Alzheimer Disease, Dementia, Memory Impairment
Conditions
Keywords
Advance Care Planning, Shared Decision-Making, Web-Based Platform, Memory Care, Nursing Homes
Brief summary
This Our Care Wishes- Dementia pilot study is adapting an existing successful online advance care planning platform to the specific needs of persons living with dementia and shared decision-makers (SDMs) and testing the usability and acceptability among nursing home residents and SDMs.
Interventions
OTHEROur Memory Care Wishes
Our Memory Care Wishes is a web-based advance care planning platform designed for persons living with dementia in nursing homes to discuss and document healthcare and daily life preferences with the help of shared decision-makers. Penn researchers meet via Zoom with PLWD and their SDMS and nursing home staff to facilitate website completion.
Sponsors
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eligible PLWD will be receiving short-or long-term care at a participating NH, have documented moderate to severe cognitive impairment as measured by the Cognitive Function Scale included in the Minimum Data Set 3.0, 65 and have an identified SDM.
Exclusion criteria
* Participants are not eligible discharged from participating NHs, or do not have access to a telephone or video chat.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adapted Decision Making Confidence Scale | Baseline | Items from the Surrogate Decision-Making Confidence Scale and 9-item ACP Engagement Survey were used and adapted to capture the confidence in advanced care planning decision-making from both persons living with dementia and their shared decision-maker' points of view. The scale utilizes a Likert scale with values ranging from 1 (not confident at all) to 5 (very confident). |
| Post Adapted Decision Making Confidence Scale | 1 week | Items from the Surrogate Decision-Making Confidence Scale and 9-item ACP Engagement Survey were used and adapted to capture the confidence in advanced care planning decision-making from both persons living with dementia and their shared decision-maker' points of view. The scale utilizes a Likert scale with values ranging from 1 (not confident at all) to 5 (very confident). This is the second time point the measure was collected. |
| Website Ease of Use | 1 week | This scale measures the ease of use of the website. This scale uses a Likert scale from 0 (very hard) to 10 (very easy). These data were collected from PLWDs and SDMs in the intervention group. |
| Rate of ACP Website Completion - Time | 1 week | This tool measured total time spent by participants on the advance care planning website. Total time in minutes spent on the website were collected. Because SDMs navigated the website with the PLWD alongside them, this measure was only used to SDMs in the intervention group. |
| Rate of ACP Website Completion - Questions Completed | 1 week | This tool measured what percentage of the website was completed by participants. Because SDMs navigated the website with the PLWD alongside them, this measure was only associated with SDMs in the intervention group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Impact Questionnaire | 1 week | Participants were asked if their healthcare preferences changed due to the COVID-19 pandemic. Items included: 1. Since COVID, planning for the future is: (1) less important (2) more important, or (3) the same 2. Since COVID, the sense of urgency to name a supportive decision maker has: (1) increased (2) decreased, or (3) remained the same. 3. Since COVID, my preferences for decisions about breathing machines (ventilators) have: (1) changed or (2) remained the same. 4. Since COVID, my preferences for going to the hospital for care versus receiving treatment in place have:(1) changed, or (2) remained the same. |
Countries
United States
Participant flow
Recruitment details
Dyads (i.e., persons living with dementia (PLWD) and their shared decision-makers (SDMS) were initially recruited by nursing home staff. Then, study staff read an assent script to and reviewed study procedures with interested SDMs. SDMs who agreed to participate were sent a copy of the study summary and assent script. After verbal assent was acquired, dyads (PLWDs and SDMs) were assigned to the intervention group or control arm.
Pre-assignment details
Enrolled participants are organized into 4 individual groups: PLWDs & SDMs in the intervention and control arms. Dyads in all study arms who stopped answering study team calls after initial verbal telephone consent and did not complete the baseline interview were not considered enrolled and are excluded from the Baseline & Follow Up Surveys period below. Demographics were collected during the baseline interview. Nursing home staff were not enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| PLWD: Control Participants living with dementia randomized to the control group will receive usual advanced care planning help from nursing facility staff and will not complete the Our Memory Care Wishes website.
