Osteoporosis Clinical Trial
Official title:
Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention
SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to
improve osteoporosis care and test a novel intervention in a group-randomized trial of 27
home health offices and 1,000 patients referred to home health care with a history of
fracture.
Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training
to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and
fracture risk; (2) automated prompts within the home health agency's electronic medical
record system to promote appropriate osteoporosis management; and (3) implementation of
osteoporosis-related standardized care pathways and order sets.
Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to
promote initial use of osteoporosis medications and adherence to treatment after discharge
from home health. We hypothesize that:
H1: Patients in the intervention group will have increased initial receipt of osteoporosis
prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis
compared to patients receiving usual care; H2: Patients in the intervention group will
demonstrate increased persistence in the use of these therapies compared to those receiving
usual care.
Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and
mortality, patient-reported quality of life, and health services utilization and costs.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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