Outreach-ER: A Dementia Care Intervention Program

February 3, 2025 updated by: HealthPartners Institute
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: First day of intervention
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
Time Frame: about 4 months
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
Time Frame: 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.
about 4 months
Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER
Time Frame: 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.
about 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER
Time Frame: 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.
about 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe