NCT00950014

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,944

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 9, 2010

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

July 30, 2009

Last Update Submit

April 8, 2010

Conditions

Risk Communication

Keywords

Numeracy

Outcome Measures

Primary Outcomes (1)

  • Comprehension questions (e.g., overall direction of effect and specific numeric data)

    0 weeks (assessed during intervention)

Secondary Outcomes (1)

  • 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.

    0 weeks (assessed during intervention)

Study Arms (5)

Percentage format only

EXPERIMENTAL

Numbers are presented in percentage format (e.g., 35%, 0.2%) only.

Other: Presentation of drug efficacy and side effect data

Fixed frequency format only

EXPERIMENTAL

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

Variable frequency format

EXPERIMENTAL

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

Fixed combination format

ACTIVE COMPARATOR

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

Variable combination format

EXPERIMENTAL

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

Interventions

Presentation of drug efficacy and side effect dataOTHER

Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.

Fixed combination formatFixed frequency format onlyPercentage format onlyVariable combination formatVariable frequency format

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009 Apr 21;150(8):516-27. doi: 10.7326/0003-4819-150-8-200904210-00106. Epub 2009 Feb 16.

    PMID: 19221371BACKGROUND

  • Schwartz LM, Woloshin S, Welch HG. The drug facts box: providing consumers with simple tabular data on drug benefit and harm. Med Decis Making. 2007 Sep-Oct;27(5):655-62. doi: 10.1177/0272989X07306786. Epub 2007 Sep 14.

    PMID: 17873258BACKGROUND

  • Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med. 2011 Jul 19;155(2):87-96. doi: 10.7326/0003-4819-155-2-201107190-00004.

    PMID: 21768582DERIVED

Study Officials

  • Lisa M Schwartz, MD, MS

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Steven Woloshin, MD, MS

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 9, 2010

Record last verified: 2009-07