Clinical trial NCT03202888: Family Input for Quality and Safety
Official title: Novel IT to Create Patient-Integrated Hospital Quality Improvement and Improve Patient Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 435
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool. The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. This will test the hypothesis that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time. The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors.

Detailed description: More than a decade after the seminal Institute Of Medicine report, "To Err is Human", failure rates in patient safety remain stubbornly high in hospitals. Prior efforts to improve hospital quality have had relatively little impact, in part due to limited access to timely quality improvement data. The long-term goal of this application is to leverage existing technologies to give voice to hospitalized patients and their family members, leading to improvements in hospital safety and quality. The overall objective in this application is to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. The central hypothesis, based on the theory of co-production, is that observations from patients and families, gathered in a structured way, will provide actionable information regarding patient safety and quality. The rationale for doing this project is to test an innovative new approach to creating a rapidly available data stream to providers who are working on specific improvement efforts, and a mechanism for creating a quality improvement approach that is inherently patient-centered. The investigators plan to test the central hypothesis and thereby accomplish the objective of this application by focusing on the following areas of research for Health IT: Use, Implementation, and Impact on Outcomes, under the study type "Pilot and feasibility", pursuing three specific aims: Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool (Use and Implementation). The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. The investigators hypothesize that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time (Implementation). The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors (Impact on outcomes). The proposed research is innovative, in the investigators' opinion, based on a paradigm-shifting conceptual model of patient-engaged quality improvement, and because it leverages technology to gather and present data in an unprecedented manner. The expected contribution of the proposed research will be an adapted tool that will gather meaningful and important data on patient safety and present it in an actionable way to providers and hospital leaders, resulting in a powerful data stream to fuel rapid improvements in patient safety. Pilot data from this proposal will inform the design of a future cluster-randomized trial of the new tool across multiple hospital systems. This contribution will be significant because it represents key steps towards a new approach to improving patient safety in the hospital.

Eligibility criteria: Inclusion Criteria:

* Patient and caregiver participants will be recruited from admitted patients and their family members on the medical-surgical units at UCSF's Benioff Children's Hospital during the study period.
* Eligible providers will be the participating hospitalists during the study period.

All nurse managers on the units and the patient safety and quality managers for the units will be eligible. All nurses will be eligible on the participating units.

Exclusion Criteria:

* Patients who are youth in the foster care system will not be eligible.
* Patients or parents/guardians who do not have smart phones will not be eligible.

There are no provider or nurse or quality manager exclusions.

Primary outcomes:
measure: Change in rate of preventable medical errors or adverse events per 100 admissions
timeFrame: Measured cross-sectionally in the hospital unit at baseline for three months, and again for three months at the end of the intervention (months 10,11,12 of the intervention).
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Naomi Bardach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
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