The Alabama NSAIDs Patient Safety Survey, Phase II: Reducing Disparities in Risk Awareness and Communication
Phase II of The Alabama NSAID Patient Safety Survey: Reducing Disparities in Risk Awareness and Communication
2 other identifiers
interventional
422
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2011
CompletedFirst Posted
Study publicly available on registry
May 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 11, 2013
March 1, 2013
7 months
May 11, 2011
March 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physician-Patient Communication
Patients will report that they had a conversation with their doctor about safe NSAID use
Three months from initial survey
Secondary Outcomes (1)
Risk behavior related to NSAID use
Three months post initial survey
Study Arms (2)
Interactive DVD
EXPERIMENTALPatients randomized to this arm will receive a DVD 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.
Usual Care
PLACEBO COMPARATORPatients randomized to this arm receive their usual care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- Chronic NSAIDs (prescribed or recommended by their doctor)
- Seen by a primary care physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Weech-Maldonado, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2011
First Posted
May 12, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
March 11, 2013
Record last verified: 2013-03