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

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Goals of care decision support

• Registration Number: NCT01565642
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Study Start: 2012-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-03
• Results First Submitted: 2018-05-25
• Results First Submitted QC: 2018-07-09
• Last Update Submitted: 2018-07-09
• Results First Posted: 2018-08-10
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

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

Read More

Exclusion Criteria

• Non-related legal surrogate without personal knowledge of resident

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision support intervention	Goals of care decision support	Decision aid and care plan meeting

Primary Outcome Measures

Name	Time	Method
Quality of Communication and Decision-making	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Care	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.
Number of Palliative Care Domains in Care Plan	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.
Comfort in Dying	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	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	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	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
Hospitalizations	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.
Hospice Referral	9 months	Number of participants with a referral to hospice services

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States