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

Pain Management Clinical Trial

Official title:

Phase II of The Alabama NSAID Patient Safety Survey: Reducing Disparities in Risk Awareness and Communication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352832
• Other study ID #: X091029002
• Secondary ID: 1U18HS016956
• Status: Completed
• Phase: N/A
• First received: May 11, 2011
• Last updated: March 8, 2013
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), expose patients to substantial risk of toxicity. Risks are compounded by the fact that patients may frequently take both Over-the-Counter (OTC) and prescription NSAIDs, a fact they often do not report to their physician. Further, our prior work suggests that African American patients may be at greater risk from NSAIDs than whites. While the consequences of unsafe NSAID use are well recognized, effective ways of improving safe use are as yet poorly established. Three findings from medical interaction research suggest that a solution may lie in improving doctor-patient communication. First, patients' communicative behaviors influence those of their doctors. Patients who actively participate by preparing beforehand for the visit, asking questions, and expressing concerns, get more information from their doctor, and in many cases receive more diagnostic and therapeutic action. Second, patients can indeed be easily taught to use active communication behaviors during medical encounters. Third, better communicators have better outcomes.A recent report of the Institute of Medicine (IOM) noted that medication-related injuries are frequent, costly and in many cases preventable and strongly recommended that measures be instituted to strengthen patients' capacities for sound medication self-management and communication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 19 years of age or older

• Chronic NSAIDs (prescribed or recommended by their doctor)

• Seen by a primary care physician

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain Management

Intervention

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.
• Usual Care
Usual Care

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician-Patient Communication	Patients will report that they had a conversation with their doctor about safe NSAID use	Three months from initial survey	No
Secondary	Risk behavior related to NSAID use	Patients will report risky NSAID ingestion behaviors (e.g., concomitant use of OTC and prescription NSAIDs)	Three months post initial survey	No