Enhancing the Care Transitions Intervention With Peer Support to Reduce Disparities

NCT04981977 | Active Not Recruiting DMC

• 2 other identifiers: STUDY002687AD-2019C1-16066
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 1

Brief Summary

Unplanned hospital readmissions are extremely costly to patients and our healthcare system. Being readmitted to the hospital also leads to increased risk of health complications for patients including infections and impairments in functioning. Hospital readmissions are particularly common among older adults. Further, racial/ethnic disparities are evident in readmission rates and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable, and culturally appropriate interventions to improve outcomes, reduce unplanned hospital readmissions, and reduce health disparities are urgently needed. The proposed randomized controlled trial will evaluate the effectiveness of a novel transitional care strategy designed to avoid unplanned hospital readmissions and improve patient health outcomes in a racially/ethnically diverse sample of older adults who have been admitted to the hospital due to a chronic health condition. Eric Coleman's Care Transitions Intervention (CTI) has been identified as the strategy most successfully implemented and evaluated in multiple settings and systems of care. CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however its' effects have not been as strong for minority older adults in some studies and research trials have not recruited a sufficient number of racial/ethnic minorities to examine outcomes by race or ethnicity. Thus, it is unknown whether CTI is effective for racial/ethnic minority older adults who suffer disproportionately high readmission rates. Further, studies of transitions interventions suggest that older adult and racial/ethnic minority patients require additional assistance and support during transitions in care. The researchers hypothesize the addition of peer support will enhance and maximize the benefit of the CTI and increase its' cultural sensitivity and future sustainability. The proposed 3-arm trial is designed to evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), as compared to usual care (UC), on unplanned all-cause hospital readmissions occurring within 6 months (assessed at 30 days, 90 days and 6 months) and secondary health system (i.e., ED visits) and patient-centered outcomes (i.e., self-efficacy managing chronic disease, quality of life, functional status and mortality) among 402 hospitalized African American and Latino/Hispanic older adults (age 60+) who have a chronic physical illness (e.g., cardiovascular disease, diabetes, COPD) and are being discharged from the hospital back to the community.

Conditions

Hospital Readmissions

Outcome Measures

Primary Outcomes (6)

• Unplanned All-Cause Hospital Readmissions

  The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).

  30 days

• Unplanned All-Cause Hospital Readmissions

  The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HI

  Three months

• Unplanned All-Cause Hospital Readmissions

  The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HI

  Six months

• Related Secondary Health-System Visits (i.e., ED Visits)

  The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).

  30 days

• Related Secondary Health-System Visits (i.e., ED Visits)

  The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).

  Three months

• Related Secondary Health-System Visits (i.e., ED Visits)

  The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).

  Six months

Secondary Outcomes (22)

• Demographic Questionnaire

  At time of enrollment/Baseline

• Care Transitions Measure (CTM-3)

  30 days

• Care Transitions Measure (CTM-3)

  Three months

• Care Transitions Measure (CTM-3)

  Six months

• Self-Efficacy (SES-6)

  Baseline

Study Arms (3)

Care Transitions Intervention

EXPERIMENTAL

Patient participants in this arm will receive the Care Transition Intervention.

Behavioral: Care Transitions Intervention

Care Transition Intervention and Peer Support

EXPERIMENTAL

Patient participants in this arm will receive the Care Transition Intervention.

Behavioral: Care Transitions Intervention and Peer Support

Usual Care

OTHER

Patient participants in this arm will receive the usual discharge/transition care provided by the hospital.

Other: Usual Care

Interventions

Care Transitions Intervention and Peer Support BEHAVIORAL

The PS intervention for this study is based upon the principles of motivational interviewing, which is a person-centered, goal-directed method to enhance intrinsic motivation for change by exploring and resolving ambivalence. A recent meta-analysis found the mean effect size for MI to be significantly larger for racial and ethnic minority samples (0.79 vs. 0.26) as compared to non-Hispanic Whites, highlighting its potential benefit and cultural relevance for minority populations. Patients in this arm of the study will receive the 28-day CTI intervention with a 2-month long Peer Support (PS) intervention provided by trained peer educators (PEs).

Also known as: CTI + PS

Care Transition Intervention and Peer Support

Care Transitions Intervention BEHAVIORAL

CTI is delivered by a trained Care Transitions Coach (Coach) who works closely with patients to ensure a smooth transition from hospital to home following an acute hospitalization. The patient, caregiver, and Coach work together to maximize the involvement of interdisciplinary experts, ensuring that the appropriate professionals are involved, issues are addressed, goals are understood, and the discharge care plan is executed correctly. There are three aspects to CTI; the first is the initial hospital visit, followed by an in-home visit, concluding with telephone follow-up over a 28-day period. During these visits, the Coach focuses on four conceptual areas, referred to as pillars (i.e., Personal Health Record, Medication Management, Red Flags, and Physician Follow up). The Coach ensures the patient understands and utilizes the Personal Health Record to facilitate communication and ensure continuity of care plan across providers and settings.

Also known as: CTI

Care Transitions Intervention

Usual Care OTHER

The researchers will follow a control group of patients who meet study inclusion criteria. These older adults will participate in the traditional discharge case-management offered by the hospital where they were admitted and discharged. UC at our three partner hospitals consists of: (1) routine inpatient nurse intake that includes screening about housing, substance abuse, and functional status; (2) medication reconciliation performed by treating practitioners; (3) discharge patient education provided by inpatient nurses; (4) a list of resources for safety-net clinics and community-based services; and (5) for patients with severe chronic illness (e.g. heart failure) there may be a planned home visit by a nurse practitioner.

Also known as: UC

Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient participants (N=402) will be included in the study if they:
• Are aged 60+
• Identify as African American or Latino/Hispanic (any race)
• Are being discharged from one of our three hospital partners to home with no planned readmissions
• Have access to a household telephone or cellphone
• Speak English or Spanish

You may not qualify if:

• Patient participants will be excluded from the study if they:
• Are younger than age 60
• Identify as any race/ethnicity other than African American or Latino/Hispanic
• Are being discharged with a condition that has planned readmission (e.g. transplant patient, chemotherapy etc.)
• Are permanent residents of a skilled nursing facility, receiving hospice service, or are being discharged to a long-term care facility
• Have a comorbid substance use disorder
• Are actively suicidal or homicidal
• Have a comorbid psychotic disorder or organic mental disorder (e.g., dementia)

Sponsors & Collaborators

• University of South Florida: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Tampa General Hospital: collaborator
• Lakeland Regional Health Medical Center: collaborator
• AdventHealth: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Study Officials

• Amber M Gum, Phd

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: May 19, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (1)