Preparation for End-of-Life Decision Making in Mild Dementia

March 17, 2023 updated by: Mi-Kyung Song, Emory University
The proposed study will adapt and pilot test an efficacious advance care planning interventions, Sharing Patient's Illness Representations to Increase Trust (SPIRIT), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. Patient and surrogate decision maker dyads will participate in a single SPIRIT session and will then have a follow up phone call 2-3 days later. One year after the SPIRIT session some surrogates will be contacted to provide additional feedback about the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Progressive memory loss and impairment of reasoning and judgment are the main symptoms of dementia (including Alzheimer's Disease). For this reason, people in the early stages of dementia are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate.

The most common type of ACP is completing a medical power of attorney or living will, which does not require the patient and/or the family to understand the complexity of the medical decision-making process faced by the surrogate as the patient progresses to advanced disease. The failure to engage in ACP before the window of opportunity closes (i.e., before loss of decision making capacity) has serious adverse consequences with the greatest impact on the surrogate. As a matter of course in dementia, family members are left to make decisions regarding care transition, tube feeding, and other life-sustaining treatment without input from the patient and in the absence of a full understanding of the wishes, values and preferences of the patient.

To make an impact on the state of ACP for patients with dementia and their surrogates, the researchers will adapt and pilot test an efficacious ACP intervention, Sharing Patient's Illness Representations to Increase Trust (SPIRIT), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. SPIRIT is a brief, scalable patient- and family-centered ACP intervention based on the Representational Approach to Patient Education with a goal to promote cognitive and emotional preparation for end-of-life decision making for patients with a serious or life-threatening illness and their surrogates. SPIRIT focuses on having both the patient and the surrogate fully understand end-of-life decision making in anticipation of a loss of decision-making capacity.

A panel of seven experts will provide feedback on adapting SPIRIT to persons with dementia and their surrogates, followed by pilot testing among the target population to refine the intervention. SPIRIT will also be adapted to a video conference format so that patients and surrogates can receive the intervention in their home. In this study, the SPIRIT intervention will be examined with a randomized clinical trial with three groups: SPIRIT-in person, SPIRIT-remote, and usual care. The researchers will recruit 120 dyads of patients with mild dementia and their surrogates, and the groups will be stratified by race (white vs non-white). The primary outcomes are patient and surrogate self-reported preparedness for end-of-life decision making which will be measured at baseline and shortly after the intervention (by phone in the next 2-3 days). Additionally, the researchers will compare the completion rates of advance directives among the three groups and the impact of the three treatment conditions perceived by surrogates at 1-year post intervention.

As of July 2020, recruitment of participants into the SPIRIT-in person study arm ceased in consideration of social distancing guidelines due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Participants enrolled after this date will be randomized to either the SPIRIT-remote or usual care study arms.

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30030
        • Assisted Living Facilities in the Metro Atlanta Area
      • Atlanta, Georgia, United States, 30329
        • Emory Clinic Geriatrics
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Alzheimer's Disease Center
      • Evanston, Illinois, United States, 60208
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Patients with Mild to Moderate Dementia:

  • A diagnosis of mild to moderate dementia based on a Montreal Cognitive Assessment (MoCA) score greater than or equal to 13, or Mini-Mental State Examination (MMSE) score greater than or equal to 18
  • Have access to a computer and internet connectivity in a private setting (either the patient or the surrogate has access to a computer and internet connectivity)
  • Have decision-making capacity to consent to a low-risk study determined by a score greater than or equal to 11 on the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
  • Able to understand and speak English

Exclusion Criteria for Patients with Mild to Moderate dementia:

  • Lack of an available surrogate
  • Uncompensated hearing deficits
  • Speech impairment

Inclusion Criteria for Surrogates:

  • 18 years or older (to serve as a surrogate decision-maker, the individual must be an adult)
  • Be chosen by the patient to serve as a surrogate decision-maker
  • Have access to a computer and internet connectivity in a private setting (either the patient or the surrogate has access to a computer and internet connectivity)
  • Able to understand and speak English

Exclusion Criteria for Surrogates:

  • Inability to complete questionnaires due to physical or cognitive limitations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPIRIT-in person
Patients and surrogates who participate in the SPIRIT intervention in person.
Behavioral: SPIRIT-in person
The SPIRIT-in person intervention adapted for dementia will include one session and will be conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention is expected to last 45-60 minutes.
Experimental: SPIRIT-remote
Patients and surrogates who participate in the SPIRIT intervention remotely, via teleconference.
Behavioral: SPIRIT-remote
The SPIRIT-remote intervention adapted for dementia will include one session and will be conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention is expected to last 45-60 minutes.
Active Comparator: Usual care
Patients and surrogates who receive the standard information about advance directives that is provided at the time of diagnosis.
Behavioral: Usual care
Participants will receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.
Other Names:
  • Clinic standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyad Congruence With Goals-of-Care Tool
Time Frame: Baseline, follow up phone call at 2-3 days post-intervention
Dyad congruence was assessed using the Goals-of-Care Tool which has been modified to include two scenarios relevant to the context of dementia. There are three response options: "The goals of care should focus on delaying my death no matter what, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment", and "I am not sure". Persons with dementia and surrogates complete this tool independently and their responses are then compared to determine dyad congruence (either congruent in both scenarios or incongruent). If both members of the dyad endorse "I am not sure", they are considered incongruent.
Baseline, follow up phone call at 2-3 days post-intervention
Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants
Time Frame: Baseline, follow up phone call at 2-3 days post-intervention
Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. DMC assesses a surrogate's confidence in knowing the patient's wishes, ability to make treatment decisions even in a highly stressful situation, ability to seek information about risks and benefits of medical choices, ability to handle unwanted pressure from others, and ability to communicate with providers about the patient's wishes. Surrogates indicate how confident they are about making medical decisions, if the patient becomes unable to make their own decisions, by their level of agreement with statements along a scale of (0) "not confident at all" to (4) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.
Baseline, follow up phone call at 2-3 days post-intervention
Surrogate's Overall Preparedness Scale
Time Frame: Baseline, follow up phone call at 2-3 days post-intervention
The Overall Preparedness Scale for end-of-life decision making for surrogates is a 23-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 23 to 92, with higher scores indicating higher levels of preparedness.
Baseline, follow up phone call at 2-3 days post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of Advance Directives Among Phase II Participants
Time Frame: Baseline, up to 12 months post-intervention
At the Baseline visit, participants were asked if they had already completed an advance directive. Medical records were reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there was no documentation in the medical record, the surrogate was contacted to get confirmation on the status of the Advance Directive.
Baseline, up to 12 months post-intervention
Patient's Overall Preparedness Scale
Time Frame: Baseline, follow up phone call at 2-3 days post-intervention
The Overall Preparedness Scale for end-of-life decision making for patients is a 22 item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 22 to 88, with higher scores indicating higher levels of preparedness.
Baseline, follow up phone call at 2-3 days post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mi-Kyung Song, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Actual)

February 3, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00099738
  • 1R01AG057714 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on SPIRIT-in person

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe