Comparison of an Easy to Read Advance Directive Versus a Standard Advance Directive

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00328055
First received: May 18, 2006
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to compare the acceptability, usefulness, self-efficacy and comprehension of an easy-to-read advance directive form versus a standard advance directive form written at a post graduate reading level.


Condition Intervention
Aging
Behavioral: AD-Easy (Advance Directive-Easy)
Behavioral: AD-Standard (Advance Directive-Standard)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Official Title: Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Acceptability
  • self-efficacy
  • attitudes about the forms utility
  • comprehension
  • preference

Secondary Outcome Measures:
  • 6 month outcomes included whether participant talked with their doctor about treatment wishes, talked to family, thought about treatment decisions, or filled out an advance directive

Estimated Enrollment: 200
Study Start Date: August 2004
Estimated Study Completion Date: July 2005
Detailed Description:

Advance directives are forms that allow patients to document their medical treatment preferences and to designate another person to help make medical decisions if they were to become too sick to make their own decisions. Most patients, even seriously ill older adults, do not fill out advance directive forms. Since the mean reading level in the US is at the 8th grade level (5th grade for elders) and since most advance directive documents are written beyond a 12th grade reading level, many patients may not be able to read, much less complete, the standard advance directive forms.

This study hypothesized that an advance directive form written at a 5th grade reading level (AD-Easy) that included culturally appropriate graphics explaining the text, and also included questions concerning patients' values, would be preferred over the standard advance directive form being used in California (AD-Standard).

The participant's literacy level and baseline knowledge of advance directive topics were assessed. Participants were then stratified by literacy level to be randomized to first attempt to read and complete either the AD-Easy or the AD-Standard. Then the participant's acceptance of the forms, self-efficacy or confidence with treatment decisions, attitudes about the form's utility, and post form review comprehension were assessed. Participants then crossed over to review the alternate form and were asked to state which form they preferred to take home. Six months later participants were called and asked if they had thought about their medical treatment preferences, spoken to their family, friends, or doctor about their treatment preferences, or if they filled out the advance directive form.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 50 years
  • Primary physician in the General Medicine Clinic at San Francisco General Hospital, San Francisco, CA
  • English- or Spanish-speaking

Exclusion Criteria:

  • Blind
  • Deaf
  • Delirious
  • Demented
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328055

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Pfizer
Investigators
Principal Investigator: Rebecca Sudore, MD University of California, San Francisco
  More Information