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

• Study Type: Interventional
• 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
• Enrollment: 302

Participant Flow

Recruitment Details	April 2012 to September 2014 enrolled dyads of persons with advanced dementia and family decision-makers from 22 participating nursing home sites.
Pre-assignment Details

Arm/Group Title	Decision Support Intervention		Control
Arm/Group Description	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting		Attention control information on dementia care
Period Title: Overall Study
	Number of participants	Number of units (nursing homes)	Number of participants	Number of units (nursing homes)
Started	151	11	151	11
Completed	149	11	150	11
Not Completed	2	0	1	0
Reason Not Completed
Withdrawal by Subject	2		1

Baseline Characteristics

Arm/Group Title		Decision Support Intervention	Control	Total
Arm/Group Description		Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care	Total of all reporting groups
Overall Number of Baseline Participants		151	151	302
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	151 participants	151 participants	302 participants
		85.7 (7.6)	87.3 (6.7)	86.5 (6.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	151 participants	151 participants	302 participants
	Female	121 80.1%	125 82.8%	246 81.5%
	Male	30 19.9%	26 17.2%	56 18.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	151 participants	151 participants	302 participants
	African American	14 9.3%	25 16.6%	39 12.9%
	White	134 88.7%	123 81.5%	257 85.1%
	Other	3 2.0%	3 2.0%	6 2.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	151 participants	151 participants	302 participants
		151 100.0%	151 100.0%	302 100.0%
Dementia Stage: Global Deterioration Scale (GDS) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	151 participants	151 participants	302 participants
	GDS 5	38 25.2%	36 23.8%	74 24.5%
	GDS 6	79 52.3%	73 48.3%	152 50.3%
	GDS 7	34 22.5%	42 27.8%	76 25.2%
		[1] Measure Description: The Global deterioration scale includes seven different diagnostic stages ranging between "no cognitive deterioration" and "very serious cognitive deterioration." It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline) with higher scores reflecting greater severity of cognitive deterioration.

Outcome Measures

1. Primary Outcome

Title	Quality of Communication and Decision-making
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	149	150
Mean (Standard Deviation); Unit of Measure: units on a scale
QOC score	6.0 (2.0)	5.6 (1.8)
QOC End of Life score	3.7 (2.7)	3.0 (2.6)

2. Secondary Outcome

Title	Number of Palliative Care Domains in Care Plan
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	149	150
Mean (Standard Deviation); Unit of Measure: units on a scale
	5.9 (2.2)	5.3 (1.9)

3. Secondary Outcome

Title	Satisfaction With Care
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	149	150
Mean (Standard Deviation); Unit of Measure: units on a scale
	31.0 (5.9)	31.6 (5.3)

4. Secondary Outcome

Title	Comfort in Dying
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Decedents only--this outcome measure applies only to residents who die during Follow-Up.

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	27	33
Mean (Standard Deviation); Unit of Measure: units on a scale
	34.0 (5.7)	32.7 (5.4)

5. Secondary Outcome

Title	Alzheimer Disease Related Quality of Life
Description	The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

This measure applies only to those persons with dementia who remained alive through the 9 month follow-up. In addition there were 3 withdrawals from the study by 9 months. Thus the overall number of participants for this outcome measure are n=239 (n=302 after removal of 60 decedents and 3 withdrawn participants).

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	122	117
Mean (Standard Deviation); Unit of Measure: units on a scale
	67.8 (15.9)	65.9 (16.8)

6. Secondary Outcome

Title	Quality of Dying
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Decedents only--this measure applies only to residents who die during Follow-Up.

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	27	33
Mean (Standard Deviation); Unit of Measure: units on a scale
	41.7 (7.1)	41.7 (7.1)

7. Secondary Outcome

Title	Frequency of Communication
Description	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
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	149	150
Measure Type: Count of Participants; Unit of Measure: Participants
	121 81.2%	123 82.0%

8. Secondary Outcome

Title	Hospice Referral
Description	Number of participants with a referral to hospice services
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	149	150
Measure Type: Count of Participants; Unit of Measure: Participants
	17 11.4%	18 12.0%

9. Secondary Outcome

Title	Hospitalizations
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description:	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
Overall Number of Participants Analyzed	149	150
Measure Type: Number; Unit of Measure: Hospital transfers per 90 person-days
	0.08	0.16

Adverse Events

Time Frame	9 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Decision Support Intervention	Control
Arm/Group Description	Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Attention control information on dementia care
All-Cause Mortality
	Decision Support Intervention	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	27/151 (17.88%)	33/151 (21.85%)
Serious Adverse Events
	Decision Support Intervention	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/151 (0.00%)	0/151 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Decision Support Intervention	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/151 (0.00%)	0/151 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Laura C. Hanson, MD, MPH
• Organization: University of North Carolina at Chapel Hill
• Phone: 919-843-4096
• EMail: lhanson@med.unc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01565642
• Other Study ID Numbers: 10-0699; R01AG037483 ( U.S. NIH Grant/Contract )
• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Results First Submitted: May 25, 2018
• Results First Posted: August 10, 2018
• Last Update Posted: August 10, 2018