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The Alabama NSAIDs Patient Safety Survey, Phase II: Reducing Disparities in Risk Awareness and Communication

NCT01352832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2013-03-11

No results posted yet for this study

Summary

The investigators propose a two-year group randomized trial of physician practices to test the effectiveness of an interactive DVD that presents a culturally appropriate communication training program for patients called "How To Talk To Your Doctor (and Get Your Doctor to Talk to YOU!)" in promoting safe prescription and use of Nonsteroidal anti-inflammatory drugs (NSAIDs) in the outpatient setting (HTTTYD-NSAIDs).

The outcome of interest is safer use of NSAIDs as reported by patients. The aims are to:

Aim 1. Develop an interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs) that presents culturally appropriate "stories" through which a viewer can learn risk factors for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs with their doctor.

Aim 2. Conduct a group-randomized trial to test the following three hypotheses about the effectiveness of the interactive DVD in promoting safer use of NSAIDs:

Hypothesis 1: Intervention group patients will be more likely to report that they had a conversation with their doctor about safe NSAID use than control group patients.

Hypothesis 2: Intervention patients will report significantly fewer risky NSAID ingestion behaviors (e.g., concomitant use of OTC and prescription NSAIDs) than control patients.

Hypothesis 3: There will be no difference in the intervention's effectiveness between African American and White participants.

Conditions

  • Pain Management

Interventions

OTHER

Interactive DVD

An interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs) that presents culturally appropriate "stories" through which a viewer can learn risk factors for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs with their doctor.

OTHER

Usual Care

Usual Care

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Robert Weech-Maldonado, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-12-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352832 on ClinicalTrials.gov