Family Safety Reporting in Hospitalized Children With Medical Complexity

From April 2018 to April 2019, we conducted a 5-unit prospective cohort study of patients hospitalized on a dedicated complex care service at a tertiary care children’s hospital. The hospital has a formal voluntary incident reporting (VIR) system available only to staff. Families lack a formal safety reporting method other than submitting complaints to Patient Relations, which is infrequently used. The hospital’s institutional review board approved this study.

We included all English- and Spanish-speaking parents of hospitalized CMC and staff on the study units. Research assistants screened and recruited eligible parents daily. We excluded parents of international patients and patients in state custody or residential care facilities. Participants provided verbal consent facilitated by an information sheet.

Parents completed a 41-item survey, including select Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) items¹⁴  and family safety reporting, experience, and safety belief items modified from previous research.^12,15  We cognitive validity tested, piloted, and professionally translated surveys into Spanish. Parents also completed the Children’s Hospital Safety Climate Questionnaire,¹⁶  Parent-Patient Activation Measure,¹⁷  Newest Vital Sign (for health literacy),¹⁸  and demographic items.

Staff completed surveys based on previous research¹⁵  about perceptions of family safety reporting, safety beliefs/training, experience, select items from the Agency for Healthcare Research and Quality’s Hospital Survey on Patient Safety Culture,¹⁹  and demographics. Parents/staff completed surveys on paper or electronically.

We surveyed parents on weekdays 24 to 48 hours before anticipated discharge. Readmitted parents received an abbreviated survey focused on safety reporting items. We surveyed staff during meetings, study lunches, and clinical shifts. We obtained additional patient clinical/demographic information from Pediatric Health Information System²⁰  and a hospital-specific administrative database.

The primary outcome was the proportion of parents/caregivers (hereafter "families") of CMC with safety concerns. Additional outcomes included the proportion of staff who received family-reported concerns, safety concern frequency/type, “top-box” family/staff safety climate scores, and family/staff safety reporting experience.

Families were considered to have a safety concern if they answered affirmatively to ≥1 of 6 questions on our safety survey: illness got worse because of medical care, or because something was not done that should have been, nonharmful mistake, “good catch,” concerns not listened to, anything else upsetting or potentially harmful. Parents also provided additional details about their most recent (if >1) safety concern.

We classified concerns on the basis of a modified Bates et al approach^21,22  and our previous family safety reporting research.^12,13  A trained physician reviewed and classified all family concerns, reviewing medical records if there was insufficient information to classify each. Two physicians (Drs Khan and Landrigan) reviewed a random subset (17%) to check reliability (Κ = 0.77, 95% confidence interval [CI] 0.53–1.00). We classified concerns as safety concerns, nonsafety-related quality issues, or medical care concerns deemed neither safety nor quality problems. We subclassified safety concerns as harmful/nonharmful errors and categorized safety and nonsafety-related quality issues by type (eg, communication).

Staff received a family safety report if they answered affirmatively to whether a parent/caregiver of CMC in the past week reported to them a harm, nonharmful error, or safety concern. We also asked staff if families made any “good catches.” For safety experience, we analyzed the proportion of parents answering “yes, somewhat”/“yes, definitely” to the Child HCAHPS item about whether staff informed parents how to report concerns during hospitalization.¹⁴  For safety climate, respondents had a top-box safety climate score if they selected the top-most response on 5-point Likert scale questions (eg, 5/5, “Strongly Agree”).

Descriptive statistics were used to analyze the proportion of families with safety concerns and compared patient/parent sociodemographics among parents with versus without concerns. χ² tests were used to compare parent and staff reporting preferences and safety climate scores.

To identify factors associated with family safety concerns, we dichotomized the sample into patients with ≥1 family safety concerns versus none. We examined bivariate associations between having safety concerns and covariates of interest using χ²/Fisher’s exact tests for categorical variables. For continuous variables, we assessed associations using t tests for means and Wilcoxon Mann-Whitney tests for medians.

We used mixed-effects logistic regression with random intercepts controlling for clustering by participants to examine characteristics associated with families having safety concerns. We adjusted for patient/parent predictors deemed clinically significant a priori, including parent race/ethnicity, language proficiency, education, and health literacy, as well as patient age, number of lifetime admissions, and length of stay (LOS). P values <.05 were considered statistically significant. We used REDCap²³  for data collection and management and SAS v9.4 (SAS Institute) for analyses.

