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

Michael J Miller; Jeroan J Allison; Daniel J Cobaugh; Midge N Ray; Kenneth G Saag

doi:10.1111/jep.12193

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

J Eval Clin Pract. 2014 Oct;20(5):638-48. doi: 10.1111/jep.12193. Epub 2014 Jun 11.

Authors

Michael J Miller¹, Jeroan J Allison, Daniel J Cobaugh, Midge N Ray, Kenneth G Saag

Affiliation

¹ Department of Pharmacy, Clinical and Administrative Sciences, College of Pharmacy, The University of Oklahoma Health Sciences Center, Tulsa, Oklahoma, USA.

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.

Publication types

Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Adverse Drug Reaction Reporting Systems*
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Awareness*
Cross-Sectional Studies
Female
Humans
Male
Patient Education as Topic*
Patient Participation / methods*
Risk Assessment
Risk Factors

Substances

Anti-Inflammatory Agents, Non-Steroidal

Abstract

Publication types

MeSH terms

Substances

Grants and funding