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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-intervention arm | No Intervention | This arm is the pre-intervention arm of parents and providers before the family safety reporting bundle has been implemented. | |
| Post-intervention arm | Experimental | This arm is the post-intervention arm of parents and providers after the family safety reporting bundle has been implemented on the study units. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family safety reporting intervention | Behavioral | family safety reporting intervention for families and providers |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alisa Khan, MD, MPH | Boston Children's Hospital/Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-intervention Arm | This arm is the pre-intervention arm of participants before the family safety reporting bundle has been implemented. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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English- and Spanish-speaking parents of hospitalized children with medical complexity (CMC). Baseline data for providers and hospitalized children was not collected because the intervention was being conducted with the families of hospitalized children, and not providers or hospitalized children. Missing data from participants may occur as some participants did not provide all baseline information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-intervention Arm | This arm is the pre-intervention arm of participants before the family safety reporting bundle has been implemented. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We included English/Spanish-speaking parents of patients of all ages hospitalized on the complex care service. | Posted | Count of Participants | Participants | 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. |
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Time on study unit, from admission to discharge, on average approximately 9 days.
Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-intervention Arm | This arm is the pre-intervention arm of participants (families of children with medical complexity) whose children had monitored/assessed adverse events before the family safety reporting bundle had been implemented on the study units. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Events | General disorders | Systematic Assessment | Serious Adverse Events were those that we rated categories G and H using the NCC MERP Index. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Events | Cardiac disorders | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alisa Khan, MD, MPH | Boston Children's Hospital | 6173552565 | alisa.khan@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2023 | Nov 13, 2023 | Prot_SAP_000.pdf |
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pre-post intervention study
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157). | Count of Participants | Participants |
|
| Region of Enrollment | We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157). | Count of Participants | Participants |
|
| English Proficiency | We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157). | Count of Participants | Participants |
|
| Education Attainment | We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157). | Count of Participants | Participants |
|
| Post-intervention Arm |
This arm is the post-intervention arm of parents and providers 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 |
|
|
| 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. | We included English/Spanish-speaking parents of patients of all ages hospitalized on the complex care service. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 0 |
| 232 |
| 0 |
| 232 |
| 14 |
| 232 |
| EG001 | Post-intervention Arm | This arm is the post-intervention arm of participants (families of children with medical complexity) whose children had recorded adverse events after the family safety reporting bundle had been implemented on the study units. | 0 | 208 | 0 | 208 | 23 | 208 |
|
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| Other Adverse Events | Gastrointestinal disorders | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Infections and infestations | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Injury, poisoning and procedural complications | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Musculoskeletal and connective tissue disorders | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Nervous system disorders | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Product Issues | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Renal and urinary disorders | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Skin and subcutaneous tissue disorders | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Other Adverse Events | Surgical and medical procedures | Systematic Assessment | Other Adverse Events were those that we rated categories E and F using the NCC MERP Index. |
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| Black/African-American, non-Hispanic |
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| Hispanic |
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| Multi-racial, non-Hispanic |
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| Other, non-Hispanic |
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| White, non-Hispanic |
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