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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goals of care decision support
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Dementia, decision making

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Decision support intervention

Control

Arm Description

Decision aid and care plan meeting

Attention control information on dementia care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
Hospice Referral
Number of participants with a referral to hospice services
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.

Full Information

First Posted
March 26, 2012
Last Updated
July 9, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01565642
Brief Title
Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
Acronym
GOC
Official Title
Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, decision making

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision support intervention
Arm Type
Experimental
Arm Description
Decision aid and care plan meeting
Arm Title
Control
Arm Type
No Intervention
Arm Description
Attention control information on dementia care
Intervention Type
Behavioral
Intervention Name(s)
Goals of care decision support
Intervention Description
Decision aid and care plan meeting
Primary Outcome Measure Information:
Title
Quality of Communication and Decision-making
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Palliative Care Domains in Care Plan
Description
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.
Time Frame
9 months
Title
Satisfaction With Care
Description
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.
Time Frame
9 months
Title
Comfort in Dying
Description
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.
Time Frame
9 months
Title
Alzheimer Disease Related Quality of Life
Description
The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.
Time Frame
9 months
Title
Quality of Dying
Description
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.
Time Frame
9 months
Title
Frequency of Communication
Description
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
Time Frame
9 months
Title
Hospice Referral
Description
Number of participants with a referral to hospice services
Time Frame
9 months
Title
Hospitalizations
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura C Hanson, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29957095
Citation
Ernecoff NC, Zimmerman S, Mitchell SL, Song MK, Lin FC, Wessell KL, Hanson LC. Concordance between Goals of Care and Treatment Decisions for Persons with Dementia. J Palliat Med. 2018 Oct;21(10):1442-1447. doi: 10.1089/jpm.2018.0103. Epub 2018 Jun 29.
Results Reference
derived
PubMed Identifier
27893884
Citation
Hanson LC, Zimmerman S, Song MK, Lin FC, Rosemond C, Carey TS, Mitchell SL. Effect of the Goals of Care Intervention for Advanced Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jan 1;177(1):24-31. doi: 10.1001/jamainternmed.2016.7031.
Results Reference
derived
PubMed Identifier
27271683
Citation
Hanson LC, Song MK, Zimmerman S, Gilliam R, Rosemond C, Chisholm L, Lin FC. Fidelity to a behavioral intervention to improve goals of care decisions for nursing home residents with advanced dementia. Clin Trials. 2016 Dec;13(6):599-604. doi: 10.1177/1740774516650863. Epub 2016 Jun 7.
Results Reference
derived

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

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