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Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers

29 de julio de 2026 actualizado por: Wake Forest University Health Sciences
This study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or going back into the hospital. The study team also wants to see if the family-centered approach helps improve the patient's ability to do everyday activities without feeling overwhelmed. Two approaches are being compared: one focuses just on the patient, and the other includes special strategies to better support families involved too. Family will be involved in assessing what the patient and family needs. The family-focused approach not only emphasizes the experience, health, and safety of the patient but also the experience of the family member caring for the older adult. The study also involves families in education and provides families skills-building experiences that can help with caregiving stress, problem-solving, and communicating with the healthcare team. The approach will help the family member prepare for their loved one's transition home and provide coaching with the goal of reducing the mental, physical and financial burden of providing care at home. To spread the intervention across many states, the study team will be using telephone calls, video calls, and other technologies as families prefer.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

For all patients, the transition from hospital to home is a vulnerable period, placing them at great risk for adverse events. In a landmark 2003 report on care transitions, investigators found that 19% of patients experience adverse events soon after discharge (many preventable or ameliorable) and 66% experience adverse drug events. Care transitions also impact those around the recently discharged patient - increasing the burden on family members who provide caregiving support. Without communication and engagement in care transitions, family members experience reduced preparedness for their post-discharge caregiving role, increased caregiver burden, social isolation, and reduced mental/physical well-being.

Patient-centered care transitions can be supported through evidence-based interventions. Recent knowledge generated through PCORI's Transitional Care Evidence to Action Network and other research programs has identified remaining evidence gaps. This Phased Large Award for Comparative Effectiveness Research entitled Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers will create new knowledge related to engaging and supporting family caregivers. After optimization in the feasibility phase, briefly, the Phase 2 comparative effectiveness trial will have the following characteristics:

Setting: 20 Acute Care Hospitals across 5 states selected for rural/urban diversity and patient characteristics Sample: Dyads: Older Adults (N = 1,200) discharged to home and their Family Caregivers (N = 1,200)

Comparators:

Comparator A is an active care transition program that includes effective strategies focused on the patient.

Comparator B includes all Comparator A active strategies, plus focused family caregiver engagement and support.

Randomization:

1:1 Dyad-level RCT stratified by rural/urban home setting and presence of patient cognitive impairment

Patient-Centered Outcomes Include: Patient remaining safely at home (60-day hospital free days), post-discharge adverse events, patient-reported outcomes (e.g.: role functioning). Also, this study extends beyond prior effectiveness research by assessing family-caregiver-reported outcomes (e.g.: caregiver burden).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

2560

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • North Carolina
      • Bermuda Run, North Carolina, Estados Unidos, 27006
      • High Point, North Carolina, Estados Unidos, 27262
      • North Wilkesboro, North Carolina, Estados Unidos, 28659
        • Reclutamiento
        • Atrium Health Wake Forest Baptist Wilkes Medical Center
        • Contacto:
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Reclutamiento
        • Atrium Health Wake Forest Baptist Medical Center
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Patient Inclusion Criteria:

  • 65 and older
  • English and Spanish speaking
  • Preadmission location: community dwelling
  • Distance from Hospital: Local and Distant (rural) included
  • Cognitive impairment, dementia allowed
  • Technology Literacy: Flexible from high to low
  • EPIC readmission risk score over 12
  • Discharged home

Patient Exclusion Criteria:

  • Admitted from skilled nursing facility
  • Discharged to skilled nursing facility
  • Left Against Medical Advice (AMA)
  • Planned readmission
  • Died during index admission
  • Caregiver unwilling to participate

Caregiver Inclusion Criteria:

  • Adults 18 and older
  • English and Spanish speaking
  • Providing tangible support to patient
  • Distance from Hospital: Local and Distant (rural) included
  • Only Mild Cognitive Impairment allowed
  • Able to be trained in Video Visit Technology
  • Available to support post-discharge

Caregiver Exclusion Criteria:

• Has a greater than a mild cognitive impairment (< 12 on MCA)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Patient Focused Strategies
An active care transition program that includes effective strategies focused on the patient.
Otro: Patient-Centered Program
Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
Experimental: Patient and Family Focused Strategies
An active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support.
Otro: Patient-Centered Program
Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
Otro: Family Caregiver Enhanced Program
Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospital-Free Days
Periodo de tiempo: Day 60
The count of days alive and outside acute care hospitals from discharge to day 60. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).
Day 60

