TY - JOUR
T1 - Protocol for the osteoporosis choice trial. A pilot randomized trial of a decision aid in primary care practice
AU - Pencille, Laurie J.
AU - Campbell, Megan E.
AU - Van Houten, Holly K.
AU - Shah, Nilay D.
AU - Mullan, Rebecca J.
AU - Swiglo, Brian A.
AU - Breslin, Maggie
AU - Kesman, Rebecca L.
AU - Tulledge-Scheitel, Sidna M.
AU - Jaeger, Thomas M.
AU - Johnson, Ruth E.
AU - Bartel, Gregory A.
AU - Wermers, Robert A.
AU - Melton, L. Joseph
AU - Montori, Victor M.
N1 - Funding Information:
All authors were salaried at the Mayo Clinic while contributing to this manuscript. The project outlined here is funded by the Mayo Clinic Foundation for Medical Education and Research. This funding source had role in the design of this study and will not have any role during its execution, analyses, and writing and decision to submit results. The Knowledge and Encounter Research Unit at Mayo Clinic houses the processes of design and evaluation of decision aids, such as Osteoporosis Choice, decides on topics of investigation, pursues funding, designs and conducts evaluation trials and reports their findings. Investigators with this unit including the authors of this manuscript do not receive funding from any for-profit pharmaceutical or device manufacturer. The unit makes successful decision aids available online free of charge at http://mayoresearch.mayo.edu/mayo/research/ker_unit/
PY - 2009/12/10
Y1 - 2009/12/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=73149097669&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=73149097669&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-10-113
DO - 10.1186/1745-6215-10-113
M3 - Article
C2 - 20003299
AN - SCOPUS:73149097669
SN - 1745-6215
VL - 10
JO - Trials
JF - Trials
M1 - 113
ER -