Improving Osteoporosis Care in High-Risk Home Health Patients

Study Overview
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Brief Summary
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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.

Official Title
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Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention

Conditions
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Patient Compliance, Communication, Osteoporosis, Fractures, Bone

Intervention / Treatment
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* Behavioral: nurse-patient communication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Behavioral: nurse-patient communication<br>* 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. Thus, we will provide a comprehensive, integrated approach to the management of osteoporosis among patients with a history of insufficiency fractures that is highly generalizable to a national setting.<br>|
| No Intervention: 2<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased persistence in the use of these therapies |  | 18 months after their discharge from home health care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, fracture, communication, prescription medication