Improving Decision Making About Feeding Options for Dementia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01113749
First received: April 15, 2010
Last updated: July 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Dementia
Other: Feeding Options in Dementia Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Improving Decision Making About Feeding Options for Dementia

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Decisional Conflict Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 256
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision support
Structured decision aid with prompting to share information in discussion with primary treating health care providers.
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.
Other Name: Feeding Options in Dementia Decision Aid
No Intervention: Control
Usual care

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113749

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Laura C Hanson, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01113749     History of Changes
Other Study ID Numbers: 05-3105, 5R01NR009826
Study First Received: April 15, 2010
Results First Received: April 17, 2012
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Dementia
Nutrition
Feeding

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014