Outreach-ER: A Dementia Care Intervention Program

Terminated

• Conditions: Dementia
• Interventions: Behavioral: Outreach-ER

• Registration Number: NCT05451693
• Lead Sponsor: HealthPartners Institute

Brief Summary

This is a feasibility/pilot, prospective cohort study to determine how to implement and refine Outreach-ER intervention for a larger clinical study. A key feature of Outreach-ER is to reach out to people living with dementia (PLWD) and their families following an emergency room visit or hospitalization. The outcome of this study will help in the overall goal of studying the impact of Outreach-ER in a larger clinical study and focus on outcomes relevant to PLWD and their care partners.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-11
• Study Start: 2022-09-08
• Status Verified: 2022-10
• Primary Completion: 2023-01-27
• Study Completion: 2023-03-30
• Results First Submitted: 2024-04-01
• Results First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Results First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• PLWD with a recent Emergency department visit or admission at Regions Hospital
• Diagnosis of dementia based on international classification of diseases (ICD) Codes in the medical record
• Provides informed consent prior to participation
• Must be able to read and speak English
• PLWD Living at Home
• Age >=18 years for PLWD and their care partner

Exclusion Criteria

• PLWD living in a nursing home/Long term care - Assisted living facility
• Current involvement in another clinical research study/trial for care partners
• PLWD medical record number (MRN) on the HealthPartners (HP) exclusion list

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outreach-ER	Outreach-ER	Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.

Primary Outcome Measures

Name	Time	Method
Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER	4 months	Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment.
Recruitment Rate for Feasibility and Acceptability of Outreach-ER	4 months	Percentage of participant/care partner dyads who enroll and consent \[range: 0-100%\]. Higher number indicates more feasibility.
Participant Rate for Feasibility and Acceptability of Outreach-ER	First day of intervention	Percentage of participant/care partner dyads who start Outreach-ER program \[range: 0-100%\]. Higher number indicates more feasibility.
Completion Rate for Feasibility and Acceptability of Outreach-ER	about 4 months	Percentage of participant/care partner dyads who complete intervention (7 or more visits) \[range: 0-100%\]. Higher number indicates more feasibility.
Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER	about 4 months	Percentage of participant/care partner dyads who complete each intervention visit \[range: 0-100%\].; Number of total intervention visits completed = total completed visits for the 4 dyads.; Number of total intervention visits available = 6 visits x 4 dyads = 24 visits. Number of total intervention visits completed/24 total intervention visits x 100 = percentage.; Higher number indicates more feasibility.
Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER	about 4 months	Percentage of participant/care partner dyads who complete each questionnaire \[range: 0-100%\].; Number of total questionnaires completed = total completed questionnaires for the 4 dyads.; Number of total questionnaires available = 3 questionnaires x 4 dyads x 2 visit time points = 24 available questionnaires.; Number of total questionnaires completed/24 total questionnaires available x 100 = percentage.; Higher number indicates more feasibility.

Secondary Outcome Measures

Name	Time	Method
Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER	about 4 months	Percentage of care partners that respond to all of the items on each scale \[range: 0-100%\]. Higher number indicates more feasibility.

Trial Locations

Locations (2)

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States