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Examination of The Evidence-Based Care Transitions Intervention Enhanced With Peer Support to Reduce Racial Disparities in Hospital Readmissions and Negative Outcomes Post Hospitalization

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Qué se está evaluando

Care Transitions Intervention

+ Care Transitions Intervention and Peer Support

+ Usual Care

ConductualOtro
Quiénes están siendo reclutados

A partir de 60 años
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Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: mayo de 2022
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of South Florida
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 19 de mayo de 2022

Fecha en la que se inscribió al primer participante.

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.

Título OficialExamination of The Evidence-Based Care Transitions Intervention Enhanced With Peer Support to Reduce Racial Disparities in Hospital Readmissions and Negative Outcomes Post Hospitalization
NCT04981977
Patrocinador PrincipalUniversity of South Florida
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 483 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 60 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

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)

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

3 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

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

Grupo II

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

Grupo III

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

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

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University of South Florida

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