Trial Outcomes & Findings for Improving Decision Making About Feeding Options for Dementia (NCT NCT01113749)

NCT ID: NCT01113749

Last Updated: 2023-10-04

Results Overview

Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 256 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-10-04

Participant Flow

425 eligible dementia resident-surrogate dyads identified ; 118 surrogates refused, 41 unable to contact, and 10 unable to participate due to concurrent illness.

No enrolled participants were excluded before assignment

Participant milestones

Measure	Decision Support Structured decision aid with prompting to share information in discussion with primary treating health care providers.	Control
Overall Study STARTED	127	129
Overall Study COMPLETED	126	127
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Decision Support Structured decision aid with prompting to share information in discussion with primary treating health care providers.	Control
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Improving Decision Making About Feeding Options for Dementia

Baseline characteristics by cohort

Measure	Decision Support n=127 Participants Structured decision aid with prompting to share information in discussion with primary treating health care providers.	Control n=129 Participants	Total n=256 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	127 Participants n=5 Participants	129 Participants n=7 Participants	256 Participants n=5 Participants
Age, Continuous	85.2 years STANDARD_DEVIATION 2.1 • n=5 Participants	85.3 years STANDARD_DEVIATION 2.3 • n=7 Participants	85.2 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	98 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment United States	127 participants n=5 Participants	129 participants n=7 Participants	256 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: intention to treat

Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.

Outcome measures

Measure	Decision Support Intervention n=127 Participants Decision aid	Control n=129 Participants Usual care
Decisional Conflict Scale	1.65 units on a scale 95% Confidence Interval NA • Interval 1.53 to 1.73	1.97 units on a scale 95% Confidence Interval NA • Interval 1.86 to 2.14

SECONDARY outcome

Timeframe: 3 months

Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.

Outcome measures

Measure	Decision Support Intervention n=127 Participants Decision aid	Control n=129 Participants Usual care
Percent With Treatment Decisions	46 percentage of subjects	33 percentage of subjects

POST_HOC outcome

Timeframe: 9 months

Population: intention to treat

Percentage of subjects with weight loss at 9 months

Outcome measures

Measure	Decision Support Intervention n=127 Participants Decision aid	Control n=129 Participants Usual care
Percentage of Subjects With Weight Loss	6 percentage of participants	16 percentage of participants

Adverse Events

Decisions Support Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 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 Chapel Hill

Phone: 9199665945

Email: lhanson@med.unc.edu

Results disclosure agreements

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