29 (85) |
Language interview conducted in, n (%) | |
English | 19 (56) |
Spanish | 15 (44) |
Language proficiency, n (%) | |
English proficient | 17 (50) |
Limited English proficiency | 16 (47) |
Unknown | 1 (3) |
Race and ethnicity, n (%)a | |
American Indian or Alaskan Native, non-Hispanic | 0 |
Asian or Pacific Islander, non-Hispanic | 1 (3) |
Black or African American, non-Hispanic | 1 (3) |
White, non-Hispanic | 12 (35) |
Other, non-Hispanic | 1 (3) |
No. of years part of complex care service | |
0–1 | 11 |
2–4 | 11 |
5–10 | 4 |
11 or more | 8 |
Hospital staff and leaders (n = 46) | |
Age, y, mean (SD) | 50 (12) |
Gender, n (%) | |
Male | 8 (17) |
Female | 38 (83) |
Race and ethnicity, n (%)a | |
American Indian or Alaskan Native, non-Hispanic | 0 |
Asian or Pacific Islander, non-Hispanic | 7 (15) |
Black or African American, non-Hispanic | 0 |
White, non-Hispanic | 31 (67) |
Other, non-Hispanic | 2 (4) |
Hispanic | 6 (13) |
Unknown | 2 (4) |
Role, n (%)a | |
Attending physician | 11 (24) |
Case manager | 2 (4) |
Fellow | 1(2) |
Hospital leader | 16 (35) |
Lawyer | 3 (6) |
Nurse | 16 (35) |
Resident physician | 2 (4) |
Social worker | 4 (9) |
Columns may not add up to 100% as individuals could report more than 1 race and ethnicity or role.
Theme . | Subtheme . | Illustrative Quote . |
---|---|---|
Unclear, nontransparent, and variable existing processes | Nontransparent | “If I have concerns, who do I talk to?... I don't think I've ever had that conversation with anybody here…if you have any concerns at all, here's who you contact.” -Parent |
“I would say talk to your doctor about it first or talk to the nurse and make sure that they know what you’re thinking and then I think that if that went unnoted or ignored…the next step of who I should talk to and it’s not, then go to patient relations, but I would not know exactly what to tell them of how to do that.” -Physician | ||
Variable | “I would be the first line to try and do something about that to prevent a threat to the patient’s safety. I’ve never actually thought about reporting issues further up. Usually, if it seems like it’s a systemic issue, we would then report it on the parent’s behalf…and that is probably, you know, like not adequate, but we try to manage most of the parents’ concerns within our team without making reports unless we think that after investigation, a report is warranted, then we would do it on their behalf.” -Physician | |
Continuum of staff and leadership buy-in | Strong buy-in | “[Families] know the patient best, and I think… that’s why I think more of a candid conversation about…opening up and letting them know we are…we do try to create a culture of safety at [Hospital], and having those conversations has kind of become common…Just letting them know it’s okay if you have any safety concerns, please let us know.” -Nurse |
“Hey, you're key here. We want you to be involved. You know your child best. We want you to speak up and help as a part of this team.” -Leader | ||
Partial buy-in | “I think the family needs to be involved and we just have to get over these hurdles of how we manage the difficult challenging parent who demands so much on us.” -Nurse | |
“I would say it's 50/50, because I think people want families to speak up, but not too loudly…And those are families that are very vocal, that speak up when they have concerns...And more often than not, they're right. They get labeled as being difficult, right? And they clash with staff. There's a lot of conflict. People perceive them negatively as being confrontational and not going along with the plan, when I think the root of it is it takes more time, right? And you're busy, and you've got a job to do, and now you've got to stop what you're doing and do this.” -Hospital Leader | ||
Weak buy-in | “I don't know how you're going to [have families report], 'cause people are going to complain about everything. I think they'll complain about everything. I think people are very…lawsuits have gone up. I think people are very unhappy right now…I think you would just get a lot of complaints. I think people have a mechanism right now, and I don't know what you're trying to achieve by [introducing a new way for families to report].” -Leader | |
Family decision-making calculus about whether to report | Event characteristics | “I think it depends on how important the issue is. You know, if [it] was a true safety concern, I would probably speak up no matter what. Um… if it wasn't that big of a deal, maybe I wouldn't say anything and just fix it myself and keep going.” -Parent |
Trust and relationships | “And it may be that [families] only want to tell 1 particular person that they trust. You know? Like they may not trust us. They’re waiting for this 1 nurse who’s going to come back on tomorrow’s night shift and talk to her.” -Physician | |
Parent emotions and fears | “She might not get the care that she needs if I say something used to be my fear.” -Parent | |
“I can't just 100% rely on these people to make decisions for my child. I've learned I have to speak up more. I've learned leaving the hospital crying, feeling like I failed as a mother because I didn't do what I felt was right. I didn't do enough for my child.” -Parent | ||
Underlying motivations | “I used to stay quiet but now I speak up. If I have to tell the doctors anything, I tell them, “Look, she didn’t do this right, she did this wrong,” because we have to take into account the patient’s safety, nothing else.” -Parent | |
“You have to be comfortable that you've done everything you can do.” -Parent | ||
“My goal is that if this happened to me with [patient], it shouldn’t happen to any other patient…maybe parents don’t speak up or don’t pay close attention to how they’re about to bathe their child or how they’re going to attend to his needs, so I think that they should be more alert with things like this, like what happened to me with [patient]. Because it’s sad to know someone else is going through what I went through and have an even worse outcome.” -Parent | ||
