An Interventional Study to Improve Medication Adherence Using Patient Decision Aid Among Adults With Under-Replaced HypoThyroidism (IMPART): A Randomized Control Study

Patient decision aids (PDA) help people involved in decision making by providing information about the options and outcomes, and by clarifying their concerns. PDAs will help the patients to participate in decision making through SHARE approach (seeking patients' participation, helping them to explore and compare treatment options, assessing their values and preferences, reaching a decision with them and evaluating the patients' decision). Decision aids have the potential to improve adherence by enabling patient-doctor communication on treatment-related factors.

PDAs have been shown to improve medication adherence across different chronic diseases like osteoporosis and prevention of coronary heart diseases with aspirin. These aids provide patients with valuable information and support, helping them make informed choices about their treatment plans and fostering better adherence to prescribed medications. Decision Aids are available for managing hyperthyroidism caused by Grave's disease, but not for hypothyroidism. Addressing this gap could greatly empower patients with hypothyroidism to make well-informed choices about their treatment and improve their overall experience with managing this condition.

Intervention and theoretical framework According to the Capability, Motivation, and Opportunity - Behavior (COM-B) model, Capability, Motivation, and Opportunity are all referred to as "components" that influence behavior. Capability refers to the 'individual's psychological and physical capacity to engage in the activity concerned' while Opportunity refers to all those 'factors that lie outside the individual that make the behaviour possible or provoke it.' Motivation includes 'all those cognitive processes that motivate direct behavior including the habitual processes, emotional responding and analytical decision-making.' Earlier models to improve medication adherence generally highlighted the importance of doctor-patient communication and its impact on patient satisfaction, knowledge and ignorance as key determinants of medication adherence. However, studies on health behavior have constantly shown that merely providing information alone is not an effective strategy to influence behavior like adherence to medication. The COM-B model explicitly considers external resources like physical and social environment, which are typically not considered in other models like transtheoretical model of behavior change or health belief model. Jackson et al considered that COM-B model provided a more comprehensive description of adherence than other existing models, making it easier to identify appropriate interventions.

Study objectives The aim is to evaluate the acceptance, usability, understanding and effectiveness of a PDA developed for hypothyroid adults in improving their knowledge, beliefs, adherence and quality of life in patients with under-replaced hypothyroid status in primary care.

Primary objective is