Advance Care Planning in Cognitive Disorders Clinic

Not Applicable

Completed

• Conditions: Advance Care Planning
• Interventions: Other: Advance Care Planning

• Registration Number: NCT03864965
• Lead Sponsor: University of Florida

Brief Summary

Advance care planning among patients with cognitive disorders poses unique challenges to clinicians. To improve planning in patients with Alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. The main outcome measure is the rate of entry of Advance Directive completion in the patient's Electronic Health Record (EHR). A control group of similar patients from another provider specializing in cognitive disorders will be used to tease out confounding variable effects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Study Start: 2019-07-01
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients having mild cognitive impairment (MCI) or very mild to mild dementia (CDR 0.5-1).

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Exclusion Criteria

• Patients with moderate to severe dementia (CDR 2-3).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Advance Care Planning	Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI

Primary Outcome Measures

Name	Time	Method
Change in rate of advance directive completion during or following the visit	Baseline; Month 6; Month 12; Month 18
Change in the rate of completed advance directives that are uploaded to the patient's electronic medical record	Baseline; Month 6; Month 12; Month 18

Secondary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale (HADS)	Baseline; Month 2; Month 3	Scale consisting of 14 items (7 relating to anxiety; 7 to depression). Scores range from 0-21 (0-7 being normal; 08-10 being borderline abnormal; 11-21 being abnormal for anxiety and depression).
Change in Beck Hopelessness Scale (BHS)	Baseline; Month 2; Month 3	Scale consisting of 20 true-false items arrayed within three factors: Feelings about the future, loss of motivation, and future expectations. Scores range from 0-20 (0-3 as are considered within the normal range, 4-8 identify mild hopelessness, scores from 9-14 identify moderate hopelessness, and scores greater than 14 identify severe hopelessness).

Trial Locations

Locations (2)

UF Health Fixel Center for Neurological Diseases; 🇺🇸 Gainesville, Florida, United States

Department of Neurology, College of Medicine, UF Health Medical Plaza; 🇺🇸 Gainesville, Florida, United States