Clinical trial NCT05714605: Implementation and Evaluation of A Health Innovation to Support Medicaid-Insured Individuals Following Hospitalization
Official title: Implementation and Evaluation of THRIVE: A Health Innovation to Support Care Transitions for Medicaid-Insured Individuals Following Hospitalization
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Care Transitions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Rita & Alex Hillman Foundation
First posted: 2023-02-06
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Referrals to Homecare
timeFrame: Through study completion, an average of 18 months
measure: Rates of Readmissions
timeFrame: 30 days following hospital discharge
measure: Rates of Emergency Department Visit
timeFrame: 30 days following hospital discharge
measure: Primary Care or Specialist Visit
timeFrame: 30 Days following hospital discharge
Secondary outcomes:
measure: Feasibility, Acceptability, Appropriateness, Workload
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Margo B Brooks Carthon, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: