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Clinical Trials/NCT05887388
NCT05887388
Completed
Not Applicable

Adapting Connect-Home Transitional Care to Fit the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers: A Pilot Study

University of North Carolina, Chapel Hill1 site in 1 country38 target enrollmentSeptember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pathologic Processes
Sponsor
University of North Carolina, Chapel Hill
Enrollment
38
Locations
1
Primary Endpoint
Mean Patient Intervention Satisfaction Scores
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This primary purpose of this study will be to (1) examine the feasibility and acceptability of transitional care focusing on care needs of skilled nursing facility (SNF) patients with dementia and their caregivers (primary aim). The secondary purpose will be to describe the effect of the intervention on SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role, caregiver burden and caregiver distress).

Detailed Description

Persons with Alzheimer's disease and related dementia (ADRD) and their caregivers confront complex health challenges during transfers from skilled nursing facilities (SNF) to home, such as recent acute illness and functional losses, incurable medical conditions, patient dependence on family caregivers, and sequelae of declining cognitive ability, such as agitated or aggressive behavior and depression. Other research indicates that usual discharge planning does not address the unique care needs of SNF patients with ADRD and caregiver dyads as they prepare for SNF discharge and begin home-based care. Building on our previous studies and observational studies of unmet care needs of SNF patients with ADRD and their caregivers, the investigators developed Connect-Home Plus, a transitional care intervention to prepare dyads for SNF discharge and caregiver support at home after SNF discharge. Connect-Home Plus will provide new versions of the Connect-Home transitional plan of care EHR template, toolkit, and staff training protocol. The adapted version will support staff in tailoring the transitional care processes to fit the needs of persons with ADRD and their caregivers. It will include (1) new tools to move staff stepwise through a process to prepare persons with AD/ADRD for discharge, and (2) staff training to increase the ability of staff to tailor transitional care plans for the unique needs of persons with ADRD and their caregivers. The investigators will use a single-arm post-test-only trial design with a sample of 20 persons with ADRD and 20 caregivers in 2 SNFs over 6 months. The investigators will determine the feasibility and acceptability of Connect-Home Plus and estimated mean outcomes of persons with ADRD and their caregivers. Feasibility will be assessed with a chart review of SNF medical records. Acceptability will be assessed with questionnaire with patients and caregivers in 21 days after patient discharge from the SNF to home. Patient and caregiver outcomes will be assessed with questionnaires in 30 days after patient discharge from the SNF to home. Data will be analyzed using descriptive statistics.

Registry
clinicaltrials.gov
Start Date
September 10, 2021
End Date
March 18, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • be able to speak English
  • have a goal of discharge to home
  • have a diagnosis of ADRD, or a Brief Inventory of Mental Status (BIMS) score \<13, or (for persons unable to complete the BIMS assessment), have a Cognitive performance score of ≥3 (calculated using data in the Minimum Data Set 3.0 and an algorithm for estimating cognitive impairment using Minimum Data Set 3.0 data other than BIMS)
  • have a caregiver willing to participate.
  • for patients with documentation in the medical record of a caregiver who is the patient's legally authorized representative, consent of the caregiver to participate in the study as the patient's representative.

Exclusion Criteria

  • unable to speak English
  • Caregiver Inclusion Criteria
  • self-reports assisting the patient at home
  • the ability to speak English.
  • Caregiver Exclusion Criteria
  • unable to speak English

Outcomes

Primary Outcomes

Mean Patient Intervention Satisfaction Scores

Time Frame: 21 days after SNF discharge

This interview guide will be used to assess the acceptability of Connect-Home Plus with persons with ADRD. The interview will include questions about (1) factors that made the Connect-Home Plus transitional care services easy or difficult to use, (2) specific supports that were and were not helpful, (3) the effect of Connect-Home Plus on how to manage issues related to ADRD at home, and (4) unmet needs for care of issues related to ADRD at home. Responses to the interview guide questions will be used to generate 3 4-point Likert scale acceptability scores, including (1) how helpful was Connect-Home Plus, (2) how difficult were these services to use, and (3) how well did these services prepare you for care at home. The scores will include 0 meaning not applicable, and scores 1-3 indicating acceptability, with lower scores indicating higher acceptability.

Mean Caregiver Intervention Satisfaction Scores

Time Frame: 21 days after SNF discharge

This interview guide will be used to assess the acceptability of Connect-Home Plus with caregivers of persons with ADRD. This interview guide will include questions about (1) factors that made the Connect-Home Plus transitional care services easy or difficult to use, (2) specific supports that were and were not helpful, (3) the effect of Connect-Home Plus on how to manage issues related to ADRD at home, and (4) unmet needs for care of issues related to ADRD at home. Responses to the interview guide questions will be used to generate 3 4-point Likert scale acceptability scores, including (1) how helpful was Connect-Home Plus, (2) how difficult were these services to use, and (3) how well did these services prepare you for care at home. The scores will include 0 meaning not applicable, and scores 1-3 indicating acceptability, with lower scores indicating higher acceptability

Number of Patients for Whom the Intervention Components Were Feasible

Time Frame: 30 days after SNF discharge

Feasibility will measured using an instrument to audit skilled nursing facility medical records of the patient and the intervention log of services for the Patient and Caregiver dyad. It includes eight dichotomous (yes-no) items that indicate feasibility of the Connect-Home Plus intervention. The feasibility items include: (1) completing the Transition Plan of Care; (2) convening the care plan meeting with caregiver attending; (3) reviewing advance directives in the SNF; (4) scheduling follow-up medical appointments; (5) transmitting records to follow-up clinicians; (6) home care nurse completion of the first home visit within 24 hours after discharge; (7) completion of first caregiver support call within 72 hours of discharge; (8) completion of the second and third caregiver support call within one month of discharge. A "Yes" answer indicates that the intervention component was feasible to provide for the patient and caregiver dyad.

Secondary Outcomes

  • Care Transitions Measure-15 (Patient)(7 Days After SNF Discharge)
  • Preparedness for Caregiving Scale (Caregiver)(7 Days After SNF Discharge)
  • Dementia Quality of Life Measure (Patient)(30 Days After SNF Discharge)
  • Life Space Assessment(30 Days After SNF Discharge)
  • Mean Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge (Patient)(30 Days After SNF Discharge)
  • Zarit Caregiver Burden Scale (Caregiver)(30 Days After SNF Discharge)
  • Distress Thermometer (Caregiver)(30 Days After SNF Discharge)
  • Dementia Quality of Life-Proxy Measure (Caregiver)(30 Days After SNF Discharge)

Study Sites (1)

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