Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203509
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-01-02
Brief Title:
Improving Care Transitions for Medicaid Insured Individuals With Co-occurring Serious Mental Illness
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
An Equity-focused Intervention to Improve Care Transitions for Medicaid Insured Individuals With Co-occurring Chronic Medical Conditions and Serious Mental Illness
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THRIVE-SMI
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 clinicianadministrator perspectives on the pathways 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
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 interventions 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 interventions 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 THRIVEs implementation and outcomes
Qualitative Study
The recruitment process is meticulously managed to track each participants 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 interventions rollout and its impact on patient care and outcomes
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 interventions 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 interventions 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 THRIVEs implementation and outcomes
Qualitative Study
The recruitment process is meticulously managed to track each participants 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 interventions rollout and its impact on patient care and outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R18HS029815-01 | AHRQ | None | httpsreporternihgovquickSearch1R18HS029815-01 |