Multifaceted interventions targeting high-risk patients and their primary care providers may improve the management of osteoporosis , but improvements are often clinical ly modest
This study aims to evaluate the effectiveness of primary care interventions to improve the detection and treatment of osteoporosis .
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 r and omization ( vs. cluster r and omization ) in pilot trials of decision aid efficacy . Methods / Design This is a protocol for a parallel , 2-arm , r and omized 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 practice s 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 r and omization , 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 :
Multifaceted interventions targeting high-risk patients and their primary care providers may improve the management of osteoporosis , but improvements are often clinical ly modest
This study aims to evaluate the effectiveness of primary care interventions to improve the detection and treatment of osteoporosis .