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

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ClinicalTrials.gov Identifier: NCT01565642
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 2, 2016
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

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

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

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Quality of communication and decision-making [ Time Frame: 3 months ]

    Composite outcome:

    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.



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.

  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.

  3. Comfort in dying [ Time Frame: 9 months ]
    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.

  4. Quality of life [ Time Frame: 9 months ]
    Quality of Life in Late-Stage Dementia scale (QUALID) rating of 11 items, scores range 12-45

  5. Quality of dying [ Time Frame: 9 months ]
    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.

  6. Frequency of communication [ Time Frame: 9 months ]
    Number of 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 ]
    Frequency and timing of referral to hospice services

  8. Hospitalizations [ Time Frame: 9 months ]
    Number and timing of transfer to hospital from nursing home care



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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

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
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
Principal Investigator: Laura C Hanson, MD, MPH University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01565642     History of Changes
Other Study ID Numbers: 10-0699
R01AG037483 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016

Keywords provided by University of North Carolina, Chapel Hill:
Dementia, decision making

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders