Improvement of osteoporosis Care Organized by Nurses: ICON study - Protocol of a quasi-experimental study to assess the (cost)-effectiveness of combining a decision aid with motivational interviewing for improving medication persistence in patients with a recent fracture being treated at the fracture liaison service

Abstract

Background Given the health and economic burden of fractures related to osteoporosis, suboptimal adherence to medication and the increasing importance of shared-decision making, the Improvement of osteoporosis Care Organized by Nurses (ICON) study was designed to evaluate the effectiveness, cost-effectiveness and feasibility of a multi-component adherence intervention (MCAI) for patients with an indication for treatment with anti–osteoporosis medication, following assessment at the Fracture Liaison Service after a recent fracture. The MCAI involves two consultations at the FLS. During the first consultation, a decision aid is will be used to involve patients in the decision of whether to start anti-osteoporosis medication. During the follow-up visit, the nurse inquires about, and stimulates, medication adherence using motivational interviewing techniques. Methods A quasi-experimental trial to evaluate the (cost-) effectiveness and feasibility of an MCAI, consisting of a decision aid (DA) at the first visit, combined with nurse-led adherence support using motivational interviewing during the follow-up visit, in comparison with care as usual, in improving adherence to oral anti-osteoporosis medication for patients with a recent fracture two Dutch FLS. Medication persistence, defined as the proportion of patients who are persistent at one year assuming a refill gap < 30 days, is the primary outcome. Medication adherence, decision quality, subsequent fractures and mortality are the secondary outcomes. A lifetime cost-effectiveness analysis using a model-based economic evaluation and a process evaluation will also be conducted. A sample size of 248 patients is required to show an improvement in the primary outcome with 20%. Study follow-up is at 12 months, with measurements at baseline, after four months, and at 12 months. Discussion We expect that the ICON-study will show that the MCAI is a (cost-)effective intervention for improving persistence with anti-osteoporosis medication and that it is feasible for implementation at the FLS. Trial registration This trial has been registered in the Netherlands Trial Registry, part of the Dutch Cochrane Centre (Trial NL7236 (NTR7435)). Version 1.0; 26-11-2020.

Societal costs before and up to 1 year after the first fracture liaison service visit in patients requiring anti-osteoporosis treatments

“…For this study, patients from the usual care group of the ICON study were included. All patients attended one of two FLS centers for fracture risk evaluation [ 9 ] (Maastricht University Medical Center (MUMC +) and VieCuri Medical Center Venlo, the Netherlands). The ICON study was approved by the Medical Ethics Committee of MUMC + /Maastricht University (UM), the Netherlands, registration number 2018–0575, and the trial was registered in the Netherlands Trial Registry (Trial NL7236 (NTR7435) Version 1.0; 26–11-2020).…”

“…The Improvement of osteoporosis Care Organized by Nurses (ICON) study offers an opportunity to address the above-mentioned gaps in knowledge by collecting real-world longitudinal data on patients visiting the FLS after a recent fracture and eligible for anti-osteoporosis medication (AOM) [ 9 ]. The ICON study (trial registration number 2018–0575) was developed to test the effect of a multi-component adherence intervention (MCAI) combining a patient decision aid [ 10 ] with motivational interviewing on medication persistence compared to usual care in patients attending an FLS after a recent fracture and collected societal costs before and up to 1 year after the first FLS visit.…”

Updating and Validating the Rheumatic Disease Comorbidity Index to Incorporate ICD‐10‐CM Diagnostic Codes

“…Additionally, the RDCI is more feasible to obtain and a more versatile index, performing well in both self-reported and administrative data (1,2). Because of its performance, feasibility, and versatility, it has been broadly used in RA studies (3) as well as in studies of psoriatic arthritis (4,5), spondyloarthritis (5)(6)(7), gout (8,9), lupus (10), vasculitis (11,12), and osteoporosis (13).…”

Patient and public involvement in rheumatic and musculoskeletal research: an idea whose time has firmly come

“…Middlebrook et al [ 12 ] delved further into improving musculoskeletal trauma recovery outcomes by evaluating patients' and physiotherapists' successful recovery perceptions to ensure alignment. Salmasi et al [ 13 ] reported on researchers' perspectives in an OMERACT adherence study, while Cornelissen et al [ 14 ] shared a co-designed multi-component adherence protocol for osteoporosis care.…”