Dementia
Conditions
Keywords
Alzheimer's Disease, Aging, Behavioral Research
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.
Interventions
BEHAVIORALSPIRIT-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.
BEHAVIORALSPIRIT-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.
BEHAVIORALUsual 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.
Sponsors
National Institute on Aging (NIA)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyad Congruence With Goals-of-Care Tool | Baseline, follow up phone call at 2-3 days post-intervention | 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. |
| Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Baseline, follow up phone call at 2-3 days post-intervention | 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. |
| Surrogate's Overall Preparedness Scale | Baseline, follow up phone call at 2-3 days post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Advance Directives Among Phase II Participants | Baseline, up to 12 months post-intervention | At the Baseline visit, participants were asked if they had already completed an advance directive. Medical records were 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 was no documentation in the medical record, the surrogate was contacted to get confirmation on the status of the Advance Directive. |
| Patient's Overall Preparedness Scale | Baseline, follow up phone call at 2-3 days post-intervention | The Overall Preparedness Scale for end-of-life decision making for patients is a 22 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 22 to 88, with higher scores indicating higher levels of preparedness. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from healthcare clinics in Georgia and Illinois, USA. Participant enrollment began May 4, 2018. Follow-up for the 2-3 day post-intervention assessment was completed by February 3, 2022 and follow up for the 12 months post-intervention time point was completed by December 7, 2022.
Pre-assignment details
In July 2020 the protocol was modified, eliminating the SPIRIT-in person intervention due to the coronavirus disease 2019 (COVID-19) pandemic which prohibited in person research visits. The study design changed to SPIRIT-remote versus usual care and a new randomization method was initiated for the two arm design. Due to the change in randomization method mid-study, participants enrolled before and after the randomization change are analyzed separately (as original or modified randomization).
Participants by arm
| Arm | Count |
|---|---|
| SPIRIT-in Person - Persons With Dementia, Original Randomization Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design. | 15 |
| SPIRIT-in Person - Surrogates, Original Randomization Surrogates participating in the SPIRIT intervention in person, during the original randomization design. | 15 |
| SPIRIT-remote - Persons With Dementia, Original Randomization Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. | 12 |
| SPIRIT-remote - Surrogates, Original Randomization Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. | 12 |
| Usual Care - Persons With Dementia, Original Randomization Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. | 15 |
| Usual Care - Surrogates, Original Randomization Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. | 15 |
| SPIRIT-remote - Persons With Dementia, Modified Randomization Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. | 40 |
| SPIRIT-remote - Surrogates, Modified Randomization Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. | 40 |
| Usual Care - Persons With Dementia, Modified Randomization Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. | 39 |
| Usual Care - Surrogates, Modified Randomization Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. | 39 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Death of dyad partner | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | SPIRIT-in Person - Persons With Dementia, Original Randomization | SPIRIT-in Person - Surrogates, Original Randomization | SPIRIT-remote - Persons With Dementia, Original Randomization | SPIRIT-remote - Surrogates, Original Randomization | Usual Care - Persons With Dementia, Original Randomization | Usual Care - Surrogates, Original Randomization | SPIRIT-remote - Persons With Dementia, Modified Randomization | SPIRIT-remote - Surrogates, Modified Randomization | Usual Care - Persons With Dementia, Modified Randomization | Usual Care - Surrogates, Modified Randomization | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 75.53 years STANDARD_DEVIATION 10.66 | 65.20 years STANDARD_DEVIATION 15.36 | 78.83 years STANDARD_DEVIATION 8.25 | 67.58 years STANDARD_DEVIATION 7.83 | 74.00 years STANDARD_DEVIATION 9 | 62.20 years STANDARD_DEVIATION 12.04 | 74.07 years STANDARD_DEVIATION 8.5 | 65.60 years STANDARD_DEVIATION 12.89 | 72.82 years STANDARD_DEVIATION 8.09 | 68.85 years STANDARD_DEVIATION 9.62 | 70.34 years STANDARD_DEVIATION 11.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 12 Participants | 12 Participants | 15 Participants | 15 Participants | 39 Participants | 39 Participants | 37 Participants | 37 Participants | 236 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 3 Participants | 8 Participants | 7 Participants | 5 Participants | 6 Participants | 52 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 10 Participants | 7 Participants | 7 Participants | 11 Participants | 12 Participants | 32 Participants | 32 Participants | 32 Participants | 32 Participants | 185 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 12 participants | 12 participants | 15 participants | 15 participants | 40 participants | 40 participants | 39 participants | 39 participants | 242 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 5 Participants | 11 Participants | 8 Participants | 9 Participants | 26 Participants | 27 Participants | 18 Participants | 24 Participants | 146 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 7 Participants | 1 Participants | 7 Participants | 6 Participants | 14 Participants | 13 Participants | 21 Participants | 15 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 0 / 15 | 0 / 12 | 0 / 12 | 0 / 15 | 0 / 15 | 1 / 40 | 0 / 40 | 1 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 12 | 0 / 12 | 0 / 15 | 0 / 15 | 0 / 40 | 0 / 40 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 12 | 0 / 12 | 0 / 15 | 0 / 15 | 0 / 40 | 0 / 40 | 0 / 39 | 0 / 39 |
Outcome results
Primary
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.
