Improving Osteoporosis Care in High-Risk Home Health Patients

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT00679198

Collaborator

Alacare Home Health and Hospice (Other)

667

Enrollment

Location

Arms

Duration (Months)

16.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Compliance Communication Osteoporosis Fractures, Bone	Behavioral: nurse-patient communication	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

667 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Increased persistence in the use of these therapies [18 months after their discharge from home health care]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 95 Years

Sexes Eligible for Study:

All

Accepts 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.