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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328055
• Other study ID #: AG0066
• Secondary ID: 5T32AG000212-145
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: April 21, 2011
• Start date: August 2004
• Est. completion date: July 2005

Study information

• Verified date: April 2011
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• AD-Easy (Advance Directive-Easy)

• AD-Standard (Advance Directive-Standard)

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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.

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. — View Citation

Ott BB, Hardie TL. Readability of advance directive documents. Image J Nurs Sch. 1997 Spring;29(1):53-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability
Primary	self-efficacy
Primary	attitudes about the forms utility
Primary	comprehension
Primary	preference
Secondary	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