Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBoston Children's Hospital

About this trial

Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include patients and families in safety reporting and instead relying on flawed VIR presents an important missed opportunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital leaders, investigators created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. The intervention includes 3 elements: (1) a multilingual mobile (email, text, and QR-code) reporting tool prompting families to share concerns and suggestions about safety, (2) family/staff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient/Family/Caregiver who has been hospitalized on the study unit during the study period (within the past 24 hours) or hospital employee who works at the study sites

Participants speaking all languages are eligible

Disqualifiers

Admitted awaiting inpatient psychiatric placement

In state custody

Admitted for greater than 24 hours

Same day discharge

Trial design

Design model

Parallel

Treatments tested in this trial

  • Family safety reporting intervention

    Behavioral

    Family safety reporting intervention for patients/families

Treatment groups

656 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: Experimental: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Medical errors

Investigators will evaluate rates and types of errors detected through the mobile tool and through voluntary incident reporting (VIR). Errors will be validated by physician and chart review in real time using an established process the study team has used in prior studies.

Time frame
From date of randomization through hospital discharge (typically about 7 days).

Secondary outcomes

1

Hospital experience

Measured through the Child HCAHPS survey administered prior to discharge. This survey assesses the experience of pediatric patients. It is available in English and Spanish. Particular items of interest include the "preventing mistakes and helping you report concerns" composite measure, which was the single-lowest rated item across hospitals during field testing. This survey consists of closed-ended and Likert scale items. It was developed by the Center of Excellence for Pediatric Quality Measurement at Boston Children's Hospital with funding from AHRQ, CMS, and CHIPRA. The "helping you report" item is assessed on a 3-point scale, with response options of "No," "Yes, somewhat," and "Yes, definitely," with "Yes, definitely" being the best option.

Time frame
From date of randomization through hospital discharge (typically about 7 days).
2

Hospital safety climate

Measured through the Children's Hospital administered prior to hospital discharge Safety Climate Questionnaire (Cox et al. 2013), which contains 14 questions related to parent perceptions of hospital safety climate. Questions were adapted from the AHRQ Hospital Survey on Patient Safety Culture. The survey consists of Likert-scale items and was validated using confirmatory factor analysis. Domains include overall perceptions of safety, staff communication openness, parent communication openness,and handoffs and transitions. This survey is included as a QualityTool in the AHRQ's Health Care Innovations Exchange. Scales range from Strongly Agree to Strongly Disagree (1-5), with Strongly Agree being the best option, except for reverse-coded items, for which Strongly Disagree is the best option.

Time frame
From date of randomization through hospital discharge (typically about 7 days).
3

Patient/parent patient activation

Measured through the PAM (Patient Activation) administered prior to hospital discharge Measure) and the P-PAM (Parent-Patient Activation Measure) to participants. These surveys measure individuals' knowledge, skills, and confidence ("patient activation") in managing their well-being. The 13-item P-PAM was adapted from the PAM measure and is available in English and Spanish and has acceptable validity and reliability in both English and Spanish. The PAM was developed using qualitative methods, Rasch analysis, and test theory psychometric methods. Items on the measure form a unidimensional, probabilistic, Guttman-like scale. Scales range from Strongly Disagree to Strongly Agree (1-4), with Strongly Agree being the best option.

Time frame
From date of randomization through hospital discharge (typically about 7 days).
4

Patient/family reported safety concerns concerns

Will use data from the family safety reporting tool to analyze the percentage of enrolled patient/families that report through the tool. This will allow the team to understand uptake and compare patient/safety reporting among Spanish-speakers vs English-speakers and less educated vs more educated participants enrolled in the intervention arm.

Time frame
From date of randomization through hospital discharge (typically about 7 days).

Other outcomes

1

Patient/family-reported areas for safety improvement

This qualitative outcome is based on a content analysis of patient/family safety reports to identify themes and areas for improvement in real-time that can be shared with the unit and hospital to improve safety.

Time frame
From date of randomization through hospital discharge (typically about 7 days).

Sponsors and contacts

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Boston Children's Hospital

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Pediatric Research in Inpatient Settings (PRIS)

Collaborator