Adapting Connect-Home Transitional Care for the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers

NCT05887388 | Completed Results DMC

• 2 other identifiers: 20-2406R01NR017636-03
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Pathologic Processes

Keywords

Transitional Care; Skilled Nursing Facilities

Outcome Measures

Primary Outcomes (3)

• Number of Patients for Whom the Intervention Components Were Feasible

  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.

  30 days after SNF discharge

• Mean Patient Intervention Satisfaction Scores

  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.

  21 days after SNF discharge

• Mean Caregiver Intervention Satisfaction Scores

  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

  21 days after SNF discharge

Secondary Outcomes (8)

• Care Transitions Measure-15 (Patient)

  7 Days After SNF Discharge

• Preparedness for Caregiving Scale (Caregiver)

  7 Days After SNF Discharge

• Life Space Assessment

  30 Days After SNF Discharge

• Dementia Quality of Life Measure (Patient)

  30 Days After SNF Discharge

• Dementia Quality of Life-Proxy Measure (Caregiver)

  30 Days After SNF Discharge

Study Arms (1)

Intervention

EXPERIMENTAL

Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.

Behavioral: Connect-Home Plus

Interventions

Connect-Home Plus BEHAVIORAL

Connect-Home Plus will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Plus Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home Plus care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses,therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the illness and functional needs. In Step 2, a dementia caregiving specialist will call the patient's home three times within 30 days of discharge. Both intervention steps will focus on key care needs, such as 1) home safety; 2) care of symptoms of ADRD; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• unable to speak English
• self-reports assisting the patient at home
• the ability to speak English.
• unable to speak English

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mark Toles, PhD
• Organization: University of North Carolina at Chapel Hill

mtoles@email.unc.edu

919-966-5684

Study Officials

• Mark Toles, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This feasibility and acceptability study will use a single-arm, post-test-only trial design.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: September 10, 2021
• Primary Completion: February 27, 2022
• Study Completion: March 18, 2022
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 and continuing for 36 months following publication.
• Access Criteria: Investigators who propose to use the data must have approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)