Family Reported Errors and Adverse Events
Conditions
Brief summary
Miscommunications are a leading cause of serious medical errors in hospitals, contributing to more than 60% of sentinel events, the most serious adverse events reported to the Joint Commission. Efforts to improve patient safety in hospitals have centered on improving communication between providers. While provider-focused communication interventions have led to reductions in patient harm, patients and families have been notably absent from most interventions to improve patient safety. This proposal seeks to develop a family safety reporting intervention.
Interventions
BEHAVIORALFamily safety reporting intervention
family safety reporting intervention for families and providers
Sponsors
Boston Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
pre-post intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Primary caregiver of a child hospitalized on the study units during the study period or hospital employee who works on the study unit(s) * Country of Origin: United States * Primarily English- or Spanish-speaking
Exclusion criteria
* International patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family Safety Reporting Rates | During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days. | Our primary outcome was family-reported safety concerns, defined as reporting safety concern(s) via pre-discharge survey (baseline and intervention) or mobile tool (intervention). Safety concerns were counted once if reported both via survey and mobile tool. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Reported Hospital Safety Climate Scores | During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days. | For Family Reported Hospital Safety Climate Scores, Child HCAHPS safety experience was used to ask whether hospital staff told participants how to report concerns about mistakes. We examined top-box (top-most, e.g., 5 of 5, Likert scale) safety climate scores baseline vs intervention and proportion of parents reporting yes definitely or yes somewhat vs no to the Child HCAHPS tell you how to report question. |
Countries
United States
Participant flow
Pre-assignment details
The protocol enrollment reflects participants who are families of hospitalized children and providers among the hospital units. The Participant Flow reflects only families of hospitalized children that participated in the mobile tool aspect of the intervention, which the Providers group did not participate in and therefore are not included here.
Participants by arm
| Arm | Count |
|---|---|
| Pre-intervention Arm This arm is the pre-intervention arm of participants before the family safety reporting bundle has been implemented. | 207 |
| Post-intervention Arm This arm is the post-intervention arm of participants after the family safety reporting bundle has been implemented on the study units.
Family safety reporting intervention: family safety reporting intervention for families and providers | 157 |
| Total | 364 |
Baseline characteristics
| Characteristic | Post-intervention Arm | Total | Pre-intervention Arm |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 10 | 46 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 11 |
| Education Attainment Completed college or higher | 70 Participants | 171 Participants | 101 Participants |
| Education Attainment Less than college | 85 Participants | 190 Participants | 105 Participants |
| English Proficiency Limited English Proficient | 22 Participants | 53 Participants | 31 Participants |
| English Proficiency Proficient | 132 Participants | 306 Participants | 174 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native, Non- Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander, non-Hispanic | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Black/African-American, non-Hispanic | 9 Participants | 18 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 34 Participants | 64 Participants | 30 Participants |
| Race/Ethnicity, Customized Multi-racial, non-Hispanic | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Other, non-Hispanic | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 105 Participants | 257 Participants | 152 Participants |
| Region of Enrollment United States | 157 Participants | 364 Participants | 207 Participants |
| Sex: Female, Male Female | 134 Participants | 302 Participants | 168 Participants |
| Sex: Female, Male Male | 21 Participants | 58 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 232 | 0 / 208 |
| other Total, other adverse events | 14 / 232 | 23 / 208 |
| serious Total, serious adverse events | 0 / 232 | 0 / 208 |
Outcome results
Primary
Family Safety Reporting Rates
Our primary outcome was family-reported safety concerns, defined as reporting safety concern(s) via pre-discharge survey (baseline and intervention) or mobile tool (intervention). Safety concerns were counted once if reported both via survey and mobile tool.
Time frame: During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days.
Population: We included English/Spanish-speaking parents of patients of all ages hospitalized on the complex care service.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-intervention Arm | Family Safety Reporting Rates | 61 Participants |
| Post-intervention Arm | Family Safety Reporting Rates | 60 Participants |
Secondary
Family Reported Hospital Safety Climate Scores
For Family Reported Hospital Safety Climate Scores, Child HCAHPS safety experience was used to ask whether hospital staff told participants how to report concerns about mistakes. We examined top-box (top-most, e.g., 5 of 5, Likert scale) safety climate scores baseline vs intervention and proportion of parents reporting yes definitely or yes somewhat vs no to the Child HCAHPS tell you how to report question.
Time frame: During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days.
Population: We included English/Spanish-speaking parents of patients of all ages hospitalized on the complex care service.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-intervention Arm | Family Reported Hospital Safety Climate Scores | 66 Participants |
| Post-intervention Arm | Family Reported Hospital Safety Climate Scores | 69 Participants |