NCT05714605

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Mar 2023Jun 2026

First Submitted

Initial submission to the registry

January 19, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

January 19, 2023

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Rates of Referrals to Homecare

    We will evaluate changes in home care referrals between case managers exposed to the intervention compared to those who were not.

    Through study completion, an average of 18 months

  • Rates of Readmissions

    We will evaluate the rate of readmissions over the course of the study for THRIVE participants compared to those receiving usual care.

    30 days following hospital discharge

  • Rates of Emergency Department Visit

    We will evaluate the rate of ED visits over the course of the study for THRIVE participants compared to those receiving usual care.

    30 days following hospital discharge

  • Primary Care or Specialist Visit

    We will compare the rates of primary care provider and specialist visits within 30 days following discharge compared to those receiving usual care.

    30 Days following hospital discharge

Secondary Outcomes (1)

  • Feasibility, Acceptability, Appropriateness, Workload

    Through study completion, an average of 18 months

Study Arms (2)

THRIVE Intervention

EXPERIMENTAL

1 month intensive post discharge case management and care coordination.

Behavioral: THRIVE Intervention

Usual Care

NO INTERVENTION

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

Interventions

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

THRIVE Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Individuals under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Margo B Brooks Carthon, PhD RN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 6, 2023

Study Start

March 27, 2023

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations