Human-centered Injury Thrivorship Pathway for Survivors of Physical Trauma

March 4, 2024 updated by: University of California, San Francisco

Identifying & Addressing Unmet Needs of Injury Survivors at a Safety Net Hospital in San Francisco

The goal of this clinical trial is to pilot and evaluate a human-centered injury thrivorship pathway in injury survivors. The main question it aims to answer is:

• Is the pathway appropriate, acceptable, and feasible to meet the medical and social needs of injury survivors?

Injury survivors will be purposively sampled to enroll in the pathway and asked to participate in in-depth interviews and their use of pathway resources will be tracked.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

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 Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient ≥ 18 years old presenting with a physical injury to Zuckerberg San Francisco General Hospital
  • Admitted to the hospital ≥ 24 hours
  • Discharged from the hospital alive
  • San Francisco resident or unhoused in San Francisco
  • Capacity for informed consent

Exclusion Criteria:

  • Patient < 18 years old
  • Deceased during index hospitalization
  • Unable to provide informed consent

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: Injury Thrivorship Pathway
Enrollment in the human-centered injury thrivorship pathway.
Other: Human-Centered Injury Thrivorship Pathway
Enrollment in the human-centered injury thrivorship pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Implementation Outcomes - Acceptability, Appropriateness, Feasibility
Time Frame: 8-12 weeks post-pathway enrollment
Early implementation outcomes will be assessed via purposive sampling of pathway participants, their caregivers, and trauma care stakeholders for in-depth semi-structured interviews. "Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Appropriateness is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting."
8-12 weeks post-pathway enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant pathway resource utilization - type
Time Frame: 8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant engagement with applicable pathway resources will be tracked by type of resource(s) accessed
8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant pathway resource utilization - frequency
Time Frame: 8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant engagement with applicable pathway resources will be tracked by frequency of use of the resource(s)
8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant pathway resource utilization - duration
Time Frame: 8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant engagement with applicable pathway resources will be tracked by duration of use of the resource(s)
8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant pathway resource utilization - % utilized
Time Frame: 8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year
Participant engagement with applicable pathway resources will be tracked by overall % of resources utilized out of resource(s) offered
8-12 weeks post-pathway enrollment plus subsequent time points if continued resource engagement until study completion up to 1 year

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Marissa A Boeck, MD, MPH, 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 (Estimated)

July 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0555788
  • 2KL2TR001870 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators are undecided how individual participant data will be shared with other researchers, which the investigators will update prior to the initial recruitment date. The primary outcome will be qualitative data from in-depth semi-structured interviews linked to participant demographic and clinical information. The secondary outcome will be quantitative based on resource utilization, also linked to participant demographic and clinical information.

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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