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
Last Update Posted : March 2, 2016
|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 + Concordance on goals of care defined as the percent of surrogates that report a primary goal identical to providers + the Advance Care Planning problem score from the Toolkit Family Interview. It consists of 3 items assigned one desired answer; a "problem score" is calculated as percent of respondents giving a non-desired answer to one item.
- 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.
- 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.
- Comfort in dying [ Time Frame: 9 months ]This outcome measure applies only to residents who die during follow-up. 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.
- Quality of life [ Time Frame: 9 months ]Quality of Life in Late-Stage Dementia scale (QUALID) rating of 11 items, scores range 12-45
- Quality of dying [ Time Frame: 9 months ]This measure applies only to residents who die during follow-up. 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.
- Frequency of communication [ Time Frame: 9 months ]Number of 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 ]Frequency and timing of referral to hospice services
- Hospitalizations [ Time Frame: 9 months ]Number and timing of transfer to hospital from nursing home care
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|