Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

This study has been completed.
Sponsor:
Collaborator:
Attorney General Prescriber and Consumer Education Grant Program
Information provided by:
White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT00950014
First received: July 30, 2009
Last updated: April 8, 2010
Last verified: July 2009
  Purpose

The purpose of this study is to test comprehension of five numeric formats used to present data about treatment benefits and harms.


Condition Intervention
Risk Communication
Other: Presentation of drug efficacy and side effect data

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:
  • Comprehension questions (e.g., overall direction of effect and specific numeric data) [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk perceptions (e.g., how big or small is the benefit)and preferences (e.g., did the box help subjects understand the benefits) assessed via Internet surveys. [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Enrollment: 2944
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Percentage format only
Numbers are presented in percentage format (e.g., 35%, 0.2%) only.
Other: Presentation of drug efficacy and side effect data
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.
Experimental: Fixed frequency format only
Numbers are presented in fixed frequency format only (5 out of 1000, 0.6 out of 1000). Denominators remains the same for each number.
Other: Presentation of drug efficacy and side effect data
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.
Experimental: Variable frequency format
Frequency denominators are adjusted to keep the numerator greater than 1, so they may change throughout the survey (e.g., 6 out of 1000, 42 out of 100)
Other: Presentation of drug efficacy and side effect data
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.
Active Comparator: Fixed combination format
Numbers are presented with both percentages and frequencies, and frequency denominators remain fixed (e.g., _ out of 1000).
Other: Presentation of drug efficacy and side effect data
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.
Experimental: Variable combination format
Numbers are presented with both percentages and frequencies, but frequency denominators may vary (e.g., _ out of 1000, _ out of 100).
Other: Presentation of drug efficacy and side effect data
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950014

Sponsors and Collaborators
White River Junction VAMC
Attorney General Prescriber and Consumer Education Grant Program
Investigators
Principal Investigator: Lisa M Schwartz, MD, MS White River Junction VAMC
Principal Investigator: Steven Woloshin, MD, MS White River Junction VAMC
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa M. Schwartz, MD, MS, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT00950014     History of Changes
Other Study ID Numbers: 16783
Study First Received: July 30, 2009
Last Updated: April 8, 2010
Health Authority: United States: Federal Government

Keywords provided by White River Junction VAMC:
Numeracy

ClinicalTrials.gov processed this record on October 23, 2014