Original ArticleActivating Patients With a Tailored Bone Density Test Results Letter and Educational Brochure: the PAADRN Randomized Controlled Trial
Introduction
Patient engagement, also known as patient activation, became a key component in the reformation of health-care delivery in the United States with the passage of the Patient Protection and Affordable Care Act of 2010. Patient activation “emphasizes patients' willingness and ability to take independent actions” (1) by understanding their “role in the care process and having the knowledge, skill, and confidence to manage one's health and health care” (2). Across various diseases and conditions other than osteoporosis, patient activation scores and levels predict health behaviors, with higher patient activation scores and levels being associated with better health outcomes and care experiences, and lower health-care costs 1, 3, 4. Furthermore, a growing body of evidence shows that well-crafted, patient-tailored interventions lead to statistically and clinically meaningful improvements in patient activation scores and levels and improved health outcomes 3, 4. Therefore, if the triple aim of improving the patient care experience, raising the health of populations, and lowering per capita health-care costs is to be achieved, then interventions to achieve patient activation should routinely be embedded in health-care management programs.
Patient activation may be especially important for conditions like osteoporosis, which is “a progressive systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue” (5) that increases fracture risk but is largely silent until a fracture occurs. Prevalence rates among those ≥50 yr old are 10.3% for osteoporosis and 43.9% for osteopenia (low bone mass) (6). Osteoporosis-related fractures usually occur at the spine, hip, or wrist, and frequently occur incidental to a fall (7). It is estimated that by 2025 nearly 3 million osteoporosis-related fractures will occur every year, resulting in associated health-care costs of $25.3 billion (8) as well as “premature mortality, loss of independence and function, [and] reduced quality of life” (9).
Accordingly, health-care foundations, quality assurance organizations, and federal agencies 7, 9, 10, 11 have focused on policies for decreasing the prevalence of osteoporosis and osteoporosis-related fractures. The 3 main strategies encourage healthy behaviors (adequate calcium and vitamin D intake, weight-bearing and muscle-strengthening exercise, fall prevention, smoking cessation, and avoidance of excessive alcohol intake) (7), bone mineral density testing using dual-energy X-ray absorptiometry (DXA) (12), and when appropriate, guideline-concordant pharmacological treatment. Nonetheless, older adults generally do not engage in healthy bone behaviors (13) despite aggressive federal campaigns like Senior Health (http://nihseniorhealth.gov/), Move! (http://www.move.va.gov/), and Let's Move (http://www.letsmove.gov/). Screening rates are also low with 40% of all women on Medicare reporting that they have never had a DXA (14), even though Medicare covers and encourages such testing every 2 yr (15). Pharmacological treatment rates are even lower, with recent estimates reporting that only 23.3% received pharmacological treatment within 2 yr of an osteoporosis diagnosis or any fragility fracture (16), and that only 28.5% received pharmacological treatment after discharge from a hip fracture (17), with both studies showing that treatment rates declined over time.
Because most prior efforts to improve osteoporosis health care have targeted providers with complicated interventions that have little, if any, patient involvement 18, 19, 20, 21, 22, 23, 24, 25, we designed a pragmatic randomized controlled trial (RCT) known as the Patient Activation After DXA Result Notification (PAADRN) study (NCT-01507662). The PAADRN's primary focus was to evaluate whether a simple, scalable patient activation intervention improved guideline-concordant pharmacological treatment as the clinical endpoint. Based on patient activation theory 1, 2, 3, 4, we assumed that timely, direct-to-patient communication of DXA results and fracture risk would inform patients about osteoporosis, activate them to be more proactive in their interactions with health-care providers, and improve their adherence with guideline-concordant pharmacological treatment. In this article we test whether our intervention improved patient activation scores and levels.
