RESEARCH QUESTION: To assess the (cost-) effectiveness of a multi component adherence intervention (MCAI) in patients with a recent fracture who need anti-osteoporosis treatment according to Dutch treatment recommendations.
HYPOTHESIS: The MCAI is expected to improve medication adherence and decision quality, and to be finally cost-saving compared to usual care.
STUDY DESIGN: A one-year trial will be conducted to compare the effects of the MCAI with usual care in two FLS clinics. To avoid contamination problems of nurses’ knowledge about the DA and the adherence support program, patients will be first assigned to usual care arm then to the intervention.
STUDY POPULATION: All patients >=50 years with a recent fracture having osteoporosis who present at the Fracture Liaison Service (FLS) at MUMC+ and VieCuri Medical Centre.
INTERVENTION: The MCAI combines a patient decision aid (DA) with a nurse-led adherence support program including one extra FLS visit. In the intervention group, participants will be guided in their decision by using a DA administered by the nurse. At the 6-8 weeks, patients will visit the nurse that will specifically inquire about therapy adherence using a motivational interviewing technique. In addition, an extra visit will be planned at 6 months.
OUTCOME MEASURES: The primary outcome of the study is medication persistence (defined as the proportion of patients without a medication gap of more than 4 weeks) measured based on actual delivery by the patients’ pharmacy. The lifetime cost-effectiveness model will be expressed in cost per quality-adjusted life years gained. Secondary outcomes include decision quality, health status, uptake of drugs, quality of life and costs.
SAMPLE SIZE/DATA-ANALYSIS: A total of 210 patients will be included. Statistical analysis will be conducted according to the intention-to-treat principle, and a Markov microsimulation model will be used for the economic analysis. In addition, a process evaluation will be conducted.