Time frame: Baseline, follow up phone call at 2-3 days post-intervention
Population: The number of participants analyzed reflects the number of person with dementia and surrogate dyads (two persons per dyad). This analysis includes dyads who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPIRIT-in Person, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at 2-3 Days Post-intervention | 1 Participants |
| SPIRIT-in Person, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at Baseline | 6 Participants |
| SPIRIT-in Person, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at 2-3 Days Post-intervention | 11 Participants |
| SPIRIT-in Person, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at Baseline | 9 Participants |
| SPIRIT-remote, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at Baseline | 4 Participants |
| SPIRIT-remote, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at Baseline | 8 Participants |
| SPIRIT-remote, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at 2-3 Days Post-intervention | 9 Participants |
| SPIRIT-remote, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at 2-3 Days Post-intervention | 3 Participants |
| Usual Care, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at 2-3 Days Post-intervention | 11 Participants |
| Usual Care, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at 2-3 Days Post-intervention | 4 Participants |
| Usual Care, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at Baseline | 11 Participants |
| Usual Care, Original Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at Baseline | 4 Participants |
| SPIRIT-remote, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at Baseline | 24 Participants |
| SPIRIT-remote, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at Baseline | 16 Participants |
| SPIRIT-remote, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at 2-3 Days Post-intervention | 3 Participants |
| SPIRIT-remote, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at 2-3 Days Post-intervention | 34 Participants |
| Usual Care, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at Baseline | 9 Participants |
| Usual Care, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Incongruent Dyads at 2-3 Days Post-intervention | 7 Participants |
| Usual Care, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at Baseline | 30 Participants |
| Usual Care, Modified Randomization | Dyad Congruence With Goals-of-Care Tool | Number of Congruent Dyads at 2-3 Days Post-intervention | 32 Participants |
Primary
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.
Time frame: Baseline, follow up phone call at 2-3 days post-intervention
Population: This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-in Person, Original Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | 2-3 Days Post-intervention | 19.08 score on a scale | Standard Deviation 1.24 |
| SPIRIT-in Person, Original Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Baseline | 18.40 score on a scale | Standard Deviation 1.24 |
| SPIRIT-remote, Original Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Baseline | 18.08 score on a scale | Standard Deviation 1.73 |
| SPIRIT-remote, Original Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | 2-3 Days Post-intervention | 18.42 score on a scale | Standard Deviation 1.83 |
| Usual Care, Original Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Baseline | 18.20 score on a scale | Standard Deviation 1.78 |
| Usual Care, Original Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | 2-3 Days Post-intervention | 19.07 score on a scale | Standard Deviation 1.39 |
| SPIRIT-remote, Modified Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | 2-3 Days Post-intervention | 19.35 score on a scale | Standard Deviation 1.14 |
| SPIRIT-remote, Modified Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Baseline | 18.33 score on a scale | Standard Deviation 2.21 |
| Usual Care, Modified Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | Baseline | 18.10 score on a scale | Standard Deviation 2.1 |
| Usual Care, Modified Randomization | Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants | 2-3 Days Post-intervention | 19.05 score on a scale | Standard Deviation 1.23 |
Primary
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.
