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Randomized Controlled Trial
. 2014 Oct;20(5):638-48.
doi: 10.1111/jep.12193. Epub 2014 Jun 11.

A group-randomized trial of shared decision making for non-steroidal anti-inflammatory drug risk awareness: primary results and lessons learned

Michael J Miller  1 , Jeroan J Allison, Daniel J Cobaugh, Midge N Ray, Kenneth G Saag
Affiliations
Randomized Controlled Trial

A group-randomized trial of shared decision making for non-steroidal anti-inflammatory drug risk awareness: primary results and lessons learned

Michael J Miller et al. J Eval Clin Pract. 2014 Oct.

Abstract

Rationale, aims and objectives: Frequent use and serious adverse effects related to non-steroidal anti-inflammatory drugs (NSAIDs) underscore the need to raise patient awareness about potential risks. Partial success of patient- or provider-based interventions has recently led to interest in combined approaches focusing on both patient and physician. This research tested a shared decision-making intervention for increasing patient-reported awareness of NSAID risk.

Methods: A group randomized trial was performed in Alabama from 2005 to 2007. Intervention group doctor practices received continuing medical education (CME) about NSAIDs and patient activation tools promoting risk assessment and communication during visits. Comparison group doctor practices received only CME. Cross-sectional data were collected before and after the intervention. Generalized linear latent and mixed models with logistic link tested relationships among the intervention, study phase, intervention by study phase interaction and patient-reported awareness of risks with either prescription or over-the-counter (OTC) NSAIDs.

Results: Three hundred and forty-seven patients at baseline and 355 patients at follow-up participated in this study. The intervention [adjusted odds ratio (AOR)=0.74, P=0.248], follow-up study phase (AOR=1.31, P=0.300) and intervention by study phase interaction (AOR=0.98, P=0.942) were not significantly associated with patient-reported awareness of any prescription NSAID risk. Follow-up study phase was associated with increased odds of reporting any OTC NSAID risk awareness (AOR=2.99, P<0.001), but the patient activation intervention and intervention by study phase interaction were not significantly associated with patient-reported awareness of any OTC NSAID risk (AOR=0.98, P=0.929; AOR=0.87, P=0.693, respectively).

Conclusions: Our point-of-care intervention encouraging shared decision making did not increase NSAID risk awareness.

Keywords: NSAIDs; decision making; non-steroidal anti-inflammatory agents; patient safety; shared.

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Conflict of interest statement

Competing Interests

The authors declare that they have no competing interests.

Figures

Appendix 1.
Appendix 1.
Patient Intervention Checklist
Appendix 2.
Appendix 2.
Patient Screening survey
Figure Legend 1a.
Figure Legend 1a.
Consort Diagram - Baseline
Figure Legend 1b.
Figure Legend 1b.
Consort Diagram – Follow-up
Figure Legend 2.
Figure Legend 2.
Proportion of Patients Reporting Awareness of Any Prescription NSAID Risk Overall and by Study Group at Baseline and Follow-up
Figure Legend 3.
Figure Legend 3.
Proportion of Patients Reporting Awareness of Any Over-the-Counter NSAID Risk Overall and by Study Group at Baseline and Follow-up
See this image and copyright information in PMC

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