Improving Osteoporosis Care in High-Risk Home Health Patients

This study has been completed.
Sponsor:
Collaborator:
Alacare Home Health and Hospice
Information provided by (Responsible Party):
Meredith Kilgore, PhD, RN, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00679198
First received: May 14, 2008
Last updated: January 14, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00679198

Locations
United States, Alabama
University of Alabama at Birmingham Department of Rheumatology
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Alacare Home Health and Hospice
Investigators
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:
Osteoporosis
Fractures, Bone
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014