Clinical trial NCT05887388: Adapting Connect-Home Transitional Care for the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathologic Processes
Keywords: Transitional Care
Skilled Nursing Facilities
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-06-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This feasibility and acceptability study will use a single-arm, post-test-only trial design.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Patient 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.

Patient 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

Primary outcomes:
measure: Number of Patients for Whom the Intervention Components Were Feasible
timeFrame: 30 days after SNF discharge
measure: Mean Patient Intervention Satisfaction Scores
timeFrame: 21 days after SNF discharge
measure: Mean Caregiver Intervention Satisfaction Scores
timeFrame: 21 days after SNF discharge
Secondary outcomes:
measure: Care Transitions Measure-15 (Patient)
timeFrame: 7 Days After SNF Discharge
measure: Preparedness for Caregiving Scale (Caregiver)
timeFrame: 7 Days After SNF Discharge
measure: Life Space Assessment
timeFrame: 30 Days After SNF Discharge
measure: Dementia Quality of Life Measure (Patient)
timeFrame: 30 Days After SNF Discharge
measure: Dementia Quality of Life-Proxy Measure (Caregiver)
timeFrame: 30 Days After SNF Discharge
measure: Mean Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge (Patient)
timeFrame: 30 Days After SNF Discharge
measure: Zarit Caregiver Burden Scale (Caregiver)
timeFrame: 30 Days After SNF Discharge
measure: Distress Thermometer (Caregiver)
timeFrame: 30 Days After SNF Discharge
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mark Toles, MPH
role: PRINCIPAL_INVESTIGATOR
References: