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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565642
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Goals of care decision support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
Study Start Date : May 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Communication and Decision-making [ Time Frame: 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 :
  1. Number of Palliative Care Domains in Care Plan [ Time Frame: 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.

  2. Satisfaction With Care [ Time Frame: 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.

  3. Comfort in Dying [ Time Frame: 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.

  4. Alzheimer Disease Related Quality of Life [ Time Frame: 9 months ]
    The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.

  5. Quality of Dying [ Time Frame: 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.

  6. Frequency of Communication [ Time Frame: 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

  7. Hospice Referral [ Time Frame: 9 months ]
    Number of participants with a referral to hospice services

  8. Hospitalizations [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565642


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Laura C Hanson, MD, MPH University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01565642    
Other Study ID Numbers: 10-0699
R01AG037483 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2012    Key Record Dates
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018
Last Verified: March 2016
Keywords provided by University of North Carolina, Chapel Hill:
Dementia, decision making
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders