Health Communication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMe & 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.
Sponsors
Brown University
National Institute on Aging (NIA)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Resident Inclusion Criteria: * Identified as having Alzheimer's or related dementia * Mild to moderate cognitive impairment (BIMS = 8-15, (MDS C0500) (nursing home residents only) * Makes Self Understood = \<1 (MDS B0700)/present in medical record * Understood By Others = \<1 (MDS B0800)/present in medical record * Reside at the facility at least 2 weeks identified as a long-term resident * Age \>65 years * Speaks English Family Inclusion Criteria: * Speaks English * Willing and able to watch the videos * Willing to complete short surveys. Being unable to attend care conference to view the video (e.g. due to distance) will not exclude family from participating. Staff Inclusion Criteria: * Speaks English * Willing to watch the videos * Willing to complete short surveys Resident
Exclusion criteria
* Limited communication capacity (e.g. aphasia) * Comatose * Cognitively intact * Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Documented Discussion of Goals of Care | Baseline, time of sharing (3 months from baseline), and 90 days post sharing video | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for Communicating Preferences | Baseline, time of sharing (3 months from baseline), and 90 days post sharing video | Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Psychosocial Preferences Between Video and Staff | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video | 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. |
| Concordance of End of Life Preferences, Video and Staff | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video | 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. |
| Concordance of Psychosocial Preferences, Video and Family | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video | 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. |
| Concordance of End of Life Preferences, Video and Family | Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 19 |
| 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. | 25 |
| 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. | 25 |
| 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. | 13 |
| 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. | 25 |
| Total | 124 |
Baseline characteristics
| Characteristic | Me & My Wishes Wait-list Control/Group 2 Residents | Me & My Wishes Intervention/Group 1 Family | Me & My Wishes Wait-list Control/Group 2 Family | Me & My Wishes Intervention/Group 1 Staff | Me & My Wishes Wait-list Control/Group 2 Staff | Me & My Wishes Intervention/Group 1 Residents | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 8 Participants | 12 Participants | 0 Participants | 3 Participants | 17 Participants | 59 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 17 Participants | 13 Participants | 12 Participants | 21 Participants | 0 Participants | 63 Participants |
| Age, Continuous | 57.75 years STANDARD_DEVIATION 18.24 | 59.84 years STANDARD_DEVIATION 10.15 | 61.56 years STANDARD_DEVIATION 12.88 | 47.33 years STANDARD_DEVIATION 10.97 | 41.58 years STANDARD_DEVIATION 16.83 | 64.77 years STANDARD_DEVIATION 17.31 | 60.86 years STANDARD_DEVIATION 18.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 24 Participants | 24 Participants | 13 Participants | 23 Participants | 16 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 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 | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 25 Participants | 24 Participants | 13 Participants | 19 Participants | 14 Participants | 113 Participants |
| Region of Enrollment United States | 19 Participants | 25 Participants | 25 Participants | 13 Participants | 25 Participants | 17 Participants | 124 Participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 21 Participants | 12 Participants | 20 Participants | 9 Participants | 90 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 4 Participants | 1 Participants | 5 Participants | 8 Participants | 34 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 26 | 1 / 24 | 0 / 25 | 0 / 25 | 0 / 13 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 13 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 13 | 0 / 25 |
Outcome results
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
Time frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Population: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Me & My WishesIntervention/Group 1 Resident | Number of Participants With a Documented Discussion of Goals of Care | 12 Participants |
| Me & My Wishes Wait-list Control/Group 2 Resident | Number of Participants With a Documented Discussion of Goals of Care | 10 Participants |
Comparison: Multilevel logistic regression (generalized estimating equations \[GEE\] with an autoregressive (1) working correlation matrix, logit link function) were fitted to assess the primary hypotheses. The models account for the repeated measures (3 or 4 time points), correlated, data structure per person. An additive model was conducted with contrast coding for each time point, treatment, and follow-up effects.p-value: 0.10595% CI: [0.78, 14.15]Mixed Models Analysis
Secondary
Self-efficacy for Communicating Preferences
Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident.
