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

NCT ID: NCT03311711

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-04
• Study Completion Date: 2022-12-07

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SPIRIT-in person

Patients and surrogates who participate in the SPIRIT intervention in person.

Group Type: EXPERIMENTAL

SPIRIT-in person

Intervention Type: BEHAVIORAL

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.

SPIRIT-remote

Patients and surrogates who participate in the SPIRIT intervention remotely, via teleconference.

Group Type: EXPERIMENTAL

SPIRIT-remote

Intervention Type: BEHAVIORAL

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.

Usual care

Patients and surrogates who receive the standard information about advance directives that is provided at the time of diagnosis.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Clinic standard of care

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

• Inability to complete questionnaires due to physical or cognitive limitations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Mi-Kyung Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi-Kyung Song, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Assisted Living Facilities in the Metro Atlanta Area

Atlanta, Georgia, United States

Grady Health System

Atlanta, Georgia, United States

Emory Clinic Geriatrics

Atlanta, Georgia, United States

Rush Alzheimer's Disease Center

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31373868 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29870867 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AG057714

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00099738

Identifier Type: -

Identifier Source: org_study_id