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Hospital-Free Days
Periodo de tiempo: Day 30, 90, and 180
The count of days alive and outside acute care hospitals from discharge to a specified day. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).
Day 30, 90, and 180
Number of Patient Readmissions
Periodo de tiempo: Day 30, 60, and 90
All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data.
Day 30, 60, and 90
Zarit Burden Interview Score
Periodo de tiempo: Day 60
Caregiver burden will be measured using the 12-item Zarit Burden Interview. Scores will range from 0 to 48. Higher scores indicate greater burden.
Day 60
Zarit Burden Interview Score
Periodo de tiempo: Day 30, 90, and 180
Caregiver burden will be measured using the 12-item Zarit Burden Interview. Scores will range from 0 to 48. Higher scores indicate greater burden.
Day 30, 90, and 180
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Periodo de tiempo: Day 60
Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family). It will be measured by using the APS-SF8. Each item is scored using a 5-point Likert scale (1=Never, 5=Always). Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.
Day 60
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Periodo de tiempo: Day 30, 90 and 180
Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family). It will be measured by using the APS-SF8. Each item is scored using a 5-point Likert scale (1=Never, 5=Always). Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.
Day 30, 90 and 180
Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score
Periodo de tiempo: Day 7
Patient satisfaction will be measured using the 9-item PACT-M-1. Scores will range from 9 to 45. Higher scores indicate better perception of the quality of discharge arrangements.
Day 7
Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score
Periodo de tiempo: Day 30
Patient self-efficacy will be measured using the 8-item PACT-M-2. Scores will range from 8 to 40. Higher scores indicate a better experience with managing care at home.
Day 30
Patient Activation Measures Score
Periodo de tiempo: Day 60
Patient activation will be measured using the 13-item Patient Activation Measures. Scores will range from 0 to 100. Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.
Day 60
Preparedness for Caregiving Scale Score
Periodo de tiempo: Day 7
Family caregiver preparedness will be measured using the 8-item Preparedness for Caregiving Scale. Scores will range from 0 to 32. Higher scores indicate better preparedness for the caregiving role.
Day 7
Caregiver Self-Efficacy Scale Score
Periodo de tiempo: Day 30
Family caregiver self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale. Scores will range from 8 to 80. Higher scores indicate higher self-efficacy.
Day 30
Caregiver Activation Measures Score
Periodo de tiempo: Day 60
Patient activation will be measured using the 13-item Caregiver Activation Measures. Scores will range from 0 to 100. Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.
Day 60
Visit Completion Rate
Periodo de tiempo: Day 14 and 30
Number of patients that completed follow-up visit
Day 14 and 30
Time to First Outpatient Follow-up
Periodo de tiempo: Day 14 and 30
Number of days between discharge and first outpatient follow-up visit
Day 14 and 30
Rate of Access to Community Services - Patient
Periodo de tiempo: Day 30 and 60
Number of patients that had screening and intervention assessment for unmet social needs.
Day 30 and 60
Rate of Access to Community Services - Caregiver
Periodo de tiempo: Day 30 and 60
Number of caregivers that had screening and intervention assessment for unmet social needs
Day 30 and 60
Partners at Care Transitions Measures - Adverse Events Score
Periodo de tiempo: Day 7 and 30
Adverse events will be measured using the 7-item Partners at Care Transitions Measures. Scores will range from 7 to 30. Higher scores indicate greater care problems and more adverse events post discharge.
Day 7 and 30
Mortality Rate
Periodo de tiempo: Day 60 and 180
Count of days to date of patient death
Day 60 and 180
Montreal Cognitive Assessment 5-minute Protocol Score
Periodo de tiempo: Day 0, 60, and 180
Cognitive function (attention, orientation, language, memory, and executive function) will be measured using the Montreal Cognitive Assessment 5-min protocol. Scores will range from 0 to 30. Higher scores indicate better cognitive function.
Day 0, 60, and 180

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Wake Forest University Health Sciences

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

  • Investigador principal: Thomas Houston, MD, Wake Forest University Health Sciences

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de julio de 2026

Finalización primaria (Estimado)

1 de noviembre de 2031

Finalización del estudio (Estimado)

1 de noviembre de 2031

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de julio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00145199
  • PLACER-2025C1-43844 (Otro número de subvención/financiamiento: Patient Centered Outcomes Research Institute)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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