Clinical trial NCT06203509: Improving Care Transitions for Medicaid Insured Individuals With Co-occurring Serious Mental Illness
Official title: An Equity-focused Intervention to Improve Care Transitions for Medicaid Insured Individuals With Co-occurring Chronic Medical Conditions and Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Care Transitions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-01-12
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the THRIVE clinical pathway at HUP-Cedar, 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. To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness.
2. To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care.

Participants will be referred to home care services during hospitalization and seen by a home care nurse within 48 hours post-discharge. A discharging physician or Advanced Practice Provider will oversee care for 30 days or until a primary care or specialist visit. The Care Coordination Team will hold weekly case conferences for 30 days post-discharge to address both health and mental health needs. The study will compare outcomes of Medicaid-insured patients, including those with serious mental illness, to those receiving usual care.

Detailed description: Detailed Description:

This study is a single-site Type 1 hybrid effectiveness-implementation parallel mixed methods (quantitative + qualitative) quasi-experimental study at HUP-Cedar, focusing on the THRIVE clinical pathway. It integrates simultaneous quantitative and qualitative data collection and analysis, with a stronger emphasis on quantitative data to evaluate referrals, outcomes, and program fidelity. The qualitative aspect will explore the implementation process, delving into the barriers and facilitators encountered by healthcare providers. It will also assess stakeholder perspectives on the intervention's impact on health inequities among Medicaid-insured individuals in both acute and home care settings. By nesting qualitative interviews within a quasi-experimental framework, the study aims to examine the intervention's effect on primary outcomes (homecare referrals, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to its implementation. The combination of effectiveness data with contextual insights will inform understanding of factors critical to THRIVE's implementation and outcomes.

Qualitative Study:

The recruitment process is meticulously managed to track each participant's journey. Recruitment begins in early January, with participants contacted via email, providing study details and interview scheduling links. Follow-up reminders ensure participant engagement. Interviews, conducted virtually and recorded with consent, focus on maintaining confidentiality and privacy. Non-consented sessions are captured through detailed notes. Post-interview, recordings are transcribed for analysis, enabling categorization into codes and themes for a deeper understanding of participant perspectives.

Quantitative Study:

Employing a stepped wedge design, the study would begin early March and would involve a randomized training of case managers at HUP-Cedar over several months. Initially, a subset of case managers receives training on the THRIVE pathway and starts offering referrals. After 8 weeks, the remaining case managers are trained and begin making referrals. This staggered approach allows for evaluation of the THRIVE intervention's rollout and its impact on patient care and outcomes.

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: Upenn School of Nursing Centre For Health Outcomes Policy Research
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jacqueline M Brooks Carthon, PhD,RN
role: PRINCIPAL_INVESTIGATOR
References: