Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia (GOC)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia|
- Quality of communication and decision-making [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Quality of Life in Late-Stage Dementia scale (QUALID) rating of 11 items, scores range 12-45
- Quality of dying [ Time Frame: 9 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Frequency and timing of referral to hospice services
- Hospitalizations [ Time Frame: 9 months ] [ Designated as safety issue: No ]Number and timing of transfer to hospital from nursing home care
|Study Start Date:||May 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|