Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II

PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015.

Abstract

Purpose: Osteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown.

Methods: Patient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.

Results: We enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01), improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively), had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001). Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer). There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07); medication adherence at 6 months was no different across arms.

Conclusion: Supporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.

Trial registration: clinical trials.gov NCT00949611.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Decision Support Systems, Clinical
  • Decision Support Techniques
  • Diphosphonates / adverse effects
  • Diphosphonates / therapeutic use*
  • Female
  • Humans
  • Medication Adherence
  • Middle Aged
  • Osteoporosis / drug therapy*
  • Patient Education as Topic / methods*
  • Patient Participation / methods*

Substances

  • Diphosphonates

Associated data

  • ClinicalTrials.gov/NCT00949611

Grants and funding

This study was supported by a grant from the Foundation for Informed Medical Decision Making (Now the Informed Medical Decisions Foundation, http://www.informedmedicaldecisions.org/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.