Participants will complete surveys that capture confidence in decision-making at baseline and 1 week. Participants will complete these surveys alongside their shared decision makers. | 3 |
| SDMs: Control Shared decision-makers of persons living with dementia randomized to the control group will work with their care receiver to have usual advanced care planning discussions with nursing facility staff. SDMs in the control group will not complete the Our Memory Care Wishes website.
SDMs will complete surveys that capture confidence in decision-making at baseline and 1 week. SDMs will complete these surveys alongside the nursing home resident they care for. | 3 |
| PLWD: Intervention Persons living with dementia (PLWD) randomized to the intervention group will complete a baseline interview alongside their shared decision-maker (SDM) that collects demographics and their confidence in decision-making.
Then PLWDs will work with their SDM to complete the Our Memory Care Wishes website with the PLWD. Our Memory Care Wishes is a web-based advance care planning platform designed for persons living with dementia in nursing homes to discuss and document healthcare and daily life preferences with the help of shared decision-makers.
1 week after completing the website, PLWDs will complete a follow up interview collecting their confidence in decision-making, ratings of the website and how COVID has affected their decision-making. | 4 |
| SDMs: Intervention Shared decision-makers (SDMs) of persons living with dementia (PLWD) randomized to the intervention group will complete a baseline interview that collects demographics and their confidence in decision-making when it comes to being a surrogate for the PLWD.
Then, SDMs will complete the Our Memory Care Wishes website with the PLWD. Our Memory Care Wishes is a web-based advance care planning platform designed for persons living with dementia in nursing homes to discuss and document healthcare and daily life preferences with the help of shared decision-makers.
1 week after completing the website, SDMs will complete a follow up interview collecting their confidence in decision-making, ratings of the website and how COVID has affected their decision-making. | 4 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | PLWD: Control | SDMs: Control | PLWD: Intervention | SDMs: Intervention | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 78.6 years | 64 years | 89.3 years | 65.5 years | 74.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 10 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 4 participants | 4 participants | 14 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
Primary
Adapted Decision Making Confidence Scale
Items from the Surrogate Decision-Making Confidence Scale and 9-item ACP Engagement Survey were used and adapted to capture the confidence in advanced care planning decision-making from both persons living with dementia and their shared decision-maker' points of view. The scale utilizes a Likert scale with values ranging from 1 (not confident at all) to 5 (very confident).
Time frame: Baseline
Population: SDMs and PLWDs in all study arms that completed the baseline interview were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWD: Control | Adapted Decision Making Confidence Scale | 4.8 score on a scale |
| SDMs: Control | Adapted Decision Making Confidence Scale | 4.7 score on a scale |
| PLWDs: Intervention | Adapted Decision Making Confidence Scale | 3.7 score on a scale |
| SDMs: Intervention | Adapted Decision Making Confidence Scale | 5 score on a scale |
Primary
Post Adapted Decision Making Confidence Scale
Items from the Surrogate Decision-Making Confidence Scale and 9-item ACP Engagement Survey were used and adapted to capture the confidence in advanced care planning decision-making from both persons living with dementia and their shared decision-maker' points of view. The scale utilizes a Likert scale with values ranging from 1 (not confident at all) to 5 (very confident). This is the second time point the measure was collected.
Time frame: 1 week
Population: 1 PLWD from the control group and 1 SDM from the Intervention group were lost to follow up. Data was not collected at this timepoint and so were not analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWD: Control | Post Adapted Decision Making Confidence Scale | 4.9 units on a scale |
| SDMs: Control | Post Adapted Decision Making Confidence Scale | 4.7 units on a scale |
| PLWDs: Intervention | Post Adapted Decision Making Confidence Scale | 4.25 units on a scale |
| SDMs: Intervention | Post Adapted Decision Making Confidence Scale | 5 units on a scale |
Primary
Rate of ACP Website Completion - Questions Completed
This tool measured what percentage of the website was completed by participants. Because SDMs navigated the website with the PLWD alongside them, this measure was only associated with SDMs in the intervention group.
Time frame: 1 week
Population: Percentage of website completed was captured for SDMs as they were primary navigators of the website.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWD: Control | Rate of ACP Website Completion - Questions Completed | 69 percentage of website completed |
Primary
Rate of ACP Website Completion - Time
This tool measured total time spent by participants on the advance care planning website. Total time in minutes spent on the website were collected. Because SDMs navigated the website with the PLWD alongside them, this measure was only used to SDMs in the intervention group.
