Alzheimer Disease, Dementia
Conditions
Brief summary
This study is a parallel arm, cluster randomized trial (CRT) to test the efficacy of Connect-Home ADRD, a transitional care intervention focusing on Skilled Nursing Facility (SNF) patients with Alzheimer's disease and dementias and their caregivers during transitions from SNFs to home, assisted, living, and long-term care. The primary hypothesis is that the intervention will reduce caregiver strain (Aim 1) and patient neuropsychiatric symptoms (Aim 2).
Detailed description
Connect-Home ADRD is a Donabedian-guided intervention that introduces new structure and processes to support Skilled Nursing Facility (SNF) staff delivery of transitional care for transitions to home, assisted living, or long-term care, and post-discharge transitional care by the Dementia Caregiving Specialist (DCS). The research objective is to test the efficacy of Connect-Home ADRD, a transitional care intervention, targeting Skilled Nursing Facility (SNF) patients with Alzheimer's disease and related dementias (ADRD) and their primary caregivers who discharge home and other settings of care. The study will be set in 12 North Carolina SNFs and in the patient's discharge destination (during intervention periods only). Using a cluster-randomized trial design, twelve SNFs will be randomly allocated to an intervention group (N=6 SNFs) and to a control group (N=6 SNFs) by a study statistician masked to SNF identity. 360 dyads of SNF patients with ADRD and caregivers will be enrolled in 12 SNFs.
Interventions
BEHAVIORALConnect-Home ADRD
Connect-Home ADRD will introduce new structure and processes to support SNF staff delivery of transitional care for transitions to home, assisted living, or long-term care, and post-discharge transitional care by the Dementia Caregiving Specialist.
Sponsors
University of North Carolina, Chapel Hill
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Before enrollment of SNF patients and caregivers, randomization of the 12 SNFs will be conducted by blinded study staff who will use codes to conceal allocation and randomly assign SNFs in a 1:1 ratio to intervention and control arms. Study staff masked to study arm will assess outcomes, in a telephone-based interview with caregivers in both arms, 30 days after SNF discharge, this is for research purposes only. Research coordinators (RCs) will conduct 30-day electronic health record (EHR) reviews after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients: * Ability to speak English * Goal of discharge to home, assisted living, or long-term care * Diagnosis of dementia * Having a caregiver willing to participate Caregivers: * Ability to speak English * Legally authorized representative (LAR) who also provides support for the person with ADRD Inclusion criteria for SNFs: * Location within 120 miles of UNC-Chapel Hill * Admission of at least 75 SNF patients per year
Exclusion criteria
Patients: * Planned hospital readmission for procedures or treatments within 30 days post enrollment. Caregivers: * LAR is a court-appointed guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Strain | 30 days after discharge from SNF | Modified Caregiver Strain Index Score (MCSI): 13 yes-no items, measure indicators of caregiver strain over the past 30 days. Summary score ranges from 0-26, higher scores indicating greater strain. |
| Patient Neuropsychiatric Symptoms | 30 days after discharge from SNF | Neuropsychiatric Inventory-Q (NPI-Q): 12 items on a 3-point scale, measures presence and severity of neuropsychiatric symptoms over the past 30 days. Summary score ranges from 0-36, higher scores associated with more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Depression | 30 days after discharge from SNF | Patient Health Questionnaire-8 (PHQ-8): 9 items on a 4-point scale, measures depressive symptoms over the past 30 days. Scores range from 0-27, higher scores indicate more depressive symptoms. |
| Preparedness for care transitions | 30 days after discharge from SNF | Care Transitions Measure-15 (CTM-15): 15 items on a 4-point scale, measures self-reported knowledge to continue care after discharge. Summary score ranges from 0-100, higher scores associated with less acute care use after discharge. |
| Patient Quality of Life | 30 days after discharge from SNF | Quality of Life in Alzheimer's Disease (QoL-AD): 13 items on a 4-point scale measuring caregiver-reported quality of life in people with ADRD over the past 30 days. Summary scores range from 13-52, with higher scores indicating higher quality of life. |
| Acute Care Use | 30 days after discharge from SNF | Caregiver-reported days of emergency department and hospital use in 30 days after SNF discharge. |
Countries
United States
Contacts
CONTACTMolly Lynch, MS
CONTACTKathryn Wessell, MPH
PRINCIPAL_INVESTIGATORMark Toles, PhD, RN
University of North Carolina, Chapel Hill
Outcome results
None listed