Advance Care Planning in Cognitive Disorders Clinic

NCT03864965 | Completed

• 3 other identifiers: IRB201900108ID00023545OCR21061
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Advance Care Planning

Keywords

Alzheimer's disease; Dementia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Hospital Anxiety and Depression Scale (HADS)

  Baseline; Month 2; Month 3

• Change in Beck Hopelessness Scale (BHS)

  Baseline; Month 2; Month 3

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Patients

NO INTERVENTION

Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI

Interventions

Advance Care Planning OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• Florida Department of Health: collaborator

Study Sites (2)

Department of Neurology, College of Medicine, UF Health Medical Plaza

Gainesville, Florida, 32610, United States

Location

UF Health Fixel Center for Neurological Diseases

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Advance Care Planning

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Neal Weisbrod, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: July 1, 2019
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)