Trial Outcomes & Findings for Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia (NCT NCT01565642)

NCT ID: NCT01565642

Last Updated: 2018-08-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 302 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-08-10

Participant Flow

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

Unit of analysis: nursing homes

Participant milestones

Measure	Decision Support Intervention Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control Attention control information on dementia care
Overall Study STARTED	151 11	151 11
Overall Study COMPLETED	149 11	150 11
Overall Study NOT COMPLETED	2 0	1 0

Reasons for withdrawal

Measure	Decision Support Intervention Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control Attention control information on dementia care
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Decision Support Intervention n=151 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=151 Participants Attention control information on dementia care	Total n=302 Participants Total of all reporting groups
Age, Continuous	85.7 years STANDARD_DEVIATION 7.6 • n=5 Participants	87.3 years STANDARD_DEVIATION 6.7 • n=7 Participants	86.5 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	125 Participants n=7 Participants	246 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	26 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	14 Participants n=5 Participants	25 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	134 Participants n=5 Participants	123 Participants n=7 Participants	257 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	151 Participants n=5 Participants	151 Participants n=7 Participants	302 Participants n=5 Participants
Dementia Stage: Global Deterioration Scale (GDS) GDS 5	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Dementia Stage: Global Deterioration Scale (GDS) GDS 6	79 Participants n=5 Participants	73 Participants n=7 Participants	152 Participants n=5 Participants
Dementia Stage: Global Deterioration Scale (GDS) GDS 7	34 Participants n=5 Participants	42 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Decision Support Intervention n=149 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=150 Participants Attention control information on dementia care
Quality of Communication and Decision-making QOC score	6.0 units on a scale Standard Deviation 2.0	5.6 units on a scale Standard Deviation 1.8
Quality of Communication and Decision-making QOC End of Life score	3.7 units on a scale Standard Deviation 2.7	3.0 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Decision Support Intervention n=149 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=150 Participants Attention control information on dementia care
Number of Palliative Care Domains in Care Plan	5.9 units on a scale Standard Deviation 2.2	5.3 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Decision Support Intervention n=149 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=150 Participants Attention control information on dementia care
Satisfaction With Care	31.0 units on a scale Standard Deviation 5.9	31.6 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 9 months

Population: Decedents only--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. Higher scores indicate better comfort.

Outcome measures

Measure	Decision Support Intervention n=27 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=33 Participants Attention control information on dementia care
Comfort in Dying	34.0 units on a scale Standard Deviation 5.7	32.7 units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 9 months

Population: 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).

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

Outcome measures

Measure	Decision Support Intervention n=122 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=117 Participants Attention control information on dementia care
Alzheimer Disease Related Quality of Life	67.8 units on a scale Standard Deviation 15.9	65.9 units on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: 9 months

Population: Decedents only--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. Higher scores indicate better quality of the dying experience.

Outcome measures

Measure	Decision Support Intervention n=27 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=33 Participants Attention control information on dementia care
Quality of Dying	41.7 units on a scale Standard Deviation 7.1	41.7 units on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Decision Support Intervention n=149 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=150 Participants Attention control information on dementia care
Frequency of Communication	121 Participants	123 Participants

SECONDARY outcome

Timeframe: 9 months

Number of participants with a referral to hospice services

Outcome measures

Measure	Decision Support Intervention n=149 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=150 Participants Attention control information on dementia care
Hospice Referral	17 Participants	18 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Decision Support Intervention n=149 Participants Decision aid and care plan meeting Goals of care decision support: Decision aid and care plan meeting	Control n=150 Participants Attention control information on dementia care
Hospitalizations	0.08 Hospital transfers per 90 person-days	0.16 Hospital transfers per 90 person-days

Adverse Events

Decision Support Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 27 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 33 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura C. Hanson, MD, MPH

University of North Carolina at Chapel Hill

Phone: 919-843-4096

Email: lhanson@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place