Desired outcomes | “Goal in sharing would be like making sure it's resolved in the, you know, immediate future for my own kiddo. But then also bringing it to light so that hopefully carry over can occur for other patients as well.” -Parent | |
“Just for it to be acknowledged that…safety's important and it needs to be paid attention to. And that's not, it's not something you can just sort of let slide...So my goal would be to not only make sure that she's taken care of the right way, but to make sure that the person who maybe didn't do it the right way knows, so it's acknowledged that, you know, you can't just let that slide. You have pay attention to that or whatever that it's really important…‘Okay. I guess I need to, you know, really be on top of this’…‘Thank you for pointing that out. You're right. I should have done this this way’ and then just know that maybe they, it's more instilled in their mind.” -Parent | ||
Parent characteristics | “Women in [country] culture tend to be very outspoken, or at least pretty strong, so I’m very comfortable expressing myself. And the way that our parents raised us, I think we’re pretty diplomatic…adding to that, the fact that I can speak in a way that incorporates the lingo, the knowledge, it’s attributed more credibility when I’m speaking to a medical professional…but I also come from a culture of hierarchy and respect…that cultural kind of bias is not to question. But as a parent of a child who is very vulnerable I have to question. So there’s that friction emotionally to deal with that.” -Parent | |
“I mean for our [complex care] patients, I think that…well, I would say most of them are comfortable sharing safety concerns…most of these are families that have navigated the health care system for years, probably most of them since their kids were born, so they’re usually the first to report anything that they see that’s out of the norm for the child and are the most comfortable reporting it.” -Nurse | ||
“Everybody is a newbie when they first start out…you're just not sure what's the right thing, what's the wrong thing,..you just kind of expect that they know what they're doing. Just sit here and let them do what they need to do and you just want your child to be better so you're putting your trust and your faith in these professionals that know what to do…whatever they say is the best thing and you know, you just go with it. And that's it in the beginning because you don't know anything else and how are you supposed to know more than what a doctor's gone to school for years for?...I didn't say anything you know, until, time went on and time went on…but knowing my daughter, now I'm like, “No, I don't think that's going to work because this and this.”…So I feel more like a part of a team than when I was, you know, in the beginning of all this, I felt more like an outsider looking in, you know?” -Parent | ||
Misaligned priorities and expectations | Priorities | “Recently we had a mother who said to me the nurses aren't checking on the ileostomy bag enough, so it's exploding and then they're not taking care of the child's skin. ‘That means I have to be here all the time and I can't trust you.’ There's a lot of trust issues with these parents. So, it's dealing with that sort of thing and trying to get them to understand that we're in a hospital setting, not in a home setting with 1-on-1. But of course, they don't want to hear that their child is 1 of 2 and you have to weigh up how you’re going to manage the care for both patients, not just that patient.” -Nurse |
Expectations | “I expect them to be just as concerned, to be willing to communicate about it, not just shut it down, but to see what my expectations are, what they're able to do, what their job description is. And either come to the conclusion that either something is or isn't appropriate. And if it is, I expect, you know, the communication and the change to be happening for the care, if it is. And then if it isn't, you know, I expect people to be communicating what is not included, what is my responsibility and…what is everyone's goal. I, and I would hope that everybody would agree on what the whole goal is of everything, of the treatment, of the condition, of our communication. It should all be based on 1 goal for my daughter.” -Parent | |
Strategies for engaging staff and families | Extending an invitation | “During a hospitalization, the invitation we're making is on admission, ‘Look, lots of the care in a hospital is complicated, many different people, many different aspects of care for your child, and if you have questions along the way, we want to hear them right away, we want to...if you have concerns all along the way…’ I think that kind of proactive invitation is a start.” -Leader |
“Even soliciting do you have any questions or concerns, ‘cause sometimes people need that invitation.” -Parent | ||
Keeping it simple | “I think the easier that you can do it, the simpler you can do it, so just like either just, you know, like a couple of drop-down menus so that you can like sort things out but not too many because the more fields they have to fill, the less likely I feel that they will do it, right?” -Physician | |
“I think in this overburdened world, it's being able to give people 3 quick strategies that allows them to embrace patient safety and how they can better engage patients and families…it needs to be 3, very quick, strategies…simple questions they can ask or simple tools.” -Leader | ||
Offering choice | “I think having multiple options available is really helpful…there’s people that are really savvy with computers and text messages. There’s people that would just rather write a quick comment…it’s not something that requires a lot of additional thinking because you’re not really in the moment to be thinking about tons of other things when you’re in the hospital with your child.” -Parent | |
