RECRUITING

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)

Quick Facts

Study Start:2023-04-13
Study Completion:2028-10-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05407129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Participants speaking all languages are eligible
  1. * Admitted awaiting inpatient psychiatric placement
  2. * In state custody
  3. * Admitted for greater than 24 hours
  4. * Same day discharge
  5. * Covid positive
  6. * Previously enrolled in I-SHARE
  7. * Airborne illness precautions

Contacts and Locations

Study Contact

Alisa Khan, MD, MPH
CONTACT
6173552565
alisa.khan@childrens.harvard.edu
Monica Soni, BA
CONTACT
8572183233
monica.soni@childrens.harvard.edu

Principal Investigator

Alisa Khan, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital/Harvard Medical School

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Alisa Khan, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital/Harvard Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13
Study Completion Date2028-10-28

Study Record Updates

Study Start Date2023-04-13
Study Completion Date2028-10-28

Terms related to this study

Additional Relevant MeSH Terms

  • Family Reported Errors and Adverse Events
  • Health Disparities
  • Family Safety Reporting
  • Patient Safety
  • Voluntary Incident Reporting
  • Quality Improvement