Implementation and Evaluation of A Health Innovation to Support Medicaid-Insured Individuals Following Hospitalization

NCT ID: NCT05714605

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this stepped wedge pragmatic trial is to compare referral patterns and post discharge outcomes in Medicaid insured individuals discharge following a hospitalization\]. The aims are to 1) evaluate the implementation of the THRIVE clinical pathway, including feasibility, appropriateness, and acceptability and 2) examine referral patterns, 30- day readmission and Emergency Department (ED) utilization patterns for participants who receive THRIVE support services. During hospitalization participants will receive a referral to home care services and will be seen by a home care nurse within 48 hours following discharge. A discharging physician or Advanced Practice Provider will maintain clinical oversight for 30 days or until the patient sees primary care provider or specialist. A Care Coordination Team conducts weekly case conferences to ensure social and health needs are being addressed for 30 days post-discharge. Researchers will compare Medicaid insured patients discharged during the study, to those receiving usual care to determine if there are differences in post-acute utilization outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective single site Type 1 hybrid effectiveness-implementation parallel mixed methods (QUANT + qual) quasi-experimental study. This study design involves simultaneous collection and analysis of quantitative and qualitative data, giving priority weight to the quantitative data to evaluate program referrals, outcomes, and program fidelity, while qualitative data will evaluate process through detailed descriptions of perspectives of barriers and facilitators faced by health care providers in implementing the THRIVE intervention. Qualitative interviews will also assess stakeholder perspectives of the value of the intervention in addressing health inequities among Medicaid insured individuals cared for in the acute and home care settings. Nesting the qualitative interview within a single-site randomized trial of a the THRIVE intervention will allow us to determine whether the intervention improved primary outcomes (referrals to homecare, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to implementation. Combining these insights with that of effectiveness outcome date will allow consideration for meaningful contextual factors that are viewed as critical to the implementation of THRIVE and subsequent outcomes. Our stepped wedge design with include a randomized roll-out to case managers at Pennsylvania Hospital and the study will be carried out over 18 months. To begin, 5 case managers will be randomized to receive training on the THRIVE clinical pathway. Following training they will be invited to begin offering referrals to the THRIVE clinical pathway. After 2 months the remaining 4 case managers will be trained on the THRIVE intervention and will be able to begin submitting referrals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Care Transitions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

THRIVE Intervention

1 month intensive post discharge case management and care coordination.

Group Type EXPERIMENTAL

THRIVE Intervention

Intervention Type BEHAVIORAL

The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals following hospitalization.

Usual Care

Discharge to home without intensive post acute case management or care coordination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

THRIVE Intervention

The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals following hospitalization.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Medicaid insured
* Residing in the state of Pennsylvania
* Experienced a hospitalization at study hospital
* Agrees to home care at partner home care setting.

Exclusion Criteria

* Individuals under age 18
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rita & Alex Hillman Foundation

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margo B Brooks Carthon, PhD RN

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Brooks Carthon JM, Brom H, Grantham-Murrillo M, Sliwinski K, Mason A, Roeser M, Miles D, Garcia D, Bennett J, Harhay MO, Flores E, Amenyedor K, Clark R. Equity-Centered Postdischarge Support for Medicaid-Insured People: Protocol for a Type 1 Hybrid Effectiveness-Implementation Stepped Wedge Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 26;13:e54211. doi: 10.2196/54211.

Reference Type DERIVED
PMID: 38530349 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10080229

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Implementation of Suicide Risk Models in Health Systems
NCT06060535 ENROLLING_BY_INVITATION NA