Clinical trial NCT01907269: A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
Official title: Activating Patients to Reduce OsteoPOrosiS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: University of Massachusetts, Worcester
name: Helen Hayes Hospital
name: Kaiser Permanente
name: Cedars-Sinai Medical Center
name: University of Pittsburgh
name: University of Cincinnati
First posted: 2013-07-24
Enrollment: 2684
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Self-reported history of fracture

Exclusion Criteria:

* Self-reported current prescription osteoporosis treatment

Primary outcomes:
measure: Number of Participants That Initiate an Osteoporosis Prescription Medication
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Number of Participants Who Reported Use of Calcium and Vitamin D
timeFrame: 6 and 18 months post-intervention
measure: Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing
timeFrame: 6 and 18 months post-intervention
measure: Number of Participants That Initiate an Osteoporosis Prescription Medication
timeFrame: 18 months
Other outcomes:
measure: Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care
timeFrame: 6 and 18 months post-intervention
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Worcester
country: United States
facility: University of Massachusetts at Worcester
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
city: Cincinnati
country: United States
facility: Jewish Hospital of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: University of Alabama at Birmingham
name: Kenneth G Saag, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.
citation: 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.
citation: 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.