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OpenTrials
Completed

NCT Number: NCT00328055

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

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.

Completed

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-Easy (Advance Directive-Easy)

Behavioral

AD-Standard (Advance Directive-Standard)

Behavioral

Primary outcomes

  1. Acceptability

  2. self-efficacy

  3. attitudes about the forms utility

  4. comprehension

  5. preference

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Collaborators

  • Pfizer

Registry information

Official study title

Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive

Important dates

Study start
2004
Study completion
2005
First posted
May 19, 2006
Registry last updated
Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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