DementiaGOCNCT01565642
Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
A study testing Goals of care decision support in people with Dementia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Goals of care decision support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia
Who cannot join
- Non-related legal surrogate without personal knowledge of resident
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
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.
- Conditions
- Dementia
- Being tested
- Goals of care decision support
- Keywords
- Dementia, decision making
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goals of care decision supportBehavioural
Decision aid and care plan meeting
| Study group | Role | What they receive |
|---|---|---|
| Decision support intervention | Experimental | Decision aid and care plan meeting Receives: Behavioral: Goals of care decision support |
| Control | No intervention | Attention control information on dementia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Communication and Decision-making
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.
Measured: 3 months
Secondary outcomes (8)
Number of Palliative Care Domains in Care Plan
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.
Measured: 9 months
Satisfaction With Care
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.
Measured: 9 months
Comfort in Dying
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.
Measured: 9 months
Alzheimer Disease Related Quality of Life
The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.
Measured: 9 months
Quality of Dying
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.
Measured: 9 months
Frequency of Communication
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
Measured: 9 months
Hospice Referral
Number of participants with a referral to hospice services
Measured: 9 months
Hospitalizations
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Laura C Hanson, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565642
- Sponsor's protocol ID
- 10-0699
- Other IDs
- R01AG037483
- Acronym
- GOC
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2012
- Last updated
- 10 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 29957095Hanson 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.
PubMed 27893884Hanson 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.
PubMed 27271683
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
- ClinicalTrials.gov ID
- NCT01565642
- Acronym / sponsor ID
- GOC / 10-0699
- Conditions
- Dementia
- Keywords
- Dementia, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 10 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision support intervention | Experimental | Behavioral: Goals of care decision supportDecision aid and care plan meeting |
| Control | No intervention | –Attention control information on dementia care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia
Key exclusion criteria (1 listed)
- Non-related legal surrogate without personal knowledge of resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goals of care decision supportDecision aid and care plan meeting | Behavioural | Decision support intervention |
Primary outcome
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.
8 secondary outcomes
Number of Palliative Care Domains in Care Plan
Time frame: 9 months
Satisfaction With Care
Time frame: 9 months
Comfort in Dying
Time frame: 9 months
Alzheimer Disease Related Quality of Life
Time frame: 9 months
Quality of Dying
Time frame: 9 months
Frequency of Communication
Time frame: 9 months
Hospice Referral
Time frame: 9 months
Hospitalizations
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29957095Ernecoff 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.
- Derived from this study: PubMed 27893884Hanson 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.
- Derived from this study: PubMed 27271683Hanson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura C Hanson, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goals of care decision support in people with Dementia, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Communication and Decision-making (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565642, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.