Clinical trial NCT03311711: Preparation for End-of-Life Decision Making in Mild Dementia
Official title: Preparation for End-of-Life Decision Making in Mild Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Alzheimer's Disease
Aging
Behavioral Research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-10-17
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dyad Congruence With Goals-of-Care Tool
timeFrame: Baseline, follow up phone call at 2-3 days post-intervention
measure: Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants
timeFrame: Baseline, follow up phone call at 2-3 days post-intervention
measure: Surrogate's Overall Preparedness Scale
timeFrame: Baseline, follow up phone call at 2-3 days post-intervention
Secondary outcomes:
measure: Completion of Advance Directives Among Phase II Participants
timeFrame: Baseline, up to 12 months post-intervention
measure: Patient's Overall Preparedness Scale
timeFrame: Baseline, follow up phone call at 2-3 days post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Assisted Living Facilities in the Metro Atlanta Area
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic Geriatrics
state: Georgia
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Emory University
name: Mi-Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song MK, Ward SE, Hepburn K, Paul S, Kim H, Shah RC, Morhardt DJ, Medders L, Lah JJ, Clevenger CC. Can Persons with Dementia Meaningfully Participate in Advance Care Planning Discussions? A Mixed-Methods Study of SPIRIT. J Palliat Med. 2019 Nov;22(11):1410-1416. doi: 10.1089/jpm.2019.0088. Epub 2019 Aug 2.
citation: Song MK, Ward SE, Hepburn K, Paul S, Shah RC, Morhardt DJ. SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial. Contemp Clin Trials. 2018 Aug;71:55-62. doi: 10.1016/j.cct.2018.06.005. Epub 2018 Jun 2.