Clinical trial NCT00387998: Health Education in Improving the Understanding of Medical Information
Official title: Randomized Trial of a Primer to Help Patients Understand Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-10-13
Enrollment: 555
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: RATIONALE: Understanding the risk of disease and prevention and screening activities to lower disease risk may help individuals make informed medical decisions.

PURPOSE: This randomized clinical trial is studying how well health education materials help participants understand medical information.

Detailed description: OBJECTIVES:

* Compare medical data interpretation skills in participants of low or high socioeconomic status who receive a general education primer (entitled "Know Your Chances: Understanding Health Statistics") vs a health education booklet (entitled "The Pocket Guide to Good Heath for Adults").

OUTLINE: This is a randomized, controlled study. Participants are stratified according to socioeconomic status (low vs high). Participants are randomized to 1 of 2 intervention arms.

* Arm I (control): Participants receive a health education booklet entitled "The Pocket Guide to Good Health for Adults," published by the Agency for Health Care Research and Quality, which contains general information about disease risk and reducing risk by following recommended prevention or screening activities.
* Arm II (primer): Participants receive a general education primer entitled "Know your chances: Understanding health statistics," which teaches how to understand disease risk and the benefits and risks of intervention.

Within 2 weeks after receiving the education material, participants in both arms complete a survey, including a medical data interpretation test, STAT-interest, STAT-confidence, and user ratings of the education materials.

PROJECTED ACCRUAL: A total of 555 participants were accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * High socioeconomic status

    * Attended Dartmouth Community Medical School in the past
  * Low socioeconomic status

    * Veteran or family member enrolled in a Veteran Affairs clinic

PATIENT CHARACTERISTICS:

* English speaking
* No more than 1 participant per household

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Ability to interpret medical statistics as measured by a medical data interpretation test
timeFrame: 2 weeks
Secondary outcomes:
measure: Interest in interpreting medical statistics, as measured by STAT-interest
timeFrame: 2 weeks
measure: Confidence in interpreting medical statistics, measured by STAT-confidence
timeFrame: 2 weeks
measure: User ratings of materials
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Steven Woloshin, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: White River Junction Veterans Affairs Medical Center
name: Lisa Schwartz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woloshin S, Schwartz LM, Welch HG. The effectiveness of a primer to help people understand risk: two randomized trials in distinct populations. Ann Intern Med. 2007 Feb 20;146(4):256-65. doi: 10.7326/0003-4819-146-4-200702200-00004.