Advance Care Planning in Cognitive Disorders Clinic

Responses to a Standardized Approach to Advance Care Planning in Cognitive Disorders Clinic

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.

Study Overview

• Status: Completed
• Conditions: Advance Care Planning
• Intervention / Treatment: Other: Advance Care Planning

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Department of Neurology, College of Medicine, UF Health Medical Plaza
    • Gainesville, Florida, United States, 32611
      • UF Health Fixel Center for Neurological Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI	Other: Advance Care Planning; The provider will guide advance care planning conversations with patients identified with mild or moderate dementia during their third office visit, approximately three months after the first visit.
No Intervention: Control Patients; Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Change in Hospital Anxiety and Depression Scale (HADS)	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).	Baseline; Month 2; Month 3
Change in Beck Hopelessness Scale (BHS)	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).	Baseline; Month 2; Month 3

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Neal Weisbrod, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: IRB201900108; ID00023545 (Other Grant/Funding Number: FL DOH); OCR21061 (Other Identifier: UF OnCore)

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