Advance Care Planning in Cognitive Disorders Clinic

Advance Care Planning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864965
• Other study ID #: IRB201900108
• Secondary ID: ID00023545OCR210
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 9, 2022

Study information

• Verified date: September 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Advance Care Planning
• Cognition Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Neurology, College of Medicine, UF Health Medical Plaza	Gainesville	Florida
United States	UF Health Fixel Center for Neurological Diseases	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in rate of advance directive completion during or following the visit		Baseline; Month 6; Month 12; Month 18
Primary	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	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
Secondary	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