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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Weech-Maldonado, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01352832
First received: May 11, 2011
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pain Management
Other: Interactive DVD
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase II of The Alabama NSAID Patient Safety Survey: Reducing Disparities in Risk Awareness and Communication

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Physician-Patient Communication [ Time Frame: Three months from initial survey ] [ Designated as safety issue: No ]
    Patients will report that they had a conversation with their doctor about safe NSAID use


Secondary Outcome Measures:
  • Risk behavior related to NSAID use [ Time Frame: Three months post initial survey ] [ Designated as safety issue: No ]
    Patients will report risky NSAID ingestion behaviors (e.g., concomitant use of OTC and prescription NSAIDs)


Enrollment: 422
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interactive DVD
Patients 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.
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 Names:
  • DVD
  • Educational Materials
  • Narrative
Placebo Comparator: Usual Care
Patients randomized to this arm receive their usual care.
Other: Usual Care
Usual Care
Other Names:
  • Routine care
  • Standard Care

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 years of age or older
  • Chronic NSAIDs (prescribed or recommended by their doctor)
  • Seen by a primary care physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352832

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Robert Weech-Maldonado, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Robert Weech-Maldonado, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01352832     History of Changes
Other Study ID Numbers: X091029002, 1U18HS016956
Study First Received: May 11, 2011
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Chronic NSAID use

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014