Acknowledging family expertise | “I think the parents don't get listened to properly and I think that's a key thing to safe care. You must listen to the parent. They know their child and these parents, particularly on [unit], are very skilled at taking care of their complex patient and child. They really do know what they're talking about.” -Nurse | |
“And even if they're professionals, even professionals make mistakes. And even professionals may not know your child better than you know your child.” -Parent | ||
Providing language for families | “Because what [families] may perceive as a safety concern, they may not have the language—to be able to raise to the level, um, of a concern to get the attention of a provider, clinician...first is building a language, is 1 of the biggest opportunities that I can see.” -Hospital Leader | |
Family and staff education | “‘Your opinion matters… This is your child, you know. So you’re a part of the team too…Voice your opinion…If it’s not gonna work, we’ll explain to you why we know it’s not gonna work’…Tell the parents write down questions…Leave a little pad of paper or something and a pen…‘If you think of questions, write down for when they come in for rounds”...Even writing a little pamphlet maybe…with…little pointers…helpful hints.” -Parent | |
Providing follow-up | “Sometimes, it is, ‘I’m sorry this was done incorrectly, but we are taking measures to do x, y, and z. We are very sorry. We’ve done [these things] to make it better’…Telling them the why and telling them you’re working on a solution, and that transparency really does go a long way.” -Nurse |
Theme . | Subtheme . | Illustrative Quote . |
---|---|---|
Unclear, nontransparent, and variable existing processes | Nontransparent | “If I have concerns, who do I talk to?... I don't think I've ever had that conversation with anybody here…if you have any concerns at all, here's who you contact.” -Parent |
“I would say talk to your doctor about it first or talk to the nurse and make sure that they know what you’re thinking and then I think that if that went unnoted or ignored…the next step of who I should talk to and it’s not, then go to patient relations, but I would not know exactly what to tell them of how to do that.” -Physician | ||
Variable | “I would be the first line to try and do something about that to prevent a threat to the patient’s safety. I’ve never actually thought about reporting issues further up. Usually, if it seems like it’s a systemic issue, we would then report it on the parent’s behalf…and that is probably, you know, like not adequate, but we try to manage most of the parents’ concerns within our team without making reports unless we think that after investigation, a report is warranted, then we would do it on their behalf.” -Physician | |
Continuum of staff and leadership buy-in | Strong buy-in | “[Families] know the patient best, and I think… that’s why I think more of a candid conversation about…opening up and letting them know we are…we do try to create a culture of safety at [Hospital], and having those conversations has kind of become common…Just letting them know it’s okay if you have any safety concerns, please let us know.” -Nurse |
“Hey, you're key here. We want you to be involved. You know your child best. We want you to speak up and help as a part of this team.” -Leader | ||
Partial buy-in | “I think the family needs to be involved and we just have to get over these hurdles of how we manage the difficult challenging parent who demands so much on us.” -Nurse | |
“I would say it's 50/50, because I think people want families to speak up, but not too loudly…And those are families that are very vocal, that speak up when they have concerns...And more often than not, they're right. They get labeled as being difficult, right? And they clash with staff. There's a lot of conflict. People perceive them negatively as being confrontational and not going along with the plan, when I think the root of it is it takes more time, right? And you're busy, and you've got a job to do, and now you've got to stop what you're doing and do this.” -Hospital Leader | ||
Weak buy-in | “I don't know how you're going to [have families report], 'cause people are going to complain about everything. I think they'll complain about everything. I think people are very…lawsuits have gone up. I think people are very unhappy right now…I think you would just get a lot of complaints. I think people have a mechanism right now, and I don't know what you're trying to achieve by [introducing a new way for families to report].” -Leader | |
Family decision-making calculus about whether to report | Event characteristics | “I think it depends on how important the issue is. You know, if [it] was a true safety concern, I would probably speak up no matter what. Um… if it wasn't that big of a deal, maybe I wouldn't say anything and just fix it myself and keep going.” -Parent |
Trust and relationships | “And it may be that [families] only want to tell 1 particular person that they trust. You know? Like they may not trust us. They’re waiting for this 1 nurse who’s going to come back on tomorrow’s night shift and talk to her.” -Physician | |
Parent emotions and fears | “She might not get the care that she needs if I say something used to be my fear.” -Parent | |
“I can't just 100% rely on these people to make decisions for my child. I've learned I have to speak up more. I've learned leaving the hospital crying, feeling like I failed as a mother because I didn't do what I felt was right. I didn't do enough for my child.” -Parent | ||
Underlying motivations | “I used to stay quiet but now I speak up. If I have to tell the doctors anything, I tell them, “Look, she didn’t do this right, she did this wrong,” because we have to take into account the patient’s safety, nothing else.” -Parent | |
“You have to be comfortable that you've done everything you can do.” -Parent | ||
“My goal is that if this happened to me with [patient], it shouldn’t happen to any other patient…maybe parents don’t speak up or don’t pay close attention to how they’re about to bathe their child or how they’re going to attend to his needs, so I think that they should be more alert with things like this, like what happened to me with [patient]. Because it’s sad to know someone else is going through what I went through and have an even worse outcome.” -Parent | ||
Desired outcomes | “Goal in sharing would be like making sure it's resolved in the, you know, immediate future for my own kiddo. But then also bringing it to light so that hopefully carry over can occur for other patients as well.” -Parent | |
“Just for it to be acknowledged that…safety's important and it needs to be paid attention to. And that's not, it's not something you can just sort of let slide...So my goal would be to not only make sure that she's taken care of the right way, but to make sure that the person who maybe didn't do it the right way knows, so it's acknowledged that, you know, you can't just let that slide. You have pay attention to that or whatever that it's really important…‘Okay. I guess I need to, you know, really be on top of this’…‘Thank you for pointing that out. You're right. I should have done this this way’ and then just know that maybe they, it's more instilled in their mind.” -Parent | ||
Parent characteristics | “Women in [country] culture tend to be very outspoken, or at least pretty strong, so I’m very comfortable expressing myself. And the way that our parents raised us, I think we’re pretty diplomatic…adding to that, the fact that I can speak in a way that incorporates the lingo, the knowledge, it’s attributed more credibility when I’m speaking to a medical professional…but I also come from a culture of hierarchy and respect…that cultural kind of bias is not to question. But as a parent of a child who is very vulnerable I have to question. So there’s that friction emotionally to deal with that.” -Parent | |
“I mean for our [complex care] patients, I think that…well, I would say most of them are comfortable sharing safety concerns…most of these are families that have navigated the health care system for years, probably most of them since their kids were born, so they’re usually the first to report anything that they see that’s out of the norm for the child and are the most comfortable reporting it.” -Nurse | ||
“Everybody is a newbie when they first start out…you're just not sure what's the right thing, what's the wrong thing,..you just kind of expect that they know what they're doing. Just sit here and let them do what they need to do and you just want your child to be better so you're putting your trust and your faith in these professionals that know what to do…whatever they say is the best thing and you know, you just go with it. And that's it in the beginning because you don't know anything else and how are you supposed to know more than what a doctor's gone to school for years for?...I didn't say anything you know, until, time went on and time went on…but knowing my daughter, now I'm like, “No, I don't think that's going to work because this and this.”…So I feel more like a part of a team than when I was, you know, in the beginning of all this, I felt more like an outsider looking in, you know?” -Parent | ||
Misaligned priorities and expectations | Priorities | “Recently we had a mother who said to me the nurses aren't checking on the ileostomy bag enough, so it's exploding and then they're not taking care of the child's skin. ‘That means I have to be here all the time and I can't trust you.’ There's a lot of trust issues with these parents. So, it's dealing with that sort of thing and trying to get them to understand that we're in a hospital setting, not in a home setting with 1-on-1. But of course, they don't want to hear that their child is 1 of 2 and you have to weigh up how you’re going to manage the care for both patients, not just that patient.” -Nurse |
Expectations | “I expect them to be just as concerned, to be willing to communicate about it, not just shut it down, but to see what my expectations are, what they're able to do, what their job description is. And either come to the conclusion that either something is or isn't appropriate. And if it is, I expect, you know, the communication and the change to be happening for the care, if it is. And then if it isn't, you know, I expect people to be communicating what is not included, what is my responsibility and…what is everyone's goal. I, and I would hope that everybody would agree on what the whole goal is of everything, of the treatment, of the condition, of our communication. It should all be based on 1 goal for my daughter.” -Parent | |
Strategies for engaging staff and families | Extending an invitation | “During a hospitalization, the invitation we're making is on admission, ‘Look, lots of the care in a hospital is complicated, many different people, many different aspects of care for your child, and if you have questions along the way, we want to hear them right away, we want to...if you have concerns all along the way…’ I think that kind of proactive invitation is a start.” -Leader |
“Even soliciting do you have any questions or concerns, ‘cause sometimes people need that invitation.” -Parent | ||
Keeping it simple | “I think the easier that you can do it, the simpler you can do it, so just like either just, you know, like a couple of drop-down menus so that you can like sort things out but not too many because the more fields they have to fill, the less likely I feel that they will do it, right?” -Physician | |
“I think in this overburdened world, it's being able to give people 3 quick strategies that allows them to embrace patient safety and how they can better engage patients and families…it needs to be 3, very quick, strategies…simple questions they can ask or simple tools.” -Leader | ||
