Study protocol

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Laurie J Pencille¹ , Megan E Campbell^1,2 , Holly K Van Houten^1,2 , Nilay D Shah^1,3 , Rebecca J Mullan¹ , Brian A Swiglo⁴ , Maggie Breslin^1,5 , Rebecca L Kesman⁶ , Sidna M Tulledge-Scheitel⁶ , Thomas M Jaeger⁶ , Ruth E Johnson⁷ , Gregory A Bartel⁸ , Robert A Wermers⁹ , L Joseph Melton III^9,10 and Victor M Montori^1,3,9

¹  Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA

²  Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

³  Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

⁴  Endocrinology, United Medical Specialties, Allina Medical Clinic, St. Paul, MN, USA

⁵  SPARC Design Studio, Center for Innovation, Mayo Clinic, Rochester, MN, USA

⁶  Division of Primary Care Internal Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA

⁷  Division of Preventive, Occupational, and Aerospace Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA

⁸  Department of Family Medicine, Mayo Clinic, Rochester, MN, USA

⁹  Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA

¹⁰  Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

author email corresponding author email

Trials 2009, 10:113doi:10.1186/1745-6215-10-113

Published:	10 December 2009

Abstract

Background

Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.

Methods/Design

This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months.

Discussion

This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid.

Trial registration

Clinical Trials.gov Identifier: NCT00578981