Outreach-ER: A Dementia Care Intervention Program

Study Overview
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Brief Summary
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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.

Official Title
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Outreach-ER: A Dementia Care Intervention Program

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Outreach-ER


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outreach-ER<br>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. | Behavioral: Outreach-ER<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempted recruits for feasibility and acceptability of Outreach-ER | Number of potential participants contacted. Higher number indicates higher number of attempts as recruitment. | through study completion, an average of 1.5 years | 
| Recruitment rate for feasibility and acceptability of Outreach-ER | Percentage of participants who enroll and consent [range: 0-100%]. Higher number indicates more feasibility. | through study completion, an average of 1.5 years | 
| Participant rate for feasibility and acceptability of Outreach-ER | Percentage of participants who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility. | through study completion, an average of 1.5 years | 
| Completion rate for feasibility and acceptability of Outreach-ER | Percentage of participants who complete intervention (7 or more visits) [range: 0-100%]. Higher number indicates more feasibility. | through study completion, an average of 1.5 years | 
| Session specific completion rate for feasibility and acceptability of Outreach-ER | Percentage of participants who complete each intervention visit [range: 0-100%]. Higher number indicates more feasibility. | through study completion, an average of 1.5 years | 
| Questionnaire specific response rate for feasibility and acceptability of Outreach-ER | Percentage of participants who complete each questionnaire [range: 0-100%]. Higher number indicates more feasibility. | through study completion, an average of 1.5 years | 

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. | through study completion, an average of 1.5 years |