Offering choice | “I think having multiple options available is really helpful…there’s people that are really savvy with computers and text messages. There’s people that would just rather write a quick comment…it’s not something that requires a lot of additional thinking because you’re not really in the moment to be thinking about tons of other things when you’re in the hospital with your child.” -Parent | |
Acknowledging family expertise | “I think the parents don't get listened to properly and I think that's a key thing to safe care. You must listen to the parent. They know their child and these parents, particularly on [unit], are very skilled at taking care of their complex patient and child. They really do know what they're talking about.” -Nurse | |
“And even if they're professionals, even professionals make mistakes. And even professionals may not know your child better than you know your child.” -Parent | ||
Providing language for families | “Because what [families] may perceive as a safety concern, they may not have the language—to be able to raise to the level, um, of a concern to get the attention of a provider, clinician...first is building a language, is 1 of the biggest opportunities that I can see.” -Hospital Leader | |
Family and staff education | “‘Your opinion matters… This is your child, you know. So you’re a part of the team too…Voice your opinion…If it’s not gonna work, we’ll explain to you why we know it’s not gonna work’…Tell the parents write down questions…Leave a little pad of paper or something and a pen…‘If you think of questions, write down for when they come in for rounds”...Even writing a little pamphlet maybe…with…little pointers…helpful hints.” -Parent | |
Providing follow-up | “Sometimes, it is, ‘I’m sorry this was done incorrectly, but we are taking measures to do x, y, and z. We are very sorry. We’ve done [these things] to make it better’…Telling them the why and telling them you’re working on a solution, and that transparency really does go a long way.” -Nurse |
Theme 1: Unclear, Nontransparent, and Variable Existing Processes
Interviews revealed several existing processes for family safety reporting at both institutions. Most commonly, parents informally shared concerns with providers, particularly bedside nurses, physicians, or trusted subspecialists. Parents with limited English proficiency frequently expressed concerns to clinical and nonclinical staff (eg, housekeeping) speaking their language. When concerns were inadequately addressed, parents escalated to local leadership (eg, charge nurse) or patient relations. Informal and formal processes existed but were unclear (both to staff and parents), nontransparent, and variably used across both institutions.
Staff and parents at both hospitals described lack of clarity about how families could report safety concerns and lack of transparency after reports were made. Some parents were unaware of patient relations. After staff filed a VIR or families contacted patient relations, staff and families were not always informed if an investigation occurred. Changes directly resulting from family safety reports (eg, medication reconciliation initiatives) were not always publicized as being inspired by families.
Whether and how follow-up occurred after families raised concerns varied. Staff often addressed family safety concerns themselves, only entering them into VIR if they were deemed systems issues. Participants stated responses to families’ verbal reports varied based on perceived staff personality (eg, open versus defensive) and managerial style (eg, prioritizing staff over family perspectives).
Theme 2: A Continuum of Staff and Leadership Buy-in
Unclear, nontransparent, and variable existing processes underlied a fundamental challenge: lack of universal staff and leader buy-in about family safety reporting. There was consensus among all respondent groups that families (especially of CMC) know their child best and should be partners in care. However, this belief did not always translate into buy-in that family input should inform systems change.
Staff and leader buy-in about family safety reporting existed along a continuum (Fig 2). Those with strong buy-in described listening to, partnering with, and cutting families “slack” (acknowledging hospitalization-related stressors). They welcomed mechanisms to make family reporting more accessible. Their motivations for family reporting included family-centeredness, recognizing families possess critical information, ethics (eg, families’ right to speak up), and systems improvement.
Staff and leaders partially buying-in to family reporting wanted families to speak up nonemotionally and not unduly increase workload for nonpressing concerns. They were less likely to listen when families shared in angry or emotional ways and sometimes avoided “difficult” families.
Staff and leaders lacking buy-in raised concerns about validity and usefulness of family reports, questioning whether families would provide new, actionable, or true safety information. They worried reports would instead represent complaints about quality and service delivery or ignorance about routine care-delivery processes (eg, 15-minute medication-administration delays). These staff and leaders also questioned parent motivations, attributing reporting, particularly when anonymous, to “blowing off steam” or anger. Frontline staff experienced negative emotions when families reported (eg, felt threatened, blamed, afraid of litigation or job termination). Some staff and leaders worried families would fear or mistrust healthcare if safety was discussed openly. Others believed we should not “rely” on parents to ensure safe care. Some staff and leaders noted tension between patient relations and the medical team (the latter perceiving the former as punitive, unsupportive, and deferential to families). Other concerns included data security and regulatory adherence.
