Pain ManagementNCT01352832
The Alabama NSAIDs Patient Safety Survey, Phase II: Reducing Disparities in Risk Awareness and Communication
A study testing Interactive DVD in people with Pain Management, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Interactive DVD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or older
- Chronic NSAIDs (prescribed or recommended by their doctor)
- Seen by a primary care physician
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Phase II of The Alabama NSAID Patient Safety Survey: Reducing Disparities in Risk Awareness and Communication
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:
Read more
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.
Read the 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.
- Conditions
- Pain Management
- Being tested
- Interactive DVD, Usual Care
- Keywords
- Chronic NSAID use
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive DVDOther
Also called DVD, Educational Materials, Narrative
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 CareOther
Also called Routine care, Standard Care
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Interactive DVD | Experimental | 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. Receives: Other: Interactive DVD |
| Usual Care | Placebo comparator | Patients randomized to this arm receive their usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician-Patient Communication
Patients will report that they had a conversation with their doctor about safe NSAID use
Measured: Three months from initial survey
Secondary outcomes (1)
Risk behavior related to NSAID use
Patients will report risky NSAID ingestion behaviors (e.g., concomitant use of OTC and prescription NSAIDs)
Measured: Three months post initial survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Weech-Maldonado, University of Alabama at Birmingham
- Investigators
- Robert Weech-Maldonado, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352832
- Sponsor's protocol ID
- X091029002
- Other IDs
- 1U18HS016956
- Status last verified
- Mar 2013
- First submitted
- 11 May 2011
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II of The Alabama NSAID Patient Safety Survey: Reducing Disparities in Risk Awareness and Communication
- ClinicalTrials.gov ID
- NCT01352832
- Acronym / sponsor ID
- X091029002
- Conditions
- Pain Management
- Keywords
- Chronic NSAID use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive DVD | Experimental | Other: Interactive DVDPatients 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 comparator | Other: Usual CarePatients randomized to this arm receive their usual care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years of age or older
- Chronic NSAIDs (prescribed or recommended by their doctor)
- Seen by a primary care physician
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive DVDAlso: DVD, Educational Materials, NarrativeAn 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 | Interactive DVD |
| Usual CareAlso: Routine care, Standard CareUsual Care | Other | Usual Care |
Primary outcome
Physician-Patient Communication
Time frame: Three months from initial survey
Patients will report that they had a conversation with their doctor about safe NSAID use
1 secondary outcome
Risk behavior related to NSAID use
Time frame: Three months post initial survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Weech-Maldonado, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive DVD in people with Pain Management, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-Patient Communication (time frame: Three months from initial survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2013.