Preparation for End-of-Life Decision Making in Mild Dementia
2 other identifiers
interventional
242
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedStudy Start
First participant enrolled
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2022
CompletedResults Posted
Study results publicly available
April 11, 2023
CompletedApril 11, 2023
March 1, 2023
3.8 years
October 12, 2017
February 4, 2023
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Dyad Congruence With Goals-of-Care Tool
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
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
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 Outcomes (2)
Completion of Advance Directives Among Phase II Participants
Baseline, up to 12 months post-intervention
Patient's Overall Preparedness Scale
Baseline, follow up phone call at 2-3 days post-intervention
Study Arms (3)
SPIRIT-in person
EXPERIMENTALPatients and surrogates who participate in the SPIRIT intervention in person.
SPIRIT-remote
EXPERIMENTALPatients and surrogates who participate in the SPIRIT intervention remotely, via teleconference.
Usual care
ACTIVE COMPARATORPatients and surrogates who receive the standard information about advance directives that is provided at the time of diagnosis.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Lack of an available surrogate
- Uncompensated hearing deficits
- Speech impairment
- 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
- Inability to complete questionnaires due to physical or cognitive limitations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (5)
Assisted Living Facilities in the Metro Atlanta Area
Atlanta, Georgia, 30030, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory Clinic Geriatrics
Atlanta, Georgia, 30329, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612, United States
Northwestern University
Evanston, Illinois, 60208, United States
Related Publications (2)
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.
PMID: 31373868BACKGROUNDSong 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.
PMID: 29870867DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mi-Kyung Song, PhD
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Mi-Kyung Song, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 17, 2017
Study Start
May 4, 2018
Primary Completion
February 3, 2022
Study Completion
December 7, 2022
Last Updated
April 11, 2023
Results First Posted
April 11, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share