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
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 April 14, 2014