Improving Decision Making About Feeding Options for Dementia

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Feeding Options in Dementia Decision Aid

• Registration Number: NCT01113749
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-30
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-04
• Results First Submitted: 2012-04-17
• Results First Submitted QC: 2012-07-03
• Results First Posted: 2012-08-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• dementia diagnosis
• advanced cognitive impairment
• feeding problem
• age >= 65
• surrogate decision maker

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Exclusion Criteria

• feeding tube decision made
• hospice
• BMI > 26
• major psychosis or developmental delay

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision support	Feeding Options in Dementia Decision Aid	Structured decision aid with prompting to share information in discussion with primary treating health care providers.

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale	3 months	Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.

Secondary Outcome Measures

Name	Time	Method
Percent With Treatment Decisions	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.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States