Lack of staff and leader buy-in also resulted from mistrust of VIR, independent of families. Some viewed VIR as punitive and blaming. Some leaders discouraged safety reports, believing they reflected poorly on their leadership. Staff and leaders did not always view family safety reporting as high priority given competing financial, educational, and clinical priorities. Mistrust about validity, usefulness, motivations, and appropriateness of family reports culminated in fear that family reporting might “open Pandora’s box” and require additional staffing, time, and energy to address an overwhelming number of low-yield family reports.
Theme 3: Family Decision-making Calculus About Whether to Report
Families made a calculated decision about whether to report safety concerns. Many factors affected when, where, how, why, and to whom they reported. Along with the nontransparent and variable existing processes above, factors included event characteristics, interpersonal factors, past experiences with reporting, trust and relationships, emotions surrounding the event, and strong underlying motivations and desired outcomes from reporting. Families often “let things slide,” selectively choosing which concerns to share.
Event characteristics included severity and likelihood of reoccurrence to the patient or others. Interpersonal factors included staff demeanor (eg, curt versus friendly). Past negative experiences with reporting, like lack of follow-up with previous reports, made some families feel reporting was futile. Negative past staff reactions, like defensiveness, blaming parent, dismissing concerns, or making excuses, also deterred reporting.
Trust and relationships could facilitate or hamper family reporting. Families who trusted and had relationships with providers were more likely to speak up. However, families sometimes refrained from speaking up to avoid getting favorite providers in trouble. Some families felt providers were doing their best and feared bothering or offending them by expressing concerns.
Parent emotions and fears included worries about sounding “stupid,” being labeled “difficult,” facing retaliation, fatalism (“nothing ever comes of it”), and awkwardness about speaking up but guilt over not speaking up.
Strong underlying motivations and desired outcomes provided parents self-efficacy to report. Motivations included feeling heard, being the voice of the voiceless, and documenting concerns in writing. Desired outcomes included preventing harm and improving care for their child and others, doing everything they could for their child, and fixing immediate issues. Parents stated they would advocate for their children in ways they would not for themselves.
The decision-making calculus evolved with time and experience. Parents stated they were less likely to speak up when they were new to complex care. Parents described becoming more comfortable speaking up over time as they became familiar with the healthcare system and its fallibility, recognized their own expertise, and realized speaking up would not negatively affect care. Parent characteristics, including personality (eg, reserved versus extroverted), language proficiency, and education, also affected the calculus. More assertive and educated families were “believed” more, which might make them more likely to report. Deference to authority, which some attributed to family upbringing, particularly for parents with limited English proficiency, also affected parent willingness to raise concerns. Similarly, hierarchy and power differentials made families afraid to speak up (eg, nonmedical background, lower education). Parents also sometimes felt too overwhelmed by their child’s illness and stressors of hospitalization to report concerns.
Theme 4: Misaligned Staff and Parent Priorities and Expectations
Parent and staff priorities and expectations for care differed. A disconnect between parents and staff about the importance and urgency of addressing parent safety concerns resulted. Parents sometimes considered delays in care delivery to be pressing safety concerns (eg, not giving medications at the exact time). In contrast, staff weighed competing patient care responsibilities and accepted some lapses as inevitable limitations of complex systems. The discrepancy in importance that staff versus parents assigned to events led to misaligned expectations about how urgently solutions or responses were expected. Parents often expected immediate resolution, although while staff expected more gradual resolution or even no resolution because of limitations of hospital processes.
Expected outcomes from families included gratitude and reassurance that concerns were heard, investigated, addressed efficiently, apologized for, and would not negatively affect care. Families expected concerns would be taken seriously, lead to discrete actions (eg, policy change), and not reoccur. In contrast, staff often prioritized the process by which families reported over outcomes. Staff expected families to share concerns respectfully and raise concerns that were addressable, real, and did not inordinately increase workload. They accordingly triaged family concerns based on whether they were time-sensitive, valid, and actionable.
Strategies for Engaging Families and Staff
Parents, staff, and leaders suggested strategies to promote engagement in family safety reporting (Fig 3). One parent stated an invitation to share concerns from even 1 provider would have made them more comfortable speaking up sooner. Preferences for reporting modality varied; some parents preferred paper, others e-mail or text-message. To accommodate variable preferences, families recommended flexibility and choice in reporting modality, identifying no “one-size-fits-all” solution. Most were comfortable reporting nonanonymously but preferred anonymous reporting for sensitive interpersonal matters (eg, alcohol on provider’s breath). There was consensus to keep reporting tools simple, easy-to-use, and available in multiple languages. Parents and staff emphasized the importance of providing families sample language to express safety concerns (eg, “I’m worried…”). Suggestions for training families and staff about family safety reporting included framing reporting around altruism (improving care for all patients), emphasizing family expertise and importance of family engagement, giving families permission to speak up, and teaching staff how to elicit and respond to family concerns.
