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


CONCLUSIONS
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.


BACKGROUND
Clinical Trials.gov Identifier: NCT00578981.
Pencille
Laurie J
LJ
Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA. pencille.laurie@mayo.edu
Campbell
Megan E
ME
Van Houten
Holly K
HK
Shah
Nilay D
ND
Mullan
Rebecca J
RJ
Swiglo
Brian A
BA
Breslin
Maggie
M
Kesman
Rebecca L
RL
Tulledge-Scheitel
Sidna M
SM
Jaeger
Thomas M
TM
Johnson
Ruth E
RE
Bartel
Gregory A
GA
Wermers
Robert A
RA
Melton
L Joseph
LJ
Montori
Victor M
VM
D003657:Decision Making; D004164:Diphosphonates / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D050723:Fractures, Bone / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000453:epidemiology; D010865:Pilot Projects; D011320:Primary Health Care / Q000379:methods*; D012307:Risk Factors
D004164:Diphosphonates