Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia (GOC)
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|ClinicalTrials.gov Identifier: NCT01565642|
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: Goals of care decision support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Decision support intervention
Decision aid and care plan meeting
Behavioral: Goals of care decision support
Decision aid and care plan meeting
No Intervention: Control
Attention control information on dementia care
- Quality of Communication and Decision-making [ Time Frame: 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.
- Number of Palliative Care Domains in Care Plan [ Time Frame: 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.
- Satisfaction With Care [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 9 months ]The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.
- Quality of Dying [ Time Frame: 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.
- Frequency of Communication [ Time Frame: 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 [ Time Frame: 9 months ]Number of participants with a referral to hospice services
- Hospitalizations [ Time Frame: 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.
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|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia
- Non-related legal surrogate without personal knowledge of resident
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565642
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Laura C Hanson, MD, MPH||University of North Carolina, Chapel Hill|
|Responsible Party:||University of North Carolina, Chapel Hill|
|Other Study ID Numbers:||
R01AG037483 ( U.S. NIH Grant/Contract )
|First Posted:||March 28, 2012 Key Record Dates|
|Results First Posted:||August 10, 2018|
|Last Update Posted:||August 10, 2018|
|Last Verified:||March 2016|
Dementia, decision making
Central Nervous System Diseases
Nervous System Diseases