Time frame: 1 week
Population: Total time SDMs spent navigating the Our Memory Care Wishes website was captured for each SDM in the intervention group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWD: Control | Rate of ACP Website Completion - Time | 42.93 minutes |
Primary
Website Ease of Use
This scale measures the ease of use of the website. This scale uses a Likert scale from 0 (very hard) to 10 (very easy). These data were collected from PLWDs and SDMs in the intervention group.
Time frame: 1 week
Population: SDMs tended to navigate the website and use the website to facilitate advanced care planning discussions with PLWDs. PLWDs participated in conversations about advanced care planning decisions but often did not actively use the website and so were not always able to answer or understand the questions regarding the website. In the end, only one PLWD from the intervention group was able to answer the questions about the website's ease of use. Thus, the score below indicates that PLWD's rating.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PLWD: Control | Website Ease of Use | 7 score on a scale |
| SDMs: Control | Website Ease of Use | 9 score on a scale |
Other Pre-specified
COVID-19 Impact Questionnaire
Participants were asked if their healthcare preferences changed due to the COVID-19 pandemic. Items included: 1. Since COVID, planning for the future is: (1) less important (2) more important, or (3) the same 2. Since COVID, the sense of urgency to name a supportive decision maker has: (1) increased (2) decreased, or (3) remained the same. 3. Since COVID, my preferences for decisions about breathing machines (ventilators) have: (1) changed or (2) remained the same. 4. Since COVID, my preferences for going to the hospital for care versus receiving treatment in place have:(1) changed, or (2) remained the same.
Time frame: 1 week
Population: 1 PLWD in the control group was lost to follow up.~1 SDM in the control group was lost to follow up.~1 PLWD in the intervention group was lost to follow up.~1 SMD in the intervention group was lost to follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PLWD: Control | COVID-19 Impact Questionnaire | Participants who reported a change in importance level for planning for the future since COVID-19. | 1 Participants |
| PLWD: Control | COVID-19 Impact Questionnaire | Change in the sense of urgency to name a supportive decision maker since COVID-19 | 0 Participants |
| PLWD: Control | COVID-19 Impact Questionnaire | Participants who reported a change in breathing machine preferences since COVID-19. | 0 Participants |
| PLWD: Control | COVID-19 Impact Questionnaire | Participants whose preferences for going to the hospital for care versus receiving treatment changed | 0 Participants |
| SDMs: Control | COVID-19 Impact Questionnaire | Change in the sense of urgency to name a supportive decision maker since COVID-19 | 2 Participants |
| SDMs: Control | COVID-19 Impact Questionnaire | Participants who reported a change in breathing machine preferences since COVID-19. | 1 Participants |
| SDMs: Control | COVID-19 Impact Questionnaire | Participants whose preferences for going to the hospital for care versus receiving treatment changed | 1 Participants |
| SDMs: Control | COVID-19 Impact Questionnaire | Participants who reported a change in importance level for planning for the future since COVID-19. | 1 Participants |
| PLWDs: Intervention | COVID-19 Impact Questionnaire | Participants who reported a change in breathing machine preferences since COVID-19. | 0 Participants |
| PLWDs: Intervention | COVID-19 Impact Questionnaire | Change in the sense of urgency to name a supportive decision maker since COVID-19 | 0 Participants |
| PLWDs: Intervention | COVID-19 Impact Questionnaire | Participants whose preferences for going to the hospital for care versus receiving treatment changed | 0 Participants |
| PLWDs: Intervention | COVID-19 Impact Questionnaire | Participants who reported a change in importance level for planning for the future since COVID-19. | 1 Participants |
| SDMs: Intervention | COVID-19 Impact Questionnaire | Participants whose preferences for going to the hospital for care versus receiving treatment changed | 1 Participants |
| SDMs: Intervention | COVID-19 Impact Questionnaire | Change in the sense of urgency to name a supportive decision maker since COVID-19 | 1 Participants |
| SDMs: Intervention | COVID-19 Impact Questionnaire | Participants who reported a change in importance level for planning for the future since COVID-19. | 1 Participants |
| SDMs: Intervention | COVID-19 Impact Questionnaire | Participants who reported a change in breathing machine preferences since COVID-19. | 1 Participants |