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Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

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

Authors: Laurie J Pencille, Megan E Campbell, Holly K Van Houten, Nilay D Shah, Rebecca J Mullan, Brian A Swiglo, Maggie Breslin, Rebecca L Kesman, Sidna M Tulledge-Scheitel, Thomas M Jaeger, Ruth E Johnson, Gregory A Bartel, Robert A Wermers, L Joseph Melton III, Victor M Montori

Published in: Trials | Issue 1/2009

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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 (O STEOPOROSIS 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 O STEOPOROSIS 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
Appendix
Available only for authorised users
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Metadata
Title
Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice
Authors
Laurie J Pencille
Megan E Campbell
Holly K Van Houten
Nilay D Shah
Rebecca J Mullan
Brian A Swiglo
Maggie Breslin
Rebecca L Kesman
Sidna M Tulledge-Scheitel
Thomas M Jaeger
Ruth E Johnson
Gregory A Bartel
Robert A Wermers
L Joseph Melton III
Victor M Montori
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-113

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