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OpenTrials
Completed

NCT Number: NCT03864965

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.

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Key information

Conditions

Advance Care Planning Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Change in rate of advance directive completion during or following the visit

    Time frame: Baseline; Month 6; Month 12; Month 18

  2. Change in the rate of completed advance directives that are uploaded to the patient's electronic medical record

    Time frame: Baseline; Month 6; Month 12; Month 18

Secondary outcomes

  1. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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).

  2. Change in Beck Hopelessness Scale (BHS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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