Family Reported Errors and Adverse EventsI-SHARENCT05407129
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
A study testing Family safety reporting intervention in people with Family Reported Errors and Adverse Events and Health Disparities, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Reported Errors and Adverse Events, Health Disparities, Family Safety Reporting
- What is being tested?
- Family safety reporting intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 28 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Admitted awaiting inpatient psychiatric placement
- In state custody
- Admitted for greater than 24 hours
- Same day discharge
- Covid positive
- Previously enrolled in I-SHARE
- Airborne illness precautions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Alisa Khan, MD, MPH, 617-355-2565, alisa.khan@childrens.harvard.edu
Alisa Khan, MD, MPH
About this study
Official title: 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 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.
Read the detailed description
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. Our application has high potential to reshape paradigms for measuring and improving safety and equity.
Hypothesis 1A: The I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).
Hypothesis 1B: In the I-SHARE arm, rates of errors detected by the I-SHARE tool will exceed rates detected through VIR.
Hypothesis 1C: The I-SHARE arm will have higher safety experience, safety climate, and patient activation scores than usual care.
Hypothesis 2A: Among Spanish-speaking and less educated patients/families, the I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).
Hypothesis 2B: In the I-SHARE arm, Spanish-speaking and less educated patients/families will report equal rates of errors as English-speaking and more educated patients/families (via I-SHARE tool).
- Conditions
- Family Reported Errors and Adverse Events, Health Disparities, Family Safety Reporting, Patient Safety, Voluntary Incident Reporting, Quality Improvement
- Being tested
- Family safety reporting intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family safety reporting interventionBehavioural
Family safety reporting intervention for patients/families
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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: Intervention arm | Experimental | This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units. Receives: Behavioral: Family safety reporting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization through hospital discharge (typically about 7 days).
Secondary outcomes (4)
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.
Measured: From date of randomization through hospital discharge (typically about 7 days).
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.
Measured: From date of randomization through hospital discharge (typically about 7 days).
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.
Measured: From date of randomization through hospital discharge (typically about 7 days).
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.
Measured: From date of randomization through hospital discharge (typically about 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start13 Apr 2023
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Reported Errors and Adverse EventsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Pediatric Research in Inpatient Settings (PRIS)
- Responsible party
- Principal investigator, Alisa Khan, Boston Children's Hospital
- Investigators
- Alisa Khan, MD, MPH, Principal investigator, Boston Children's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407129
- Sponsor's protocol ID
- IRB-P00042333
- Acronym
- I-SHARE
- Status last verified
- Mar 2026
- First submitted
- 31 May 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)
- ClinicalTrials.gov ID
- NCT05407129
- Acronym / sponsor ID
- I-SHARE / IRB-P00042333
- Conditions
- Family Reported Errors and Adverse Events, Health Disparities, Family Safety Reporting, Patient Safety, Voluntary Incident Reporting, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Pediatric Research in Inpatient Settings (PRIS)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Oct 2028 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Our application has high potential to reshape paradigms for measuring and improving safety and equity.
Hypothesis 1A: The I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).
Hypothesis 1B: In the I-SHARE arm, rates of errors detected by the I-SHARE tool will exceed rates detected through VIR.
Hypothesis 1C: The I-SHARE arm will have higher safety experience, safety climate, and patient activation scores than usual care.
Hypothesis 2A: Among Spanish-speaking and less educated patients/families, the I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).
Hypothesis 2B: In the I-SHARE arm, Spanish-speaking and less educated patients/families will report equal rates of errors as English-speaking and more educated patients/families (via I-SHARE tool).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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: Intervention arm | Experimental | Behavioral: Family safety reporting interventionThis arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Admitted awaiting inpatient psychiatric placement
- In state custody
- Admitted for greater than 24 hours
- Same day discharge
- Covid positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family safety reporting interventionFamily safety reporting intervention for patients/families | Behavioural | Experimental: Intervention arm |
Primary outcome
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.
4 secondary outcomes
Hospital experience
Time frame: 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).
Patient/parent patient activation
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alisa Khan, MD, MPH principal investigator
Boston Children's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family safety reporting intervention in people with Family Reported Errors and Adverse Events and Health Disparities, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisa Khan, MD, MPH (6173552565, alisa.khan@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical errors (time frame: From date of randomization through hospital discharge (typically about 7 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.