Section snippets
Design
The PAADRN was a pragmatic, double-blinded RCT, in which patients either received a postal mailed tailored-letter with their DXA results accompanied by an educational brochure plus usual care or usual care alone (26). Patients 50 yr old or older and presenting for DXA testing between February 2012 and August 2014 at the University of Iowa (UI), the University of Alabama at Birmingham, and Kaiser Permanente of Georgia (KPGA) were eligible to enroll. Age-eligible patients were excluded if they
Results
The Consolidated Standards of Reporting Trials (CONSORT) patient flow chart and descriptive baseline data for the covariates have been published elsewhere (31). To summarize, about 54% (7749) of the 14,280 patients known to be eligible for the study consented to participate and were enrolled. Follow-up interviews were completed by 86.8% at 12 wk and 77.7% at 52 wk. In general, there were no meaningful differences between patients assigned to the intervention and usual care groups on the
Discussion
The PAADRN was a pragmatic RCT whose primary clinical endpoint was to improve guideline-concordant pharmacological treatment, along with several secondary and tertiary outcomes among patients presenting for DXA testing at 3 clinical sites 26, 31. Based on patient activation theory 1, 2, 3, 4, we assumed that timely, direct-to-patient communication of DXA results and fracture risk would inform patients about osteoporosis, encourage them to be more proactive in their interactions with health-care
Acknowledgments
This work was supported by R01 AG033035 to Dr. Cram and Dr. Wolinsky from the NIA at the NIH. Dr. Cram is also supported by a K24 AR062133 award from the NIAMS at the NIH. Dr. Saag is also supported by a K24 AR052361 award from the NIAMS at the NIH.
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Cited by (6)
What are the contents of patient engagement interventions for older adults? A systematic review of randomized controlled trials
2018, Patient Education and CounselingPatient-reported reasons for nonadherence to recommended osteoporosis pharmacotherapy
2017, Journal of the American Pharmacists AssociationCitation Excerpt :PAADRN was a double-blinded, pragmatic, randomized controlled trial examining the effects of a patient-activation intervention on osteoporosis pharmacotherapy, patient satisfaction, osteoporosis knowledge, and quality of life. The study design, randomization procedures, outcome measures, and results for several of the primary outcomes have been reported previously.18-22 The study protocols and consent procedures were approved by each participating site’s institutional review board.
Effective communication regarding risk of fracture for individuals at risk of fragility fracture: a scoping review
2022, Osteoporosis InternationalEffective risk communication and improving adherence
2021, Osteoporosis Treatment: A Clinical OverviewSex differences in osteoporosis self-efficacy among community-residing older adults presenting for DXA
2019, Osteoporosis InternationalEvaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial
2018, Journal of Bone and Mineral Research
Role of the sponsor: The NIA, NIAMS, and NIH had no role in the (a) design and conduct of the study, (b) collection, management, analysis, and interpretation of the data, (c) preparation, review, or approval of the manuscript, or (d) decision to submit the manuscript for publication.
Trial Registration: clinicaltrials.gov identifier NCT01507662.
Disclosures: FD Wolinsky, Y Lou, SW Edmonds, SF Hall, MP Jones, P Cram, and DW Roblin have no conflicts of interest. NC Wright has received unrestricted grant support from Amgen for work unrelated to this project. KG Saag has received grants from Amgen, Eli Lilly, and Merck, and has served as a paid consultant to Amgen, Eli Lilly, and Merck unrelated to this project.
Additional contributions: We thank Rebecca Burmeister, MPH (University of Iowa [UI]), Mollie Giller, MPH (UI), April Miller, RT (UI), CBDT, Amna Rizvi-Toner, BA, BS (UI), Kara Wessels, BA (UI), Brandi Robinson (Kaiser Permanente of Georgia [KPGA]), Akeba Mitchell (KPGA), Aimee Khamar (KPGA), and Roslin Nelson (KPGA), and all of the staff at the Iowa Social Science Research Center for recruiting and interviewing all study participants. All except Ms. Miller were compensated from grant funds for their time. We also thank Ryan Outman, MS (University of Alabama at Birmingham) for coordinating and facilitating recruitment of study participants. We also thank Thuy Nguyen, MS (UI) for managing trial data. Finally, we thank the 7749 patients who participated in the PAADRN.
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Jeffrey R. Curtis, MD, MPH; Sarah L. Morgan, RD, MD, CCD, FACP; Janet A. Schlechte, MD; Jessica H. Williams, MPH, PhD; David J. Zelman, MD.