Overall, 74% (n = 175) of eligible parents and 77.9% (n = 230) of staff consented to participate (eFig 1). Surveys were completed by 155 parents and 214 staff (>89% response rates). Parents were predominantly White (74%, n = 114), female (81%, n = 123), and with less than a college education (51%, n = 78). Staff were predominantly nurses (59%, n = 122), female (91%, n = 190), and White (77%, n = 161). Mean LOS was 9 days (standard deviation = 13.5). The most common CCC categories were neurologic/neuromuscular (79%, n = 118), gastrointestinal (76%, n = 114), and metabolic (28%, n = 42); 86% (n = 129) were technology-dependent, including 11% (n = 17) who were mechanically ventilated (Table 1).

Overall, 43% (n = 66) of parents had ≥1 safety concerns during hospitalization. Parents had 115 total concerns (1–6 concerns each). After physician review, 69% (n = 79) of concerns were medical errors and 22% (n = 25) were nonsafety-related quality issues (eg, communication problem) (Fig 1). The remainder (10%, n = 11) were neither safety nor quality-related concerns (eg, valid, differing opinions about the care plan). Among errors, 27% (n = 21) were harmful (ie, preventable AEs) and 73% (n = 58) were nonharmful. The most frequent harmful errors involved medications/intravenous (IV) fluids (n = 8) and equipment (n = 4) (Fig 1). Harmful errors included an inadequately monitored IV that infiltrated, hypoxia from fluid overload, and delayed intussusception diagnosis (Table 2). The most frequent nonharmful errors involved medications/IV fluids (n = 23) and feeds (n = 9). Nonharmful errors included delayed laboratory results, noncompliance with orthotics, and delayed medication administration.

In unadjusted analysis, characteristics associated with family safety concerns were education, income, and LOS (Table 1). In adjusted multivariable analysis, college education or higher (adjusted odds ratio [aOR] 2.94, 95% CI [1.21–7.14], P = .02) and LOS >5 days (aOR 3.08, 95% CI [1.29–7.38], P = .01) were associated with family safety concerns (Table 3).

When providing additional details about their safety concerns, 31% (n = 20) of family concerns were “good catches” and 20% (n = 13) mistakes not harming the child. Overall, 68% of parents with safety concerns reported concerns to staff (n = 43), predominantly a bedside nurse (86%, n = 37), doctor (44%, n = 19), or charge nurse (16%, n = 7). Only 2% (n = 1) reported to Patient Relations. Most reported nonanonymously (98%, n = 42), verbally in person (95%, n = 41), and immediately (74%, n = 32). Desired outcomes after reporting were fixing the problem (65%, n = 28) and preventing it from happening to others (33%, n = 14). After parents reported their concern, 21% (n = 9) stated medical care changed and 16% (n = 7) stated someone apologized. Most parents were very/extremely satisfied (62%, n = 15) with staff response to reports. For the 32% who did not tell staff, the most common reasons were that it was “not a big deal” (35%, n = 7) and not wanting to be perceived as “difficult” (20%, n = 4). Most parents (68%, n = 89) responded “no” to the Child HCAHPS item asking whether staff had told them how to report concerns about mistakes during hospitalization.

Overall, 84% (n = 177) of staff versus 70% (n = 109) of parents said it was parents’, doctors’, nurses’, and other hospital staffs’ job together to ensure children receive safe hospital care (P = .001) as opposed to it being only parents’ or specific hospital staffs’ job. Parents and staff had similar responses for most safety climate survey items (Fig 2). However, staff were more likely than parents to agree/strongly agree that there were safety problems in the unit (31% of staff versus 5% of parents, P < .001). Staff were also less likely to agree/strongly agree that patient safety is never sacrificed to get more work done (48% of staff versus 73% of parents, P < .001).

Complex care staff received 28 family reports total. Overall, 17% (n = 23) of staff received a family-reported harmful error (n = 2), nonharmful error (n = 13), or safety concern (n = 13) over the past week. Medication concerns (36%, n = 10) and family–staff communication problems (18%, n = 5) were most common. Events included omitted seizure medication, a clogged enteral tube, missed chest physiotherapy, and incorrectly documented patient code status.

