Improving Osteoporosis Care in High-Risk Home Health Patients
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|ClinicalTrials.gov Identifier: NCT00679198|
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : January 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Patient Compliance Communication Osteoporosis Fractures, Bone||Behavioral: nurse-patient communication||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||667 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2012|
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
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.
No Intervention: 2
- Increased receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis [ Time Frame: within 3 months of discharge from home health care ]
- Increased persistence in the use of these therapies [ Time Frame: 18 months after their discharge from home health care ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679198
|United States, Alabama|
|University of Alabama at Birmingham Department of Rheumatology|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Meredith L Kilgore, PhD RN||University of Alabama at Birmingham|