Two-Phased Study of SPIRIT in Mild Dementia

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, SPIRIT (Sharing
Patient's Illness Representations to Increase Trust), 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.

During Phase I of the study, a panel of seven experts will provide feedback on adapting
SPIRIT to persons with dementia and their surrogates. SPIRIT will also be adapted to a video
conference format so that patients and surrogates can receive the intervention in their home.
To pretest the adapted SPIRIT intervention, the first 10 patient and surrogate dyads will be
randomly assigned to SPIRIT-in person or to SPIRIT-remote. After completion of each session
the interventionist will make field notes to document what did or did not go well, reasons
for interruptions or difficulties, and contextual factors that cannot be captured in the
audio-recording. During the post-intervention assessment each participant will complete the
preparedness outcome questionnaires and will be asked about the overall experience with
SPIRIT, any facets of the intervention that the participant found helpful or not helpful and
the reasons (pacing, length, and modality), and suggestions for improvement. The researchers
will alter or refine the intervention before pretesting a second set of 10 dyads.

Phase II of the study is 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. 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.

Inclusion Criteria for Patients with Mild Dementia:

- A diagnosis of dementia

- A Clinical Dementia Rating (CDR) score ≤ 1 (mild dementia), or a recent 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 dementia:

- Lack of an available surrogate

- Uncompensated hearing deficits

- Speech impairment

- Already has an advance directive (Phase II only; determined by the patient's medical
record and confirmed by the surrogate)

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.