NCT06203509

Brief Summary

This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. The study will assess clinician/administrator perspectives on the pathway's feasibility, appropriateness, and acceptability and analyze referral patterns and post-discharge outcomes. The objectives are:

  1. 1.To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness.
  2. 2.To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care.

Trial Health

77
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
5mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress84%
Apr 2024Oct 2026

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

January 2, 2024

Last Update Submit

April 28, 2026

Conditions

Care Transitions

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

THRIVE Intervention 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

Thrive InterventionBEHAVIORAL

• The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals being managed for both chronic diseases and serious mental illness following hospitalization.

THRIVE Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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)

Upenn School of Nursing Centre For Health Outcomes Policy Research

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (2)

  • Brooks Carthon JM, Tibbitt C, Amenyedor KE, Bettencourt AP, Babe E, Cacchione PZ, Brom H. Pre-Implementation Strategies to Support Adaptation of Thrive: A Care Transitions Model for Economically Disadvantaged Patients with Serious Mental Illness. Nurs Rep. 2024 Dec 2;14(4):3803-3818. doi: 10.3390/nursrep14040278.

    PMID: 39728639DERIVED

  • Brooks Carthon JM, Brom H, Amenyedor KE, Harhay MO, Grantham-Murillo M, Nikpour J, Lasater KB, Golinelli D, Cacchione PZ, Bettencourt AP. Transitional Care Support for Medicaid-Insured Patients With Serious Mental Illness: Protocol for a Type I Hybrid Effectiveness-Implementation Stepped-Wedge Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 12;13:e64575. doi: 10.2196/64575.

    PMID: 39531274DERIVED

Study Officials

  • Jacqueline M Brooks Carthon, PhD,RN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline M Brooks Carthon, PhD,RN

CONTACT

2158988050jmbrooks@nursing.upenn.edu

Erin Babe, MPH

CONTACT

2158984417erinbabe@nursing.upenn.edu

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 2, 2024

First Posted

January 12, 2024

Study Start

April 15, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)