Improving Decision Making About Feeding Options for Dementia

Dementia Clinical Trial

Official title:

Improving Decision Making About Feeding Options for Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113749
• Other study ID #: 05-3105
• Secondary ID: 5R01NR009826
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: June 2010

Study information

• Verified date: April 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Feeding Options in Dementia Decision Aid
Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Conflict Scale	Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.	3 months
Secondary	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.	3 months