Time frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Population: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Me & My WishesIntervention/Group 1 Resident | Self-efficacy for Communicating Preferences | Time of sharing | 4.37 score on a scale | Standard Error 0.15 |
| Me & My WishesIntervention/Group 1 Resident | Self-efficacy for Communicating Preferences | Baseline | 4.26 score on a scale | Standard Error 0.13 |
| Me & My WishesIntervention/Group 1 Resident | Self-efficacy for Communicating Preferences | 90 day | 4.38 score on a scale | Standard Error 0.16 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Self-efficacy for Communicating Preferences | Baseline | 4.26 score on a scale | Standard Error 0.13 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Self-efficacy for Communicating Preferences | Time of sharing | 3.77 score on a scale | Standard Error 0.26 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Self-efficacy for Communicating Preferences | 90 day | 3.96 score on a scale | Standard Error 0.25 |
p-value: 0.0495% CI: [0.022, 1.178]Mixed Models Analysis
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.
Time frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Population: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Me & My WishesIntervention/Group 1 Resident | Concordance of End of Life Preferences, Video and Family | Baseline | 48.15 percentage of agreement | Standard Deviation 23.04 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of End of Life Preferences, Video and Family | Time of Sharing | 60.80 percentage of agreement | Standard Deviation 23.44 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of End of Life Preferences, Video and Family | 90 days | 53.91 percentage of agreement | Standard Deviation 17.51 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of End of Life Preferences, Video and Family | Baseline | 38.26 percentage of agreement | Standard Deviation 35.63 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of End of Life Preferences, Video and Family | Time of Sharing | 62.61 percentage of agreement | Standard Deviation 26.49 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of End of Life Preferences, Video and Family | 90 days | 52.63 percentage of agreement | Standard Deviation 24.23 |
p-value: 0.03395% CI: [0.11, 0.3]Mixed Models Analysis
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.
Time frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Population: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Me & My WishesIntervention/Group 1 Resident | Concordance of End of Life Preferences, Video and Staff | Baseline | 29.79 percentage of agreement | Standard Deviation 24.98 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of End of Life Preferences, Video and Staff | Time of Sharing | 63.50 percentage of agreement | Standard Deviation 22.59 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of End of Life Preferences, Video and Staff | 90 days | 60.93 percentage of agreement | Standard Deviation 23.07 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of End of Life Preferences, Video and Staff | Baseline | 27.18 percentage of agreement | Standard Deviation 25.37 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of End of Life Preferences, Video and Staff | Time of Sharing | 55.29 percentage of agreement | Standard Deviation 28.17 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of End of Life Preferences, Video and Staff | 90 days | 46.27 percentage of agreement | Standard Deviation 28.7 |
p-value: 0.00195% CI: [0.21, 0.48]Mixed Models Analysis
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.
Time frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Population: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Me & My WishesIntervention/Group 1 Resident | Concordance of Psychosocial Preferences Between Video and Staff | Baseline | 47.87 percentage of agreement | Standard Deviation 29.87 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of Psychosocial Preferences Between Video and Staff | Time of Sharing | 77.50 percentage of agreement | Standard Deviation 19.45 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of Psychosocial Preferences Between Video and Staff | 90 days | 68.60 percentage of agreement | Standard Deviation 24.45 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of Psychosocial Preferences Between Video and Staff | Baseline | 44.87 percentage of agreement | Standard Deviation 31.82 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of Psychosocial Preferences Between Video and Staff | Time of Sharing | 87.25 percentage of agreement | Standard Deviation 18.28 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of Psychosocial Preferences Between Video and Staff | 90 days | 60.29 percentage of agreement | Standard Deviation 30.49 |
p-value: 0.00195% CI: [0.12, 0.46]Mixed Models Analysis
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.
Time frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Population: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Me & My WishesIntervention/Group 1 Resident | Concordance of Psychosocial Preferences, Video and Family | Baseline | 67.31 percentage of agreement | Standard Deviation 24.26 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of Psychosocial Preferences, Video and Family | Time of Sharing | 72.00 percentage of agreement | Standard Deviation 22.03 |
| Me & My WishesIntervention/Group 1 Resident | Concordance of Psychosocial Preferences, Video and Family | 90 days | 71.74 percentage of agreement | Standard Deviation 24.2 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of Psychosocial Preferences, Video and Family | Baseline | 64.13 percentage of agreement | Standard Deviation 30.92 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of Psychosocial Preferences, Video and Family | Time of Sharing | 83.70 percentage of agreement | Standard Deviation 23.37 |
| Me & My Wishes Wait-list Control/Group 2 Resident | Concordance of Psychosocial Preferences, Video and Family | 90 days | 85.53 percentage of agreement | Standard Deviation 19.21 |
p-value: 0.08195% CI: [-0.01, 0.19]Mixed Models Analysis