A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care

NCT01907269 | Completed Results DMC

• 2 other identifiers: X110928001R01AR060240
• Study Type: interventional
• Target: 2,684
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms. We hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Initiate an Osteoporosis Prescription Medication

  We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.

  6 months post-intervention

Secondary Outcomes (3)

• Number of Participants Who Reported Use of Calcium and Vitamin D

  6 and 18 months post-intervention

• Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing

  6 and 18 months post-intervention

• Number of Participants That Initiate an Osteoporosis Prescription Medication

  18 months

Other Outcomes (1)

• Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care

  6 and 18 months post-intervention

Study Arms (2)

Video-based intervention

EXPERIMENTAL

Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.

Behavioral: Video-based Intervention

Usual care

NO INTERVENTION

Interventions

Video-based Intervention BEHAVIORAL

Video clips delivered by DVD and Internet

Video-based intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported history of fracture

You may not qualify if:

• Self-reported current prescription osteoporosis treatment

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• University of Massachusetts, Worcester: collaborator
• Helen Hayes Hospital: collaborator
• Kaiser Permanente: collaborator
• Cedars-Sinai Medical Center: collaborator
• University of Pittsburgh: collaborator
• University of Cincinnati: collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Massachusetts at Worcester

Worcester, Massachusetts, 01655, United States

Location

New York University

New York, New York, 10016, United States

Location

Jewish Hospital of Cincinnati

Cincinnati, Ohio, 45236, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• Yood RA, Mazor KM, Andrade SE, Emani S, Chan W, Kahler KH. Patient decision to initiate therapy for osteoporosis: the influence of knowledge and beliefs. J Gen Intern Med. 2008 Nov;23(11):1815-21. doi: 10.1007/s11606-008-0772-0. Epub 2008 Sep 12.

  PMID: 18787907 BACKGROUND

• Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.

  PMID: 3049068 BACKGROUND

• Danila MI, Outman RC, Rahn EJ, Mudano AS, Thomas TF, Redden DT, Allison JJ, Anderson FA, Anderson JP, Cram PM, Curtis JR, Fraenkel L, Greenspan SL, LaCroix AZ, Majumdar SR, Miller MJ, Nieves JW, Safford MM, Silverman SL, Siris ES, Solomon DH, Warriner AH, Watts NB, Yood RA, Saag KG. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material. Contemp Clin Trials Commun. 2016 Dec 15;4:14-24. doi: 10.1016/j.conctc.2016.06.010.

  PMID: 27453960 RESULT

• Danila MI, Outman RC, Rahn EJ, Mudano AS, Redden DT, Li P, Allison JJ, Anderson FA, Wyman A, Greenspan SL, LaCroix AZ, Nieves JW, Silverman SL, Siris ES, Watts NB, Miller MJ, Curtis JR, Warriner AH, Wright NC, Saag KG. Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. J Bone Miner Res. 2018 May;33(5):763-772. doi: 10.1002/jbmr.3395. Epub 2018 Feb 26.

  PMID: 29377378 RESULT

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Low rates of osteoporosis treatment initiation; Self-reported fracture history subject to recall bias; Low % of participants reported fracture in 12-months prior to intervention; Low % of participants who interacted with intervention appreciably

Results Point of Contact

• Title: Dr. Elizabeth J. Rahn
• Organization: University of Alabama at Birmingham

rahneli@uab.edu

2059966552

Study Officials

• Kenneth G Saag, MD, MSc

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 24, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2016
• Last Updated: June 26, 2018
• Results First Posted: June 26, 2018

Record last verified: 2018-05

Locations

US (7)