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Evaluating Ways to Improve Medication Use Among People With Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mailed education
Telephone coaching program for patients
Medication adherence alert program for doctors
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Medication adherence, Telephonic education, Motivational interviewing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE) program at the Pennsylvania Department of Aging who begin taking a medication for osteoporosis

Exclusion Criteria:

  • Unable to communicate over the telephone with health educators

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Participants will receive mailed education materials on osteoporosis and medication use.

Participants will receive a telephone coaching program.

Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.

Outcomes

Primary Outcome Measures

Medication adherence

Secondary Outcome Measures

Medication persistence

Full Information

First Posted
November 30, 2007
Last Updated
May 14, 2012
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00567294
Brief Title
Evaluating Ways to Improve Medication Use Among People With Osteoporosis
Official Title
Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Osteoporosis is a common bone disease in older adults in which the bones become weaker and prone to fracture. Medications are available to slow or even stop disease progression. However, very few adults who are prescribed osteoporosis medications actually follow through with filling their prescriptions and taking the medications. Ways to improve medication use have not been well developed or adequately tested. The purpose of this study is to evaluate a telephone coaching program, with or without helpful adherence notifications to doctors, in improving treatment adherence in older adults who are starting an osteoporosis medication.
Detailed Description
Fractures associated with osteoporosis are expected to rise to 3 million by 2025 with a cost of $25 billion in medical costs. Many of these fractures could be avoided through preventive measures, such as improved implementation of fall reduction strategies and use of effective medications. While medications can significantly reduce the chance of fractures among adults with osteoporosis, alarmingly few at-risk adults use osteoporosis treatments regularly. Only 10% to 30% of at-risk adults ever initiate osteoporosis medications, and of those, only 40% to 50% continue to fill their prescriptions after 1 year. There is a clear need to develop ways for improving adherence with osteoporosis medication regimens. The purpose of this study is to evaluate a telephone coaching program, with or without helpful adherence notifications to doctors, in improving treatment adherence in older adults who are starting an osteoporosis medication. Participation in this study will last 1 year. Through random assignment of doctor practices, participants will fall into one of three groups. Group A participants will receive mailed education materials on osteoporosis and medication use throughout the 1-year study. Group B participants will receive monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule. Participants will also receive specially tailored education on osteoporosis and fracture prevention during the phone calls. A close family member or friend of the participant will be contacted via phone two times during the study year. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely. Group C participants will receive the same treatment as Group B. Doctors assigned to Group C will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among patients. Doctors will also receive alerts about any of their participating patients who are not filling medication prescriptions. The alert message will be provided in both paper and electronic format. The electronic format can be easily formatted, allowing the doctor to send a personalized letter to their patients. At the end of the study, all participants will complete a mailed questionnaire on their behaviors and demographics. Doctors will complete a mailed questionnaire aimed at determining what parts of the interventions were well received. The occurrence of hip, forearm, and/or upper arm fractures will be evaluated using Medicare claims data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Medication adherence, Telephonic education, Motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2087 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Participants will receive mailed education materials on osteoporosis and medication use.
Arm Title
B
Arm Type
Experimental
Arm Description
Participants will receive a telephone coaching program.
Arm Title
C
Arm Type
Experimental
Arm Description
Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.
Intervention Type
Behavioral
Intervention Name(s)
Mailed education
Intervention Description
Mailed education materials on osteoporosis and medication use over a 1-year period
Intervention Type
Behavioral
Intervention Name(s)
Telephone coaching program for patients
Intervention Description
A telephone coaching program that will involve twelve monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.
Intervention Type
Behavioral
Intervention Name(s)
Medication adherence alert program for doctors
Intervention Description
Doctors of participants will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among people with osteoporosis. Doctors will also receive alerts on any patients who are not filling their medication prescriptions.
Primary Outcome Measure Information:
Title
Medication adherence
Time Frame
At Month 12
Secondary Outcome Measure Information:
Title
Medication persistence
Time Frame
At Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE) program at the Pennsylvania Department of Aging who begin taking a medication for osteoporosis Exclusion Criteria: Unable to communicate over the telephone with health educators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel H. Solomon, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Gleeson, BS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22371876
Citation
Solomon DH, Iversen MD, Avorn J, Gleeson T, Brookhart MA, Patrick AR, Rekedal L, Shrank WH, Lii J, Losina E, Katz JN. Osteoporosis telephonic intervention to improve medication regimen adherence: a large, pragmatic, randomized controlled trial. Arch Intern Med. 2012 Mar 26;172(6):477-83. doi: 10.1001/archinternmed.2011.1977. Epub 2012 Feb 27.
Results Reference
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Evaluating Ways to Improve Medication Use Among People With Osteoporosis

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