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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG037483 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision support intervention | Experimental | Decision aid and care plan meeting |
|
| Control | No Intervention | Attention control information on dementia care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goals of care decision support | Behavioral | Decision aid and care plan meeting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura C Hanson, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29957095 | Derived | Ernecoff NC, Zimmerman S, Mitchell SL, Song MK, Lin FC, Wessell KL, Hanson LC. Concordance between Goals of Care and Treatment Decisions for Persons with Dementia. J Palliat Med. 2018 Oct;21(10):1442-1447. doi: 10.1089/jpm.2018.0103. Epub 2018 Jun 29. | |
| 27893884 | Derived | Hanson LC, Zimmerman S, Song MK, Lin FC, Rosemond C, Carey TS, Mitchell SL. Effect of the Goals of Care Intervention for Advanced Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jan 1;177(1):24-31. doi: 10.1001/jamainternmed.2016.7031. |
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April 2012 to September 2014 enrolled dyads of persons with advanced dementia and family decision-makers from 22 participating nursing home sites.
| ID | Title | Description |
|---|---|---|
| FG000 | Decision Support Intervention | Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting |
| FG001 | Control | Attention control information on dementia care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Support Intervention | Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting |
| BG001 | Control | Attention control information on dementia care |
| 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, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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 | Decision Support Intervention | Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura C. Hanson, MD, MPH | University of North Carolina at Chapel Hill | 919-843-4096 | lhanson@med.unc.edu |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 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. | 9 months |
| 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. | 9 months |
| 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. | 9 months |
| 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. | 9 months |
| 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 | 9 months |
| Hospice Referral | Number of participants with a referral to hospice services | 9 months |
| 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. | 9 months |
| 27271683 | Derived | Hanson LC, Song MK, Zimmerman S, Gilliam R, Rosemond C, Chisholm L, Lin FC. Fidelity to a behavioral intervention to improve goals of care decisions for nursing home residents with advanced dementia. Clin Trials. 2016 Dec;13(6):599-604. doi: 10.1177/1740774516650863. Epub 2016 Jun 7. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Dementia Stage: Global Deterioration Scale (GDS) | The Global deterioration scale includes seven different diagnostic stages ranging between "no cognitive deterioration" and "very serious cognitive deterioration." It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline) with higher scores reflecting greater severity of cognitive deterioration. | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| 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. | Decedents only--this outcome measure applies only to residents who die during Follow-Up. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| 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. | Decedents only--this measure applies only to residents who die during Follow-Up. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| 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 | Posted | Count of Participants | Participants | 9 months |
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| Secondary | Hospice Referral | Number of participants with a referral to hospice services | Posted | Count of Participants | Participants | 9 months |
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| 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. | Posted | Number | Hospital transfers per 90 person-days | 9 months |
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| 27 |
| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | Control | Attention control information on dementia care | 33 | 151 | 0 | 151 | 0 | 151 |
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| D001523 | Mental Disorders |