Improving Osteoporosis Care in High-Risk Home Health Patients

Not Applicable

Completed

• Conditions: Patient Compliance; Communication; Osteoporosis; Fractures, Bone
• Interventions: Behavioral: nurse-patient communication

• Registration Number: NCT00679198
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-16
• Study Start: 2009-03
• Primary Completion: 2011-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

Inclusion Criteria

• Patients will be identified as "at-risk" if they are referred to home health care for post-fracture care or if they are admitted for another reason and have a previous diagnosis of fracture.

Exclusion Criteria

• Patients in hospice, with a life expectancy < 1 year, over 95 years old, or with concomitant metabolic bone diseases (e.g. Paget's disease of bone) will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	nurse-patient communication	We will train home health nurses to act as patient advocates by communicating the risks and benefits of osteoporosis treatment to patients and their healthcare providers

Primary Outcome Measures

Name	Time	Method
Increased receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis	within 3 months of discharge from home health care

Secondary Outcome Measures

Name	Time	Method
Increased persistence in the use of these therapies	18 months after their discharge from home health care

Trial Locations

Locations (1)

University of Alabama at Birmingham Department of Rheumatology; 🇺🇸 Birmingham, Alabama, United States