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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064105-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants who are allocated to the control arm will complete baseline measures and then receive usual advanced care planning care and discussions with the nursing facility staff. Control arm participants will not review the Our Memory Care Wishes website. Participants will complete follow up measures one week after the baseline interview. | |
| Intervention | Experimental | Participants allocated to the intervention group will complete baseline measures. Then, the participant will review the Our Memory Care Wishes website and enter advanced care planning decisions and preferences into the website. Participants will complete follow up measures one week after the baseline interview. Participants receiving the intervention will complete additional follow up measures which include surveys measuring the ease of use of the website. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Our Memory Care Wishes | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
| 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. | 1 week |
| 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. | 1 week |
| 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. | 1 week |
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Impact Questionnaire | Participants were asked if their healthcare preferences changed due to the COVID-19 pandemic. Items included:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4217 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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PLWDs and their SDMs in control and intervention study arms met with study staff and nursing home staff to complete baseline interviews. At baseline, demographics and confidence levels in decision-making were collected for both SDMs and PLWDs.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | SDMs and PLWDs in all study arms that completed the baseline interview were analyzed. | Posted | Mean | Full Range | score on a scale | Baseline |
|
10 months
14 out of 14 participants analyzed. No adverse events occured.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Summerhayes | The University of Pennsylvania School of Nursing | 6099233786 | esummer@nursing.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2021 | Apr 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| 1 week |
| 1 week |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
| OG002 | PLWDs: 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. Our 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. |
| OG003 | 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. |
|
|
| 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. | 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. | Posted | Mean | Full Range | units on a scale | 1 week |
|
|
|
| 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. | 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. | Posted | Mean | Full Range | score on a scale | 1 week |
|
|
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| 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. | Total time SDMs spent navigating the Our Memory Care Wishes website was captured for each SDM in the intervention group. | Posted | Mean | Full Range | minutes | 1 week |
|
|
|
| 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. | Percentage of website completed was captured for SDMs as they were primary navigators of the website. | Posted | Mean | Full Range | percentage of website completed | 1 week |
|
|
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| Other Pre-specified | COVID-19 Impact Questionnaire | Participants were asked if their healthcare preferences changed due to the COVID-19 pandemic. Items included:
| 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. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Intervention | Our 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change in the sense of urgency to name a supportive decision maker since COVID-19 |
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| Participants who reported a change in breathing machine preferences since COVID-19. |
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| Participants whose preferences for going to the hospital for care versus receiving treatment changed |
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