Outreach-ER: A Dementia Care Intervention Program

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.

Study Overview

• Status: Terminated
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Outreach-ER

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Population includes people living with dementia (PLWD) who are treated at the Regions Hospital Emergency Department in Saint Paul, MN.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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/people living with dementia (PLWD).	Behavioral: Outreach-ER; The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER	Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment.	4 months
Recruitment Rate for Feasibility and Acceptability of Outreach-ER	Percentage of participant/care partner dyads who enroll and consent [range: 0-100%]. Higher number indicates more feasibility.	4 months
Participant Rate for Feasibility and Acceptability of Outreach-ER	Percentage of participant/care partner dyads who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility.	First day of intervention
Completion Rate for Feasibility and Acceptability of Outreach-ER	Percentage of participant/care partner dyads who complete intervention (7 or more visits) [range: 0-100%]. Higher number indicates more feasibility.	about 4 months
Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER	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.	about 4 months
Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER	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.	about 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Bhavani Kashyap, MBBS, PhD, HealthPartners Neuroscience Research; Principal Investigator: Leah R Hanson, PhD, HealthPartners Neuroscience Research

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: A22-086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No