Two-Phased Study of SPIRIT in Mild Dementia
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| ClinicalTrials.gov Identifier: NCT03311711 |
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Recruitment Status :
Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : October 3, 2022
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The proposed study will adapt and pilot test an efficacious advance care planning interventions, 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.
The study includes two phases: Phase I to adapt, pretest, and refine SPIRIT, and Phase II to pilot test the refined SPIRIT to formally evaluate its feasibility, acceptability, and preliminary efficacy. The final products will be the modified SPIRIT intervention that improves dementia patient and surrogate outcomes, and standardized intervention manuals, including the SPIRIT Interview Guide, fidelity assessment, and training materials.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dementia | Behavioral: SPIRIT-in person Behavioral: SPIRIT-remote Behavioral: Usual care | Not Applicable |
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.
As of July 2020, recruitment of Phase II 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 will be randomized to the SPIRIT-remote or usual care study arms.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 242 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | During Phase I, 20 patient and surrogate dyads (40 participants in total) participated in the first phase of the study which refined the intervention to address the needs of this specific population. The dyads were randomized to the SPIRIT-in person or SPIRIT-remote study arms. Enrollment and data collection for Phase I was completed in October 2018. In the randomized control trial portion of the study (Phase II), 120 dyads (240 participants in total) will be randomized to one of three different study arms: SPIRIT-in person, SPIRIT-remote, or usual care. |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Preparation for End-of-Life Decision Making in Mild Dementia |
| Actual Study Start Date : | May 4, 2018 |
| Actual Primary Completion Date : | February 3, 2022 |
| Estimated Study Completion Date : | January 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SPIRIT-in person
Patients and surrogates who participate in the SPIRIT intervention in person.
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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. |
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Experimental: SPIRIT-remote
Patients and surrogates who participate in the SPIRIT intervention remotely, via teleconference.
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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. |
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Active Comparator: Usual care
Patients and surrogates who receive the standard information about advance directives that is provided at the time of diagnosis.
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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 Name: Clinic standard of care |
- Change in dyad congruence among Phase II participants [ Time Frame: Baseline, follow up phone call (2-3 days post-intervention) ]Dyad congruence will be 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". Patients 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.
- Change in Surrogate's Decision Making Confidence (DMC) scale score among Phase II participants [ Time Frame: Baseline, follow up phone call (2-3 days post-intervention) ]Surrogate decision-making confidence will be 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.
- Change in Surrogate's Overall Preparedness Scale [ Time Frame: Baseline, follow up phone call (2-3 days post-intervention) ]The Overall Preparedness Scale for end-of-life decision making for surrogates is a 21-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 21 to 84, with higher scores indicating higher levels of preparedness.
- Completion of Advance Directives among Phase II participants [ Time Frame: 12 months post-intervention ]Medical records will be 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 is no documentation, the surrogate will be contacted to get confirmation on the status of the Advance Directive.
- Change in Patient's Overall Preparedness Scale [ Time Frame: Baseline, follow up phone call (2-3 days post-intervention) ]The Overall Preparedness Scale for end-of-life decision making for patients is a 20-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 20 to 80, with higher scores indicating higher levels of preparedness.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311711
| United States, Georgia | |
| Assisted Living Facilities in the Metro Atlanta Area | |
| Atlanta, Georgia, United States, 30030 | |
| Grady Health System | |
| Atlanta, Georgia, United States, 30303 | |
| Emory Clinic Geriatrics | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Illinois | |
| Rush Alzheimer's Disease Center | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern University | |
| Evanston, Illinois, United States, 60208 | |
| Principal Investigator: | Mi-Kyung Song, PhD | Emory University |
| Responsible Party: | Mi-Kyung Song, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT03311711 |
| Other Study ID Numbers: |
IRB00099738 1R01AG057714 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 17, 2017 Key Record Dates |
| Last Update Posted: | October 3, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alzheimer's Disease Aging Behavioral Research |
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Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |