Improving Osteoporosis Care in High-Risk Home Health Patients

NCT ID: NCT00679198

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 667 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-08-31

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.

Conditions

Patient Compliance; Communication; Osteoporosis; Fractures, Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

nurse-patient communication

Intervention Type: BEHAVIORAL

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.

2

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alacare Home Health and Hospice

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Meredith Kilgore, PhD, RN

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meredith L Kilgore, PhD RN

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Department of Rheumatology

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

X071029007

Identifier Type: -

Identifier Source: org_study_id