Improving Osteoporosis Care in High-Risk Home Health Patients

NCT00679198 | Completed

• 1 other identifier: X071029007
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

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

Keywords

osteoporosis; fracture; communication; prescription medication

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Increased persistence in the use of these therapies

  18 months after their discharge from home health care

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

Standard care

Interventions

nurse-patient communication 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.

1

Eligibility Criteria

• Age: Up to 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Alacare Home Health and Hospice: collaborator

Study Sites (1)

University of Alabama at Birmingham Department of Rheumatology

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Patient Compliance; Communication; Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Meredith L Kilgore, PhD RN

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: March 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)