Time frame: Baseline, follow up phone call at 2-3 days post-intervention
Population: This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-in Person, Original Randomization | Surrogate's Overall Preparedness Scale | Baseline | 75.27 score on a scale | Standard Deviation 6.91 |
| SPIRIT-in Person, Original Randomization | Surrogate's Overall Preparedness Scale | 2-3 Days Post-intervention | 83.75 score on a scale | Standard Deviation 4.05 |
| SPIRIT-remote, Original Randomization | Surrogate's Overall Preparedness Scale | Baseline | 75.75 score on a scale | Standard Deviation 9.76 |
| SPIRIT-remote, Original Randomization | Surrogate's Overall Preparedness Scale | 2-3 Days Post-intervention | 76.92 score on a scale | Standard Deviation 8.18 |
| Usual Care, Original Randomization | Surrogate's Overall Preparedness Scale | Baseline | 75.53 score on a scale | Standard Deviation 9.15 |
| Usual Care, Original Randomization | Surrogate's Overall Preparedness Scale | 2-3 Days Post-intervention | 78.73 score on a scale | Standard Deviation 8.42 |
| SPIRIT-remote, Modified Randomization | Surrogate's Overall Preparedness Scale | 2-3 Days Post-intervention | 81.50 score on a scale | Standard Deviation 6.97 |
| SPIRIT-remote, Modified Randomization | Surrogate's Overall Preparedness Scale | Baseline | 72.15 score on a scale | Standard Deviation 8.82 |
| Usual Care, Modified Randomization | Surrogate's Overall Preparedness Scale | Baseline | 74.69 score on a scale | Standard Deviation 7.42 |
| Usual Care, Modified Randomization | Surrogate's Overall Preparedness Scale | 2-3 Days Post-intervention | 77.80 score on a scale | Standard Deviation 8.32 |
Secondary
Completion of Advance Directives Among Phase II Participants
At the Baseline visit, participants were asked if they had already completed an advance directive. Medical records were 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 was no documentation in the medical record, the surrogate was contacted to get confirmation on the status of the Advance Directive.
Time frame: Baseline, up to 12 months post-intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPIRIT-in Person, Original Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Complete | 10 Participants |
| SPIRIT-in Person, Original Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Incomplete | 5 Participants |
| SPIRIT-in Person, Original Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Complete | 12 Participants |
| SPIRIT-in Person, Original Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Incomplete | 3 Participants |
| SPIRIT-remote, Original Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Complete | 9 Participants |
| SPIRIT-remote, Original Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Incomplete | 0 Participants |
| SPIRIT-remote, Original Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Incomplete | 3 Participants |
| SPIRIT-remote, Original Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Complete | 12 Participants |
| Usual Care, Original Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Incomplete | 0 Participants |
| Usual Care, Original Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Incomplete | 1 Participants |
| Usual Care, Original Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Complete | 15 Participants |
| Usual Care, Original Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Complete | 14 Participants |
| SPIRIT-remote, Modified Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Complete | 33 Participants |
| SPIRIT-remote, Modified Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Incomplete | 7 Participants |
| SPIRIT-remote, Modified Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Incomplete | 2 Participants |
| SPIRIT-remote, Modified Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Complete | 38 Participants |
| Usual Care, Modified Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Incomplete | 1 Participants |
| Usual Care, Modified Randomization | Completion of Advance Directives Among Phase II Participants | 12-month cumulative - Complete | 38 Participants |
| Usual Care, Modified Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Incomplete | 9 Participants |
| Usual Care, Modified Randomization | Completion of Advance Directives Among Phase II Participants | Baseline - Complete | 30 Participants |
Secondary
Patient's Overall Preparedness Scale
The Overall Preparedness Scale for end-of-life decision making for patients is a 22 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 22 to 88, with higher scores indicating higher levels of preparedness.
Time frame: Baseline, follow up phone call at 2-3 days post-intervention
Population: This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-in Person, Original Randomization | Patient's Overall Preparedness Scale | Baseline | 55.40 score on a scale | Standard Deviation 6.97 |
| SPIRIT-in Person, Original Randomization | Patient's Overall Preparedness Scale | 2-3 Days Post-intervention | 57.83 score on a scale | Standard Deviation 6.6 |
| SPIRIT-remote, Original Randomization | Patient's Overall Preparedness Scale | Baseline | 54.67 score on a scale | Standard Deviation 5.14 |
| SPIRIT-remote, Original Randomization | Patient's Overall Preparedness Scale | 2-3 Days Post-intervention | 58.57 score on a scale | Standard Deviation 5.31 |
| Usual Care, Original Randomization | Patient's Overall Preparedness Scale | Baseline | 54.07 score on a scale | Standard Deviation 7.54 |
| Usual Care, Original Randomization | Patient's Overall Preparedness Scale | 2-3 Days Post-intervention | 54.93 score on a scale | Standard Deviation 9.03 |
| SPIRIT-remote, Modified Randomization | Patient's Overall Preparedness Scale | 2-3 Days Post-intervention | 58.78 score on a scale | Standard Deviation 5.2 |
| SPIRIT-remote, Modified Randomization | Patient's Overall Preparedness Scale | Baseline | 54.90 score on a scale | Standard Deviation 5.71 |
| Usual Care, Modified Randomization | Patient's Overall Preparedness Scale | Baseline | 53.50 score on a scale | Standard Deviation 5.96 |
| Usual Care, Modified Randomization | Patient's Overall Preparedness Scale | 2-3 Days Post-intervention | 54.69 score on a scale | Standard Deviation 5.5 |