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

• 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: University of North Carolina, Chapel Hill
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Tracking Information

• First Submitted Date: March 26, 2012
• First Posted Date: March 28, 2012
• Results First Submitted Date: May 25, 2018
• Results First Posted Date: August 10, 2018
• Last Update Posted Date: August 10, 2018
• Study Start Date: May 2012
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 9, 2018)

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.

Original Primary Outcome Measures (submitted: March 26, 2012)

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.

Current Secondary Outcome Measures (submitted: July 9, 2018)

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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
• Official Title: Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Dementia

Intervention

Behavioral: Goals of care decision support

Decision aid and care plan meeting

Study Arms

• Experimental: Decision support intervention
  Decision aid and care plan meeting
  Intervention: Behavioral: Goals of care decision support
• No Intervention: Control
  Attention control information on dementia care

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2016): 302
• Original Estimated Enrollment (submitted: March 26, 2012): 300
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01565642
• Other Study ID Numbers: 10-0699; R01AG037483 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of North Carolina, Chapel Hill
• Original Responsible Party: Same as current
• Current Study Sponsor: University of North Carolina, Chapel Hill
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Aging (NIA)

Investigators

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

• PRS Account: University of North Carolina, Chapel Hill
• Verification Date: March 2016