Staff primarily responded to family concerns by apologizing (67%, n = 16) or telling their supervisor (50%, n = 12). Only 21% (n = 5) filed a VIR in response to family concerns. Patient care changed in 56% (n = 13) of cases. Parents shared concerns with staff during exams/cares/vitals (59%, n = 82), at start of shift (49%, n = 67), or on rounds (41%, n = 56).

Overall, 4% (n = 6) of staff reported parents/caregivers made “good catches” in the past week, including correcting medication routes and missed feeds. Staff responded by thanking families (33%, n = 2) or apologizing (17%, n = 1). None reported filing a VIR in response to parents’ “good catches.”

Only 31% (n = 41) of staff reported usually/always asking families about safety concerns and 55% (n = 114) reported being very/extremely comfortable hearing from parents/caregivers about medical errors/AEs during hospitalization. Few reported receiving formal training about instructing families on sharing safety concerns (26%, n = 53) or responding to family safety concerns (32%, n = 65). Staff preferred families share safety concerns with nurses (91%, n = 191), resident physicians (66%, n = 138), or attending physicians (57%, n = 120); and that families report concerns in person (98.1%. n = 206), through Patient Relations (69%, n = 145), or by e-mail (31%, n = 66).

In this prospective cohort multiunit study of parents and staff of CMC, 3 in 7 parents had a safety concern during hospitalization. Nearly 70% were medical errors. Families with less education were less likely to have safety concerns, indicating a potential disparity and an area for improving engagement. Although families frequently had safety concerns during hospitalization, families still rated safety climate items higher than staff. Despite the fact that informing families how to report concerns is a national quality metric, only one-third of families were told by staff how to report mistakes.¹⁴  Our findings suggest that families of hospitalized CMC provide valuable and valid safety information and that hospitals have room to improve how they engage families in safety, particularly those with lower education or other barriers.

Our findings are consistent with prior studies, which show that 9% to 49% of patients/families report safety concerns during hospitalization, most of which are classified as medical errors.^{12,13,24–26}  However, our finding that only 32% of parents were told by staff how to report safety concerns during their child’s hospitalization is even lower than published rates for this single-most-poorly rated Child HCAHPS¹⁴  item across hospitals.²⁷  Our percentage may be lower because staff may assume families of CMC are familiar with hospital processes and neglect to proactively orient them to hospital safety. As in other studies,^12,13,25,28  medications were the most common error type in our study.

CMC are vulnerable to medical errors and AEs due to multiple medications,^5,29–31  malfunctioning indwelling medical devices,⁴  longer LOS,^{13,28,32–35}  frequent readmissions,^36–38  and fragmented communication among multiple providers.^7,30,39  Families of CMC are vigilant partners⁴⁰  in safety—critical members of the care team who can help identify mistakes in medical care and hospital safety. Families of CMC often have strong self-management skills, actively coordinating health care to manage chronic conditions.^41–43  These skills give them particular expertise about their children’s baseline health status, quality of life, medical care, and potential deviations in care plan or changes in health.^44–46  For instance, families of CMC may be particularly attuned to recognizing errors and AEs because they frequently provide specialized medical care (eg, suctioning, enteral feeds) at home and in the hospital.^47,48  Because many CMC are nonverbal, their families may be particularly attuned to subtle changes in status. Families of CMC are consequently effective witnesses to gaps in communication and care delivery across providers, specialties, and facilities.^46,49 

Our study suggests that leveraging family expertise can improve care for patients, individually and collectively. On an individual level, families can notice clinical decompensation and help intercept potential AEs earlier than medical staff. For example, in our study, a family was the first to notice a change in their child’s abdominal exam. While the clinical team initially disregarded the family’s concern, the patient was ultimately diagnosed with intussusception. On a systems level, family input can highlight underrecognized safety vulnerabilities and prioritize quality improvement efforts. For instance, many families in our study reported their child was receiving incorrect home medications, specialized formulas, and durable medical equipment, suggesting these may be particular areas for improvement for hospitalized CMC.

