AgingNCT00328055
Comparison of an Easy to Read Advance Directive Versus a Standard Advance Directive
A study testing AD-Easy (Advance Directive-Easy) and AD-Standard (Advance Directive-Standard) in people with Aging, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- AD-Easy (Advance Directive-Easy) and AD-Standard (Advance Directive-Standard)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 50 years
- Primary physician in the General Medicine Clinic at San Francisco General Hospital, San Francisco, CA
- English- or Spanish-speaking
Who cannot join
- Blind
- Deaf
- Delirious
- Demented
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- AD-Easy (Advance Directive-Easy), AD-Standard (Advance Directive-Standard)
- Keywords
- functional ability, patient care management, communication, literacy
- Medical subject headings
- Communication, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-Easy (Advance Directive-Easy)Behavioural
AD-Standard (Advance Directive-Standard)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
self-efficacy
attitudes about the forms utility
comprehension
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startAug 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Pfizer
- Investigators
- Rebecca Sudore, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328055
- Sponsor's protocol ID
- AG0066
- Other IDs
- 5T32AG000212-14, 5K07AG000912-05, 5R01AG023626-02, 5K23RR016539-05
- Status last verified
- Apr 2011
- First submitted
- 18 May 2006
- Last updated
- 25 Apr 2011
- Results posted
- No
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.
PubMed 2000111Ott 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.
PubMed 9127541Nolan 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.
PubMed 12624865Jacobson 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.
PubMed 10517717Kirsch 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 at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive
- ClinicalTrials.gov ID
- NCT00328055
- Acronym / sponsor ID
- AG0066
- Conditions
- Aging
- Keywords
- functional ability, patient care management, communication, literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Pfizer
- Study start
- Aug 2004
- Study completion
- Jul 2005
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 50 years
- Primary physician in the General Medicine Clinic at San Francisco General Hospital, San Francisco, CA
- English- or Spanish-speaking
Key exclusion criteria (4 listed)
- Blind
- Deaf
- Delirious
- Demented
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-Easy (Advance Directive-Easy) | Behavioural | – |
| AD-Standard (Advance Directive-Standard) | Behavioural | – |
Primary outcome
Acceptability
self-efficacy
attitudes about the forms utility
comprehension
preference
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
- Background: PubMed 2000111Emanuel 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.
- Background: PubMed 9127541Ott 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.
- Background: PubMed 12624865Nolan 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.
- Background: PubMed 10517717Jacobson 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.
- BackgroundKirsch 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.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Sudore, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AD-Easy (Advance Directive-Easy) and AD-Standard (Advance Directive-Standard) in people with Aging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328055, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2011.