Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia

Dementia Clinical Trial

— GOC  

Official title:

Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565642
• Other study ID #: 10-0699
• Secondary ID: R01AG037483
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia

Exclusion Criteria:

• Non-related legal surrogate without personal knowledge of resident

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Goals of care decision support
Decision aid and care plan meeting

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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.	9 months
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	9 months
Secondary	Hospice Referral	Number of participants with a referral to hospice services	9 months
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.	9 months