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

This study is currently recruiting participants.
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01565642
First received: March 26, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention
Dementia
Behavioral: Goals of care decision support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Quality of communication and decision-making [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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:
  • Number of palliative care domains in care plan [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with care [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • Comfort in dying [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • Quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Quality of Life in Late-Stage Dementia scale (QUALID) rating of 11 items, scores range 12-45

  • Quality of dying [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • Frequency of communication [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Number of discussions of goals of care with providers -- physicians, nurse practitioners, physician assistants or nursing home staff -- counted during follow-up

  • Hospice referral [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Frequency and timing of referral to hospice services

  • Hospitalizations [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Number and timing of transfer to hospital from nursing home care


Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565642

Contacts
Contact: Laura Hanson 919-966-5945

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Robin Gilliam    919-966-7503    rgilliam@schsr.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Laura C Hanson, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01565642     History of Changes
Other Study ID Numbers: 10-0699, R01AG037483
Study First Received: March 26, 2012
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014