Clinical trial NCT00679198: Improving Osteoporosis Care in High-Risk Home Health Patients
Official title: Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Communication
Osteoporosis
Fractures, Bone
Keywords: osteoporosis
fracture
communication
prescription medication
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Alacare Home Health and Hospice
First posted: 2008-05-16
Enrollment: 667
Sex: ALL
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Increased receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis
timeFrame: within 3 months of discharge from home health care
Secondary outcomes:
measure: Increased persistence in the use of these therapies
timeFrame: 18 months after their discharge from home health care
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Department of Rheumatology
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Meredith L Kilgore, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: