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

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

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: AD-Easy (Advance Directive-Easy); Behavioral: AD-Standard (Advance Directive-Standard)

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
• Enrollment: 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Acceptability
self-efficacy
attitudes about the forms utility
comprehension
preference

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Collaborators: Pfizer
• Investigators: Principal Investigator: Rebecca Sudore, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Emanuel LL, Barry MJ, Stoeckle JD, Ettelson LM, Emanuel EJ. Advance directives for medical care--a case for greater use. N Engl J Med. 1991 Mar 28;324(13):889-95. doi: 10.1056/NEJM199103283241305.
• Ott BB, Hardie TL. Readability of advance directive documents. Image J Nurs Sch. 1997 Spring;29(1):53-7. doi: 10.1111/j.1547-5069.1997.tb01140.x.
• Nolan MT. Could lack of clarity in written advance directives contribute to their ineffectiveness? A study of the content of written advance directives. Appl Nurs Res. 2003 Feb;16(1):65-9. doi: 10.1053/apnr.2003.50007.
• Jacobson TA, Thomas DM, Morton FJ, Offutt G, Shevlin J, Ray S. Use of a low-literacy patient education tool to enhance pneumococcal vaccination rates. A randomized controlled trial. JAMA. 1999 Aug 18;282(7):646-50. doi: 10.1001/jama.282.7.646.
• Kirsch IS, Jungeblut A, Jenkins L, Kolstad A. Adult Literacy in America: A First Look at the Findings of the National Adult Literacy Survey. Washington, DC: Office of Educational Research and Improvement U.S. Department of Education; 1993 http://nces.ed.gov/pubs93/93275.pdf.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Study Completion: July 1, 2005

Study Registration Dates

• First Submitted: May 18, 2006
• First Submitted That Met QC Criteria: May 18, 2006
• First Posted (Estimate): May 19, 2006

Study Record Updates

• Last Update Posted (Estimate): April 25, 2011
• Last Update Submitted That Met QC Criteria: April 21, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: communication; patient care management; functional ability; literacy
• Other Study ID Numbers: AG0066; 5T32AG000212-14 (U.S. NIH Grant/Contract); 5K07AG000912-05 (U.S. NIH Grant/Contract); 5R01AG023626-02 (U.S. NIH Grant/Contract); 5K23RR016539-05 (U.S. NIH Grant/Contract)