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

Care Transitions Clinical Trial

Official title:

Implementation and Evaluation of THRIVE: A Health Innovation to Support Care Transitions for Medicaid-Insured Individuals Following Hospitalization

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05714605
• Other study ID #: 10080229
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 267
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Care Transitions

Intervention

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

Locations

Country	Name	City	State
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Rita & Alex Hillman Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	Feasibility, Acceptability, Appropriateness, Workload	We will conduct interviews of clinicians at the conclusion of the study to gather perceptions of the THRIVE clinical pathway and facilitators and barriers to engaging with the intervention.	Through study completion, an average of 18 months