Discussion
Our findings provide a framework for operationalizing family safety reporting. Although family safety reporting processes existed at both institutions, they were variable and unclear to parents and staff. Processes for reporting and follow-up after parents made a report were nontransparent. Lack of transparency in safety reporting, review, and follow-up undermined efforts to highlight the importance of family reporting to staff and families. Staff and leadership buy-in about family safety reporting existed along a continuum and families undertook a complex decision-making calculus when deciding whether to report. Staff and family priorities and expectations about family safety reporting were often misaligned. We accordingly identified strategies to inform future interventions. These include framing reporting around improving safety for the patient and other patients, extending families an invitation to report, and keeping reporting options simple, multimodal, and multilingual.
Prior studies indicate that providers support family involvement in safety.25–28 However, the disconnect between staff verbally supporting family involvement although not fully buying into the utility of family safety reporting is a novel finding. Patients can detect insincerity29–31 ; therefore, staff sincerity in inviting families to share concerns matters. Our finding about the importance of extending an invitation is consistent with our prior research suggesting more proactive family safety reporting approaches (eg, interviews) yield greater reporting than passive approaches (eg, hotlines).3,4,6 Some decision-making calculus elements that families reported as barriers to family reporting, eg, fear of retribution and burdensome nature of reporting, are also barriers to staff VIR.16,17,32,33 However, diffusion of responsibility and belief that certain errors are too commonplace to report are staff barriers to VIR16,17,32,33 we did not identify as barriers to family safety reporting. Family reporting can therefore identify errors staff perceive as too commonplace to report or assume someone else will report, thereby holding hospitals accountable to ensure improvements occur.
Lack of staff buy-in may result from hierarchy, paternalism, misconceptions about family ignorance, and worry that families will fear hospitals if hospitals openly discuss safety. Staff buy-in may be a variable “state,” not fixed “trait,” fluctuating over time, role, and training. Although some staff believed hospitals should not “rely” on families, in reality, hospitals do rely on families to provide information about quality and clinical care. Patients and families are vigilant partners in care34 who possess specific knowledge complementing staff expertise that can help improve hospital safety and quality. Patients and families provide critical historical information, identify subtle changes from baseline, sometimes before staff,35–37 and recognize issues staff may not notice or bother reporting. Patient and family-reported safety events are distinct from and complementary to staff-reported ones3–5,7,38 and help hospitals identify otherwise unrecognized safety issues. Our findings also suggest that, particularly over time, patients and families recognize that hospital errors are commonplace.
Though processes for family reporting exist, many rely on parents indirectly, like staff reporting concerns in VIR on behalf of patients and families. Since staff infrequently use VIR,16 hospitals likely do not formally document most events families report to staff. Our data suggest staff selectively enter family concerns into VIR only if families identify errors without preexisting safeguards (eg, dose alerts) or issues warranting advocacy (eg, iPad interpreter scarcity). This selectivity may result from altruism and personal responsibility or avoiding red tape, tattling, and excessive workload. Regardless, by failing to reliably track family safety reports, hospitals miss important opportunities to address safety issues meaningful to families and identify system-level solutions.
Strategies to increase staff and leadership buy-in, both about safety reporting generally and family safety reporting specifically, are necessary. Openly sharing data and stories, including how family reporting has stimulated safety improvements, may increase buy-in.39 Other strategies to address buy-in include campaigns about the importance of engaging families in safety reporting, publicizing changes that family reporting inspired, sharing stories that demonstrate the importance of family safety reporting, and sharing data. For instance, hospitals can showcase family-generated improvement efforts via posters displayed on units. Unit and hospital leadership can transform organizational culture by modeling meaningful family partnerships (eg, including families on committees, practicing family-centered rounds, encouraging family reporting). Strategies to support staff in documenting and addressing family reports are also needed. A welcoming environment where staff actively listen, invite input, and are open to hearing patient and family concerns at all levels is essential. In our study, staff and families alike were strongly motivated by altruism to improve care for all patients. Positively framing family safety reporting interventions to staff and families alike around shared motivations (eg, “help make care safer for your patient and all patients”) can help all groups embrace safety reporting in a nonthreatening manner. Recognizing that hospitals may lack the capacity to fully investigate an influx of family safety reports, hospitals may need to dedicate additional resources and staff support for family safety reporting. However, family safety reporting has the potential to improve safety, quality, and experience for patients and families and therefore, warrants additional investment, even in the context of limited resources.
