Improving Osteoporosis Care in High-Risk Home Health Patients

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679198
• Other study ID #: X071029007
• Status: Completed
• Phase: N/A
• First received: May 14, 2008
• Last updated: January 14, 2013
• Start date: March 2009
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Communication
• Fractures, Bone
• Osteoporosis
• Patient Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Department of Rheumatology	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Alacare Home Health and Hospice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Increased persistence in the use of these therapies		18 months after their discharge from home health care	No