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Improving Osteoporosis Care in High-Risk Home Health Patients

Primary Purpose

Patient Compliance, Communication, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nurse-patient communication
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patient Compliance focused on measuring osteoporosis, fracture, communication, prescription medication

Eligibility Criteria

undefined - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham Department of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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

Standard care

Outcomes

Primary Outcome Measures

Increased receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis

Secondary Outcome Measures

Increased persistence in the use of these therapies

Full Information

First Posted
May 14, 2008
Last Updated
January 14, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Alacare Home Health and Hospice
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1. Study Identification

Unique Protocol Identification Number
NCT00679198
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Alacare Home Health and Hospice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance, Communication, Osteoporosis, Fractures, Bone
Keywords
osteoporosis, fracture, communication, prescription medication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
nurse-patient communication
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Increased persistence in the use of these therapies
Time Frame
18 months after their discharge from home health care

10. Eligibility

Sex
All
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith L Kilgore, PhD RN
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Department of Rheumatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Improving Osteoporosis Care in High-Risk Home Health Patients

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