For families, no one-size-fits-all solution exists. Beyond reporting mode, a menu of simple, transparent, flexible, and multilingual options is important. Although seasoned parents remarked they eventually learned to share concerns, this took time, familiarity, and learning their input mattered and would not negatively affect care. Thus, providers must proactively invite patients and families to speak up. Because families cited fear of retribution as a major barrier to reporting, staff should reassure families that reporting is not intended to get anyone in trouble and will not negatively affect care. Finally, from an equity standpoint, hospitals must proactively encourage concerns from systematically disadvantaged families, whether due to language barriers, education, race and ethnicity, or other factors.40–42 By better engaging all families, particularly disadvantaged ones, hospitals can decrease disparities in safety43 and quality. If only privileged families are invited to share concerns, disparities may widen.
Our study has several limitations. It was conducted with English and Spanish-speaking caregivers and staff at 2 tertiary care hospitals with complex care services. Our sample of staff and leaders, reflecting staff demographics in both hospitals, was a largely White group. As is accepted practice in qualitative research, we conducted purposive, criteria-based sampling to provide the rich, contextual information necessary to inform development of family safety reporting interventions. Our selection of participants based on characteristics previously associated with family safety reporting, including education, language, and experience with complex care, and achievement of thematic saturation allow our findings to be potentially transferable to other like-hospitals for consideration. However, patients and families who are not part of formal complex care services and from additional racial, ethnic, linguistic, and socioeconomic backgrounds may have different experiences. Additionally, COVID-19 made recruitment, particularly of Spanish-speaking parents, challenging, although adding bilingual team members and conducting interviews virtually improved recruitment. The pandemic’s impact on family safety reporting and experiences of additional patient, caregiver, and staff populations warrants further study.
Conclusions
In a 2-center qualitative study of parents, staff, and hospital leaders of CMC, we found that family safety reporting is complex and hampered by unclear, nontransparent, and variable existing processes. These limitations may prevent reliable tracking of family concerns and organizations’ ability to identify, learn from, and apply opportunities for improvement. Many staff and leaders lack buy-in about family reporting, and parent-staff priorities and expectations are misaligned. Accordingly, families engage in a complex decision-making calculus when deciding whether to report concerns. Informed by multiple perspectives, we identified strategies to facilitate family safety reporting in a manner attuned to varied stakeholder needs. These strategies include identifying shared parent and staff motivations, like improving care for all patients. Staff should explicitly invite families (and patients) to share concerns and reassure them that their expertise is valuable and that reporting will not negatively affect care. Hospitals can make reporting simple, flexible, multilingual, and equitable, and ensure follow-up occurs, but may need to devote additional resources to support staff and families. Ultimately, families recognize safety concerns hospitals and staff might otherwise miss or fail to act upon. Engaging families in safety reporting has the potential to improve patient safety in novel ways prioritized by families.
Dr Khan conceptualized and designed the study, obtained funding, acquired data, performed qualitative analyses, analyzed and interpreted data, and drafted the initial manuscript; Dr Baird designed the study, acquired data, performed qualitative analyses, analyzed and interpreted data, and drafted the manuscript; Dr Kelly participated in study design, performed qualitative analyses, and analyzed and interpreted data; Mr Blaine, Dr Chieco, and Ms Lopez participated in study design, acquired data, and analyzed and interpreted data; Ms Haskell provided intellectual advice and guidance for the study, participated in study design, and analyzed and interpreted data; Ms Ngo participated in study design, acquired, entered, analyzed, and interpreted data, performed quantitative analysis, tabulated the article, and provided administrative support; Ms Mercer designed the study, acquired, entered, analyzed and interpreted data, and provided administrative support; Dr Quinones-Perez participated in study design, acquired data, and analyzed and interpreted data; Dr Schuster, Singer, Viswanath, and Landrigan provided intellectual advice and guidance for the study; Dr Williams participated in study design, provided intellectual advice and methodological guidance for the study, and analyzed and interpreted data; and Dr Luff supervised and designed the study, provided intellectual advice and methodological guidance for the study, analyzed and interpreted data, and drafted the manuscript; and all authors critically reviewed and revised the manuscript for important intellectual content and approved the final manuscript as submitted.
FUNDING: Support for this work was provided by an Agency for Healthcare Research & Quality K08HS025781 grant (PI Khan) and an American Pediatric Association Young Investigator Award (PI Khan). The views expressed herein are those of the authors and do not necessarily represent those of the funding sources.
CONFLICT OF INTEREST DISCLOSURES: Dr Landrigan has served as a paid consultant to the Midwest Lighting Institute to help study the effect of blue light on health care provider performance and safety. Dr Landrigan has consulted with and holds equity in the I-PASS Institute, which seeks to train institutions in best handoff practices and aid in their implementation. Dr Landrigan has received consulting fees from the Missouri Hospital Association and Executive Speakers Bureau for consulting on I-PASS. In addition, Dr Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety, and has served as an expert witness in cases regarding patient safety and sleep deprivation. Dr Baird has consulted for the I-PASS Institute. All other authors have no conflicts of interest to disclose.
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