- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407129
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)
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 Spanish and English 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. After piloting the intervention in one inpatient unit, marked improvements in family safety reporting and reductions in disparities in reporting by parent education and language results. The investigators now propose to conduct an RCT of the intervention in 4 geographically, ethnically, and linguistically diverse hospitals. The specific aims are to: (1) evaluate the effectiveness of the intervention in improving error detection and other safety outcomes, (2) assess the impact of the intervention on disparities in reporting, and (3) understand contextual factors contributing to successful implementation of the intervention. If effective, the intervention will contribute by: (1) increasing patient/family engagement in reporting, especially from vulnerable groups, (2) identifying otherwise unrecognized events, and (3) enabling hospitals to better understand safety problems in a 360-degree manner and design more effective, patient-centered solutions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alisa Khan, MD, MPH
- Phone Number: 6173552565
- Email: alisa.khan@childrens.harvard.edu
Study Contact Backup
- Name: Brynn E Elder, BS
- Phone Number: 8572183233
- Email: Brynn.Elder@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Alisa Khan, MD, MPH
- Phone Number: 617-355-2565
- Email: alisa.khan@childrens.harvard.edu
-
Principal Investigator:
- Alisa Khan, MD, MPH
-
Sub-Investigator:
- Jennifer Baird, PhD, MPH, MSW, RN, CPN
-
Sub-Investigator:
- Hsiang "Shonna" Yin, MD, MS
-
Sub-Investigator:
- Michelle Kelly, MD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient/Family/Caregiver who is hospitalized on the study unit during the study period or hospital employee who works at the study sites
- Primarily English- or Spanish-speaking (other languages pending interpreter/translator resources)
Exclusion Criteria:
- Admitted awaiting inpatient psychiatric placement
- In state custody
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
This arm is the usual care arm of parents and providers who are randomized to proceed with usual care and are not given the family safety reporting intervention.
|
|
Experimental: Experimental: Intervention arm
This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units.
|
Family safety reporting intervention for patients/families
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical errors
Time Frame: From date of randomization through hospital discharge (typically about 7 days).
|
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.
|
From date of randomization through hospital discharge (typically about 7 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital experience
Time Frame: From date of randomization through hospital discharge (typically about 7 days).
|
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.
|
From date of randomization through hospital discharge (typically about 7 days).
|
Hospital safety climate
Time Frame: From date of randomization through hospital discharge (typically about 7 days).
|
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.
|
From date of randomization through hospital discharge (typically about 7 days).
|
Patient/parent patient activation
Time Frame: From date of randomization through hospital discharge (typically about 7 days).
|
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.
|
From date of randomization through hospital discharge (typically about 7 days).
|
Patient/family reported safety concerns concerns
Time Frame: From date of randomization through hospital discharge (typically about 7 days).
|
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.
|
From date of randomization through hospital discharge (typically about 7 days).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient/family-reported areas for safety improvement
Time Frame: From date of randomization through hospital discharge (typically about 7 days).
|
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.
|
From date of randomization through hospital discharge (typically about 7 days).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alisa Khan, MD, MPH, Boston Children's Hospital/Harvard Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB-P00042333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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