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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328055
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : April 25, 2011
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
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 or disease Intervention/treatment Phase
Aging Behavioral: AD-Easy (Advance Directive-Easy) Behavioral: AD-Standard (Advance Directive-Standard) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Official Title: Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive
Study Start Date : August 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Acceptability
  2. self-efficacy
  3. attitudes about the forms utility
  4. comprehension
  5. preference

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328055

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Rebecca Sudore, MD University of California, San Francisco