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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG058094 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brown University | OTHER |
| National Institute on Aging (NIA) | NIH |
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The aim of this study is to determine whether the Me & My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team.
Me & My Wishes are videos of nursing home residents talking about their preferences for care, including four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Knowing what residents want is essential to staff's ability to provide quality care and can inform family caregivers decision making especially in later stages of life as the resident's cognition declines-a time when family caregivers often feel unprepared. Persons with mild to moderate dementia can accurately express their everyday and EOL preferences, however, stereotypes persist about the decision making abilities of people with dementia that often prevent their involvement in conversations about care. The investigators propose to conduct a Stage II efficacy trial of Me & My Wishes-a novel approach for communicating resident care preferences-by creating videos with 48-54 nursing home residents with mild to moderate dementia and sharing their personalized video with informal (family) and formal (staff) caregivers. The investigators will employ a randomized wait-list control design in which residents in control nursing homes will delay sharing their video. Videos may be viewed two ways: 1) in resident quarterly care conferences; and 2) via a web-based link with resident-identified family members or friends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Me & My Wishes Intervention/Group 1 | Experimental | In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline. |
|
| Me & My Wishes Wait-list control/Group 2 | Other | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Me & My Wishes | Behavioral | Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Documented Discussion of Goals of Care | At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point. Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions. Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused | Baseline, time of sharing (3 months from baseline), and 90 days post sharing video |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy for Communicating Preferences | Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident. | Baseline, time of sharing (3 months from baseline), and 90 days post sharing video |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of Psychosocial Preferences Between Video and Staff | Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched. |
Resident Inclusion Criteria:
Family Inclusion Criteria:
Staff Inclusion Criteria:
Resident Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marquis Hope Village Assisted Living | Canby | Oregon | 97209 | United States | ||
| Marquis Forest Grove Assisted Living |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34962157 | Derived | Towsley GL, Neller S, Baier RR, Wong B. Me & My Wishes: Concordance of End-of-Life Preferences between Residents with Dementia, Family, and Staff. J Palliat Med. 2022 Jun;25(6):880-887. doi: 10.1089/jpm.2021.0111. Epub 2021 Dec 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Me & My Wishes Intervention/Group 1 | In Group 1 (early intervention group) NHs, families, and staff video recording, editing, and viewing will occur within three months of baseline. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
| FG001 | Me & My Wishes Wait-list Control/Group 2 | In Group 2 (delayed sharing) NHs, residents, families, and staff will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Residents, family, and staff who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Me & My Wishes Intervention/Group 1 Residents | In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age not reported for two participants (e.g., left blank) |
| 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 | Number of Participants With a Documented Discussion of Goals of Care | At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point. Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions. Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused | persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities | Posted | Count of Participants | Participants | Baseline, time of sharing (3 months from baseline), and 90 days post sharing video |
|
baseline to end of study (6-9 months)
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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 | Me & My Wishes Intervention/Group 1 Resident | In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
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Randomization at site level and despite, randomizing in blocks, our sites differed. Small sample size: Primary outcome (goals of care conversations) without the power to detect statistical significance. Findings may be muted or underestimated because we measured documentation; conversations may occur without being documented. Majority of participants being of one racial group (white) and one geographic region limits generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gail Towsley | University of Utah | 801-585-9085 | gail.towsley@nurs.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2019 | Aug 30, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2019 | Nov 28, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2019 | Sep 19, 2019 | ICF_000.pdf |
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The investigators propose Stage II efficacy testing of Me & My Wishes using a randomized wait-list control design that allows the investigators to compare the effects between an early intervention group (Group 1) and a wait-list "control" group (Group 2).Six NHs matched on number of beds and payor mix will be randomly assigned to one of two groups.
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|
| Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
| Concordance of End of Life Preferences, Video and Staff | EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched. | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
| Concordance of Psychosocial Preferences, Video and Family | Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched. | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
| Concordance of End of Life Preferences, Video and Family | EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched. | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
| Forest Grove |
| Oregon |
| 97116 |
| United States |
| Marquis Forest Grove Post Acute Rehab | Forest Grove | Oregon | 97116 | United States |
| Regency Gresham Nursing and Rehabilitation Center | Gresham | Oregon | 97080 | United States |
| Marquis Wilsonville Assisted Living | Wilsonville | Oregon | 97070 | United States |
| Marquis Wilsonville Post Acute Rehab | Wilsonville | Oregon | 97070 | United States |
| French Prairie Nursing and Rehab | Woodburn | Oregon | 97071 | United States |
| Woodland Care Center | Woodland | Washington | 98674 | United States |
| BG001 | Me & My Wishes Wait-list Control/Group 2 Residents | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
| BG002 | Me & My Wishes Intervention/Group 1 Family | In Group 1 (early intervention group) NHs, resident's video will be shared within three months of baseline. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared. |
| BG003 | Me & My Wishes Wait-list Control/Group 2 Family | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be shared with family within three months. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared. |
| BG004 | Me & My Wishes Intervention/Group 1 Staff | In Group 1 (early intervention group) NHs, resident's video will be shared with staff within three months of baseline. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared. |
| BG005 | Me & My Wishes Wait-list Control/Group 2 Staff | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be shared with staff within three months. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared. |
| BG006 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
| OG001 | Me & My Wishes Wait-list Control/Group 2 Resident | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. |
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| Secondary | Self-efficacy for Communicating Preferences | Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident. | persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities. | Posted | Mean | Standard Error | score on a scale | Baseline, time of sharing (3 months from baseline), and 90 days post sharing video |
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|
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| Other Pre-specified | Concordance of Psychosocial Preferences Between Video and Staff | Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched. | persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities. | Posted | Mean | Standard Deviation | percentage of agreement | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
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|
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| Other Pre-specified | Concordance of End of Life Preferences, Video and Staff | EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched. | persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities. | Posted | Mean | Standard Deviation | percentage of agreement | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
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| Other Pre-specified | Concordance of Psychosocial Preferences, Video and Family | Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched. | persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities. | Posted | Mean | Standard Deviation | percentage of agreement | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
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| Other Pre-specified | Concordance of End of Life Preferences, Video and Family | EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched. | persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities. | Posted | Mean | Standard Deviation | percentage of agreement | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video |
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|
|
|
| 2 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Me & My Wishes Wait-list Control/Group 2 Resident | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. Me & My Wishes: Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. | 1 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Me & My Wishes Intervention/Group 1 Family | In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline with family. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Me & My Wishes Wait-list Family | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months with family. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG004 | Me & My Wishes Intervention Group 1 Staff | In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline with staff | 0 | 13 | 0 | 13 | 0 | 13 |
| EG005 | Me & My Wishes Control/Group 2 Staff | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months with staff | 0 | 25 | 0 | 25 | 0 | 25 |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 90 day |
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| 90 days |
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| 90 days |
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| 90 days |
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| 90 days |
|