Clinical trial NCT00328055: Comparison of an Easy to Read Advance Directive Versus a Standard Advance Directive
Official title: Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: functional ability
patient care management
communication
literacy
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: Pfizer
First posted: 2006-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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 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

Primary outcomes:
measure: Acceptability
measure: self-efficacy
measure: attitudes about the forms utility
measure: comprehension
measure: preference
Secondary outcomes:
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
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rebecca Sudore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1001/jama.282.7.646.
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.