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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014