Improving Osteoporosis Care in High-Risk Home Health Patients
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Purpose
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 | Intervention |
|---|---|
|
Patient Compliance Communication Osteoporosis Fractures, Bone |
Behavioral: nurse-patient communication |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
| Official Title: | Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention |
- 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 ] [ Designated as safety issue: No ]
- Increased persistence in the use of these therapies [ Time Frame: 18 months after their discharge from home health care ] [ Designated as safety issue: No ]
| Enrollment: | 667 |
| Study Start Date: | March 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
Standard care
|
Eligibility| Ages Eligible for Study: | up to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Meredith Kilgore, PhD, RN, Associate Professor of Medicine, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00679198 History of Changes |
| Other Study ID Numbers: | X071029007 |
| Study First Received: | May 14, 2008 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
osteoporosis fracture communication prescription medication |
Additional relevant MeSH terms:
|
Fractures, Bone Osteoporosis Wounds and Injuries |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013