Family Input for Quality and Safety (FIQS)

October 24, 2018 updated by: University of California, San Francisco

Novel IT to Create Patient-Integrated Hospital Quality Improvement and Improve Patient Safety

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Benioff Children's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
After completing enrollment surveys, including measures of patient activation and medical knowledge, participants will be invited to use the novel IT. The technology is a mobile responsive website for survey data collection made by our technology vendor, QuesGen. Patients and family members will be able to access the website from any personal device with internet access: laptop, tablet, or smart phone. QuesGen will send a text message reminder to participants with a link to specific questionnaires at scheduled time intervals. Frequency of text messaging will likely be daily, but will ultimately reflect family and patient feedback in Aim 1. In addition to text reminders, participants will be able to answer questionnaires at-will by accessing the mobile responsive website.
Behavioral: Intervention
QuesGen-created mobile responsive website tool, Family Input for Quality and Safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in rate of preventable medical errors or adverse events per 100 admissions
Time Frame: 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).
This is a hospital unit-level outcome measure, assessing unit-level rate of adverse events and preventable medical errors in a time period before the intervention, and the unit-level rate at the end of the intervention. The investigators will apply standard definitions of medical errors as preventable failures in processes of care and adverse events as preventable and non-preventable unintended consequences of medical care that lead to patient harm. This is a composite measure and will be measured as total count of medical errors plus total count of adverse events per 100 admissions. The investigators will not track this measure across the same group of patients in the before and after periods. Participants will be included for the duration of their admission, which may vary. The rate will be measured cross-sectionally in both time periods.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Naomi Bardach, MD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FIQS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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