Dementia
Conditions
Keywords
Dementia, decision making
Brief summary
This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.
Interventions
BEHAVIORALGoals of care decision support
Decision aid and care plan meeting
Sponsors
National Institute on Aging (NIA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia
Exclusion criteria
* Non-related legal surrogate without personal knowledge of resident
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Communication and Decision-making | 3 months | The Quality of Communication (QOC) score with its End of Life (EOL) subscale score. Scores range 0-10 on QOC and its subscales, with higher scores indicating better communication quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Care | 9 months | Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) scale; 10 items rated 1-4 and summed with total potential range 10-40. Higher scores indicate better satisfaction. |
| Comfort in Dying | 9 months | Comfort Assessment in Dying for Dementia (CAD-EOLD) includes 14 items rated on a 3 point scale, summed for a total potential score of 14-42. Higher scores indicate better comfort. |
| Alzheimer Disease Related Quality of Life | 9 months | The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life. |
| Number of Palliative Care Domains in Care Plan | 9 months | Index score ranging from 0-10 with one point given for care plan addressing each domain: prognosis, goals of care, physical symptoms, emotional needs, spiritual needs, resuscitation, artificial feeding, intravenous fluids, antibiotics, hospitalization. Higher scores indicate better palliative care. |
| Frequency of Communication | 9 months | Number of participants who report discussions of goals of care with providers -- physicians, nurse practitioners, physician assistants or nursing home staff -- counted during follow-up |
| Hospice Referral | 9 months | Number of participants with a referral to hospice services |
| Hospitalizations | 9 months | Number and timing of transfer to hospital from nursing home care, measured as hospital transfers per 90 person-days of follow-up, with follow-up censored at death. |
| Quality of Dying | 9 months | Quality of Dying in Long-term Care (QOD-LTC) instrument has 11 items in 3 subscales measuring personhood, closure and preparation for dying, for total scores ranging 5-55. Higher scores indicate better quality of the dying experience. |
Countries
United States
Participant flow
Recruitment details
April 2012 to September 2014 enrolled dyads of persons with advanced dementia and family decision-makers from 22 participating nursing home sites.
Participants by arm
| Arm | Count |
|---|---|
| Decision Support Intervention Decision aid and care plan meeting
Goals of care decision support: Decision aid and care plan meeting | 151 |
| Control Attention control information on dementia care | 151 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Decision Support Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 85.7 years STANDARD_DEVIATION 7.6 | 87.3 years STANDARD_DEVIATION 6.7 | 86.5 years STANDARD_DEVIATION 6.9 |
| Dementia Stage: Global Deterioration Scale (GDS) GDS 5 | 38 Participants | 36 Participants | 74 Participants |
| Dementia Stage: Global Deterioration Scale (GDS) GDS 6 | 79 Participants | 73 Participants | 152 Participants |
| Dementia Stage: Global Deterioration Scale (GDS) GDS 7 | 34 Participants | 42 Participants | 76 Participants |
| Race/Ethnicity, Customized Race African American | 14 Participants | 25 Participants | 39 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 134 Participants | 123 Participants | 257 Participants |
| Region of Enrollment United States | 151 Participants | 151 Participants | 302 Participants |
| Sex: Female, Male Female | 121 Participants | 125 Participants | 246 Participants |
| Sex: Female, Male Male | 30 Participants | 26 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 151 | 33 / 151 |
| other Total, other adverse events | 0 / 151 | 0 / 151 |
| serious Total, serious adverse events | 0 / 151 | 0 / 151 |
Outcome results
Primary
Quality of Communication and Decision-making
The Quality of Communication (QOC) score with its End of Life (EOL) subscale score. Scores range 0-10 on QOC and its subscales, with higher scores indicating better communication quality.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Support Intervention | Quality of Communication and Decision-making | QOC score | 6.0 units on a scale | Standard Deviation 2 |
| Decision Support Intervention | Quality of Communication and Decision-making | QOC End of Life score | 3.7 units on a scale | Standard Deviation 2.7 |
| Control | Quality of Communication and Decision-making | QOC score | 5.6 units on a scale | Standard Deviation 1.8 |
| Control | Quality of Communication and Decision-making | QOC End of Life score | 3.0 units on a scale | Standard Deviation 2.6 |
Secondary
Alzheimer Disease Related Quality of Life
The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.
Time frame: 9 months
Population: This measure applies only to those persons with dementia who remained alive through the 9 month follow-up. In addition there were 3 withdrawals from the study by 9 months. Thus the overall number of participants for this outcome measure are n=239 (n=302 after removal of 60 decedents and 3 withdrawn participants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Intervention | Alzheimer Disease Related Quality of Life | 67.8 units on a scale | Standard Deviation 15.9 |
| Control | Alzheimer Disease Related Quality of Life | 65.9 units on a scale | Standard Deviation 16.8 |
Secondary
Comfort in Dying
Comfort Assessment in Dying for Dementia (CAD-EOLD) includes 14 items rated on a 3 point scale, summed for a total potential score of 14-42. Higher scores indicate better comfort.
Time frame: 9 months
Population: Decedents only--this outcome measure applies only to residents who die during Follow-Up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Intervention | Comfort in Dying | 34.0 units on a scale | Standard Deviation 5.7 |
| Control | Comfort in Dying | 32.7 units on a scale | Standard Deviation 5.4 |
Secondary
Frequency of Communication
Number of participants who report discussions of goals of care with providers -- physicians, nurse practitioners, physician assistants or nursing home staff -- counted during follow-up
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Support Intervention | Frequency of Communication | 121 Participants |
| Control | Frequency of Communication | 123 Participants |
Secondary
Hospice Referral
Number of participants with a referral to hospice services
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Support Intervention | Hospice Referral | 17 Participants |
| Control | Hospice Referral | 18 Participants |
Secondary
Hospitalizations
Number and timing of transfer to hospital from nursing home care, measured as hospital transfers per 90 person-days of follow-up, with follow-up censored at death.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision Support Intervention | Hospitalizations | 0.08 Hospital transfers per 90 person-days |
| Control | Hospitalizations | 0.16 Hospital transfers per 90 person-days |
Secondary
Number of Palliative Care Domains in Care Plan
Index score ranging from 0-10 with one point given for care plan addressing each domain: prognosis, goals of care, physical symptoms, emotional needs, spiritual needs, resuscitation, artificial feeding, intravenous fluids, antibiotics, hospitalization. Higher scores indicate better palliative care.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Intervention | Number of Palliative Care Domains in Care Plan | 5.9 units on a scale | Standard Deviation 2.2 |
| Control | Number of Palliative Care Domains in Care Plan | 5.3 units on a scale | Standard Deviation 1.9 |
Secondary
Quality of Dying
Quality of Dying in Long-term Care (QOD-LTC) instrument has 11 items in 3 subscales measuring personhood, closure and preparation for dying, for total scores ranging 5-55. Higher scores indicate better quality of the dying experience.
Time frame: 9 months
Population: Decedents only--this measure applies only to residents who die during Follow-Up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Intervention | Quality of Dying | 41.7 units on a scale | Standard Deviation 7.1 |
| Control | Quality of Dying | 41.7 units on a scale | Standard Deviation 7.1 |
Secondary
Satisfaction With Care
Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) scale; 10 items rated 1-4 and summed with total potential range 10-40. Higher scores indicate better satisfaction.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Intervention | Satisfaction With Care | 31.0 units on a scale | Standard Deviation 5.9 |
| Control | Satisfaction With Care | 31.6 units on a scale | Standard Deviation 5.3 |