Enhancing the Care Transitions Intervention With Peer Support to Reduce Disparities

NCT ID: NCT04981977

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 483 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2025-07-31

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.

Detailed Description

Unplanned hospital readmissions represent a critical failure of the healthcare system, perpetuate health disparities, and are the single largest driver of excess healthcare costs. For patients, hospital readmission increases risk for complications, infections, and functional impairment. Hospital readmissions are particularly prevalent among older adults. Further, racial/ethnic disparities in readmission rates are profound and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable and culturally appropriate interventions to improve outcomes, reduce un-planned 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 avert un-planned hospital readmissions and improve patient health outcomes in a high-risk and under studied population of medically hospitalized African American and Latino/Hispanic older adults (age 60+). Transitional care strategies are interventions initiated before hospital discharge with the aim of ensuring the safe and effective transition of patients from the acute hospital setting to home. Of all the transitional care interventions tested, 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 is a non-clinical coaching strategy that occurs in the hospital, home, and via telephone for 28 days post-discharge.

CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however intervention effects have been mixed for minority older adults and effectiveness trials have not recruited a sufficient number of racial/ethnic minorities to examine race or ethnicity specific outcomes. Thus, it is unclear 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. To address this gap, the researchers propose to add peer support (PS) to the CTI to enhance its effectiveness among high-risk populations of racial/ethnic minority older adults. The researchers believe 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 all cause unplanned 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. The researchers will also maximize the uniquely diverse sample to explore potential mediators and moderators of intervention effects. The researchers will further conduct semi-structured interviews with patients (n=48) and caregivers (n=24) to qualitatively examine mechanisms impacting readmission risk and patient-centered outcomes post discharge. The researchers will utilize multi-methods to triangulate and contextualize the findings.

Conditions

Hospital Readmissions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Care Transitions Intervention

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

Group Type: EXPERIMENTAL

Care Transitions Intervention

Intervention Type: 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.

Care Transition Intervention and Peer Support

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

Group Type: EXPERIMENTAL

Care Transitions Intervention and Peer Support

Intervention Type: 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).

Usual Care

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

Group Type: OTHER

Usual Care

Intervention Type: 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.

Interventions

Care Transitions Intervention

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.

Intervention Type: BEHAVIORAL

Care Transitions Intervention and Peer Support

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).

Intervention Type: BEHAVIORAL

Usual Care

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.

Intervention Type: OTHER

Other Intervention Names

CTI; CTI + PS; UC

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Tampa General Hospital

OTHER

Sponsor Role: collaborator

Lakeland Regional Health Medical Center

UNKNOWN

Sponsor Role: collaborator

AdventHealth

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amber M Gum, Phd

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

Other Identifiers

AD-2019C1-16066

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY002687

Identifier Type: -

Identifier Source: org_study_id