Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia (GOC)
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.
|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|
|Estimated Primary Completion Date:||June 2016 (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
|Contact: Laura Hanson||919-966-5945|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Robin Gilliam 919-966-7503 email@example.com|
|Principal Investigator:||Laura C Hanson, MD, MPH||University of North Carolina, Chapel Hill|