Clinical trial NCT04981977: Enhancing the Care Transitions Intervention With Peer Support to Reduce Disparities
Official title: Examination of The Evidence-Based Care Transitions Intervention Enhanced With Peer Support to Reduce Racial Disparities in Hospital Readmissions and Negative Outcomes Post Hospitalization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hospital Readmissions
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Tampa General Hospital
name: Lakeland Regional Health Medical Center
name: AdventHealth
First posted: 2021-07-29
Enrollment: 483
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Unplanned All-Cause Hospital Readmissions
timeFrame: 30 days
measure: Unplanned All-Cause Hospital Readmissions
timeFrame: Three months
measure: Unplanned All-Cause Hospital Readmissions
timeFrame: Six months
measure: Related Secondary Health-System Visits (i.e., ED Visits)
timeFrame: 30 days
measure: Related Secondary Health-System Visits (i.e., ED Visits)
timeFrame: Three months
measure: Related Secondary Health-System Visits (i.e., ED Visits)
timeFrame: Six months
Secondary outcomes:
measure: Demographic Questionnaire
timeFrame: At time of enrollment/Baseline
measure: Care Transitions Measure (CTM-3)
timeFrame: 30 days
measure: Care Transitions Measure (CTM-3)
timeFrame: Three months
measure: Care Transitions Measure (CTM-3)
timeFrame: Six months
measure: Self-Efficacy (SES-6)
timeFrame: Baseline
measure: Self-Efficacy (SES-6)
timeFrame: 30
measure: Self-Efficacy (SES-6)
timeFrame: Three months
measure: Self-Efficacy (SES-6)
timeFrame: Six months
measure: Medical Outcomes Study Short Form (MOS SF-36)
timeFrame: Baseline
measure: Medical Outcomes Study Short Form (MOS SF-36)
timeFrame: 30 days
measure: Medical Outcomes Study Short Form (MOS SF-36)
timeFrame: Three months
measure: Medical Outcomes Study Short Form (MOS SF-36)
timeFrame: Six months
measure: Quality of Life (WHOQOL-BRIEF)
timeFrame: Baseline
measure: Quality of Life (WHOQOL-BRIEF)
timeFrame: 30 days
measure: Quality of Life (WHOQOL-BRIEF)
timeFrame: Three months
measure: Quality of Life (WHOQOL-BRIEF)
timeFrame: Six months
measure: Medication Management (MedMaleDE)
timeFrame: Baseline
measure: Medication Management (MedMaleDE)
timeFrame: 30 days
measure: Medication Management (MedMaleDE)
timeFrame: Three months
measure: Medication Management (MedMaleDE)
timeFrame: Six months
measure: Satisfaction Survey
timeFrame: Six months
measure: Caregiver Qualitative Interview
timeFrame: Six months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Amber M Gum, Phd
role: PRINCIPAL_INVESTIGATOR
References: