Back to resultsImproving Decision Making About Feeding Options for Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feeding Options in Dementia Decision Aid
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, Nutrition, Feeding
Eligibility Criteria
Inclusion Criteria:
- dementia diagnosis
- advanced cognitive impairment
- feeding problem
- age >= 65
- surrogate decision maker
Exclusion Criteria:
- feeding tube decision made
- hospice
- BMI > 26
- major psychosis or developmental delay
Sites / Locations
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Decision support
Control
Arm Description
Structured decision aid with prompting to share information in discussion with primary treating health care providers.
Usual care
Outcomes
Primary Outcome Measures
Decisional Conflict Scale
Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.
Secondary Outcome Measures
Percent With Treatment Decisions
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.
Full Information
NCT ID
NCT01113749
First Posted
April 15, 2010
Last Updated
October 2, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01113749
Brief Title
Improving Decision Making About Feeding Options for Dementia
Official Title
Improving Decision Making About Feeding Options for Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.
Detailed Description
This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Nutrition, Feeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision support
Arm Type
Experimental
Arm Description
Structured decision aid with prompting to share information in discussion with primary treating health care providers.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Feeding Options in Dementia Decision Aid
Intervention Description
Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.
Primary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percent With Treatment Decisions
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dementia diagnosis
advanced cognitive impairment
feeding problem
age >= 65
surrogate decision maker
Exclusion Criteria:
feeding tube decision made
hospice
BMI > 26
major psychosis or developmental delay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura C Hanson, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24083403
Citation
Hanson LC, Ersek M, Lin FC, Carey TS. Outcomes of feeding problems in advanced dementia in a nursing home population. J Am Geriatr Soc. 2013 Oct;61(10):1692-7. doi: 10.1111/jgs.12448. Epub 2013 Sep 19.
Results Reference
derived
PubMed Identifier
22091750
Citation
Hanson LC, Carey TS, Caprio AJ, Lee TJ, Ersek M, Garrett J, Jackman A, Gilliam R, Wessell K, Mitchell SL. Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2009-16. doi: 10.1111/j.1532-5415.2011.03629.x. Epub 2011 Sep 15.
Results Reference
derived
PubMed Identifier
20729251
Citation
Hanson LC, Gilliam R, Lee TJ. Successful clinical trial research in nursing homes: the Improving Decision-Making Study. Clin Trials. 2010 Dec;7(6):735-43. doi: 10.1177/1740774510380241. Epub 2010 Aug 20.
Results Reference
derived
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Improving Decision Making About Feeding Options for Dementia
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