Evaluating Ways to Improve Medication Use Among People With Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00567294
First received: November 30, 2007
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Behavioral: Mailed education
Behavioral: Telephone coaching program for patients
Behavioral: Medication adherence alert program for doctors
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication persistence [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

Enrollment: 2087
Study Start Date: November 2007
Study Completion Date: January 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Participants will receive mailed education materials on osteoporosis and medication use.
Behavioral: Mailed education
Mailed education materials on osteoporosis and medication use over a 1-year period
Experimental: B
Participants will receive a telephone coaching program.
Behavioral: Telephone coaching program for patients
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.
Experimental: C
Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.
Behavioral: Telephone coaching program for patients
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.
Behavioral: Medication adherence alert program for doctors
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567294

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Daniel H. Solomon, MD, MPH Brigham and Women's Hospital
Study Director: Timothy Gleeson, BS Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel H. Solomon, M.D.,MPH, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00567294     History of Changes
Other Study ID Numbers: P60 AR047782, P60AR047782, P60 AR047782-06A1
Study First Received: November 30, 2007
Last Updated: May 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Osteoporosis
Medication adherence
Telephonic education
Motivational interviewing

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014