Family safety reporting has value both in real time (to address in-the-moment concerns) and retrospectively (so hospitals can examine and learn from trends to help other patients). In our study, parents verbally expressed concerns to staff, mostly nurses, frequently. However, it is unclear how many family verbal reports to staff were formally documented in VIR considering that staff have competing demands and frequently underutilize VIR,⁵⁰  particularly for no-harm events. The number of family reports captured in VIR is likely low, given so few staff in our study reported entering a VIR in response to family concerns, particularly for “good catches” or no-harm/low-harm events. However, even no-harm/low-harm events have important safety implications. For instance, correcting a home medication omission before it reaches the patient may not lead to harm, but may represent an underlying systems hazard around medication reconciliation that warrants improvement. No-harm events can also erode trust and hospital experience. Excluding family input compromises hospitals’ ability to comprehensively assess potential safety issues and remedies, relegating hospitals to react to issues after they occur rather than proactively prevent them. Providing patients/families a direct, easy route to share safety concerns allows hospitals to more reliably document, track, and identify otherwise unrecognized^{12,13,25,26,28,51}  safety improvement areas that are important to patients/families. This is particularly important for patients/families who may be less likely to speak up because of educational, language, or other barriers.^52–56 

Despite families’ willingness to speak up about hospital safety experiences,^57–59  hospitals often exclude patients/families from VIR and fail to offer clear mechanisms for family safety reporting.⁶⁰  Hospitals can involve patients/families in safety reporting by including families in VIR and creating and utilizing dedicated family safety reporting mechanisms (eg, mobile family reporting tools, patient portals, comment boxes, family safety hotlines). They can also include safety reporting questions in patient experience surveys and have a designated staff member solicit family concerns in person.

Soliciting and meaningfully acting on concerns from patients/families requires additional time and resources for hospitals. This investment is worthwhile, however, because it allows hospitals to improve care in unaddressed areas that are meaningful for families, thereby improving safety and experience. Additionally, families are present and willing to help and represent an existing, underutilized resource to aid in improving safety. Partnership with families around safety also gives families agency and allows them to coproduce health care, a key tenet of patient-/family-centered care.⁶¹  However, if hospitals lack resources, they could alternatively target high-risk populations, like oncology patients and CMC, for family safety reporting.

Although families in our study frequently had safety concerns during hospitalization, they were less likely than staff to report poor safety climate scores. Families appeared to have a more positive view of safety than staff, perhaps because hospitals are not fully transparent with patients/families about safety risks during hospitalization. The National Academy of Medicine writes in To Err is Human that families are often unaware of patient safety risks⁶²  and suggests better educating patients/families about safety as an important impetus for patient safety improvement. Hospitals will have to find ways to be more transparent about patient safety in a forthright but sensitive manner that does not alarm families.

Our study’s limitations include generalizability. We conducted it on a dedicated service for CMC at a tertiary care children’s hospital with predominantly White mothers present at the bedside. We also excluded international patients and parents speaking languages besides Spanish. Data from parents may have also suffered from recall bias and we may have missed events experienced immediately predischarge. When there was insufficient information to classify family concerns, we reviewed patient charts retrospectively, not prospectively, which is another area for future investigation. Physician-reviewers, not parent-reviewers, ultimately classified events. Future studies might include trained parent-reviewers and evaluate the overlap between physician-reviewer and parent-reviewer interpretations of error. Parent and staff surveys were also not linked by patient, an important area for future study. Additionally, while reporting is important, it is only one step of the life cycle of a safety report. Follow-up with the reporter is another important step.⁶³  Investigating follow-up and changes resulting from family reporting are important areas for future study. Ultimately, the intended goal of family safety reporting is to improve systems and invoke actual change, not report merely for the sake of reporting.⁶⁴ 

Families of hospitalized CMC, particularly more educated families, frequently had safety concerns during their child’s hospitalization. Most concerns represented medical errors. Parents often reported concerns to staff, mainly nurses, despite being infrequently told by staff how to report concerns. However, it is unclear how many concerns are entered by staff into VIR. Hospitals should proactively engage families in safety reporting, particularly those with less education and other barriers, to avoid widening disparities. Better engaging all families will allow hospitals to identify safety vulnerabilities and areas for improvement that are otherwise unrecognized and meaningful to families.

We thank the patients, families, and caregivers involved in this project, as well as the research assistants, research clinicians, and unit staff.

AE

adverse event

CCC

complex chronic conditions

CI

confidence interval

CMC

children with medical complexity

HCAHPS

Hospital Consumer Assessment of Healthcare Providers and Systems

IV

intravenous

LOS

length of stay

VIR

voluntary incident reporting/report