Award Title: Development of a medication adherence tool for people with bipolar disorder which will both identify non-adherent behaviour and the individual’s barriers to medication adherence
Funder: Health Education England

Abstract: BackgroundNICE recommends research to develop effective methods for identifying and addressing barriers to medication adherence. Furthermore, a recent systematic review concluded that there is a need for an adherence tool that is easy to administer, correctly identifies non-adherent patients and identifies key barriers to medication adherence.An estimated 40% of patients with bipolar do not adhere to their prescribed directions of medications. Medication non-adherence in bipolar leads to relapse, hospitalisation, functional impairment and suicidality. The probability of hospitalisation is five times or higher in non-adherent patients with bipolar.No gold standard exists for identifying and addressing medication non-adherence in the mental health population. Firstly, research has focused primarily on expert opinion regarding the barriers to adherence resulting in adherence rating scales and interventions derived from experts, instead of patient perspective. Secondly, existing scales focus on the nature of non-adherence e.g. frequency and magnitude rather than the underlying causes. Finally, there is an absence of health psychology theory underpinning the development of most scales despite this being critical for the development of any behaviour change intervention.In contrast to other rating scales, the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q) elicits from patients their likely barriers to adherence, and by mapping to the Theoretical Domains Framework (TDF) it offers evidence-based solutions to address any identified barriers. The IMAB-Q has been validated with over 600 patients prescribed cardiovascular medicines. However, its development and validation excluded the mental health population. There is, therefore, a need to provide mental health patients with the same opportunities as people with physical health problems.AimTo develop and test a tool for patients with bipolar which will both identify whether an individual is non-adherent and if so, their individual barriers to medication adherence [we are referring to this tool as an 'adherence tool']MethodI will identify barriers to medication adherence in bipolar through a systematic review. I will then explore these barriers in greater depth through focus groups and interviews with patients with bipolar and their carers. These data will inform the decision regarding whether to develop a new or adapt the IMAB-Q statements. I will then map these statements to the TDF domains e.g. a statement like 'Taking my medicines is a high priority' will be mapped to the 'Motivation' domain. These statements will be iteratively tested for face validity by healthcare professionals, medication adherence research experts, patients and carers until no further refinement is recommended. The final version of these statements will be our adherence tool.An estimated sample of 600 eligible patients is adequate for recruitment to a validation study to investigate the psychometric properties of the adherence tool under investigation. Objective measures (blood plasma levels of drug and prescribing and dispensing records) will be used to test construct validity. I will use classic test theory and item response theory to test structural validity. I will investigate test-retest reliability at two weeks with a sample of 30 patients.OutputThe expected output is a validated adherence tool for patients with bipolar to identify non-adherent patients and their individual barriers to adherence. There will be multiple routes of dissemination (e.g. publication, conferences, press, meetings) to academics, clinicians, patients and carers, the public, participants in the research and mental health advocacy groups. Patient/NHS benefitThe immediate benefit is an accurate, feasible and acceptable approach to identify non-adherent patients for targeting resource use. The intermediate-term benefit is that identifying an individual's barriers to medication adherence will guide the selection of the best intervention(s) to deploy for improving adherence. This will be explored in further research following this project.

Lay Abstract: Aim To develop a tool for patients with bipolar to find out if they are taking their medication as prescribed (adherent) and if not, what might be stopping them doing so (barriers). We are calling this an 'adherence tool'.BackgroundBipolar disorder is a long-term mental health condition which causes severe mood swings and makes it difficult for patients to hold on to a job or relationship, reduces their quality of life and increases suicide risk. Medication is the most common treatment but around 40% of patients do not take their medication as prescribed. This is called non-adherence and can cause symptoms of bipolar to return leading to hospitalisation, difficulty in daily functioning and suicides. So, it is important to find out when patients are non-adherent and then work with them, and sometimes their carer, to find the best solutions to manage their condition.We do not have one best way of finding out the reasons for medication non-adherence in a mental health population. There are some questionnaires that ask 'are you taking your medicines as prescribed?' But, we understand that some people are worried about telling healthcare professionals if they are not taking their medication. Also, knowing that someone is non-adherent does not help with finding a solution.There is a tool called the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q) which was developed and tested with patients prescribed medication for heart problems. It does not ask patients whether or not they are taking their medicines. Instead, it gives them a short list of things that might stop them from taking their medicine and asks them if they have any of these problems. When scores from all the answers are added together, it predicts non-adherent patients and the reasons for this. The IMAB-Q links each question to health psychology theory. This means that a patient's answers tell us what things we should do to help them overcome the problems they face.But, when IMAB-Q was developed, it excluded mental health patients. So, it may or may not be right for patients with bipolar since reasons for non-adherence in mental health patients may be different. For example, embarrassment and lack of motivation may be more important reasons for non-adherence in mental health patients due to symptoms of the illness.MethodI will look at existing literature and speak to patients with bipolar and their carers. I will use this information to find out whether to: Develop a new adherence tool or Adapt the IMAB-Q I will then show the new or adapted tool to healthcare professionals, research experts in medicine taking, patients and carers. I will keep making changes to this tool until everyone is happy with it. Then, I will test this tool with around 600 patients with bipolar prescribed a mood stabiliser medicine called lithium. I will ask the participants to complete the adherence tool. Using routine blood tests, I will be able to tell if the patient has been taking the prescribed amount. I will also look at the pharmacy and prescribing records of the participants. I will then compare the participant's scores on the adherence tool with the blood test results and the prescribing and/or dispensing records. These comparisons will tell me whether the adherence tool is finding non-adherent patients. After finishing my doctoral training, I plan to use the adherence tool to test a new way of finding and helping non-adherent patients in my hospital. I plan to link the questions from the adherence tool that I developed to health psychology theory. This means that a patient's answers will tell me what things we should do to solve the problems.Patients and their carers will benefit from my research as it will find non-adherent patients and their individual reasons for the non-adherence. This will help provide the necessary and appropriate support required for that individual. This will improve medication adherence and thus improve patient's outcome.Patients and public involvementPatients and carers have influenced the development and design of this research proposal. In addition to the discussion with many patients and carers (during my clinical practice and other meetings), I have worked closely with a patient and a carer to develop this research application. I will continue to seek their contribution including in recruitment process, developing leaflet, and disseminating findings.DisseminationI will tell patients, public, health care professionals and academics by writing news articles and through patients and carers engagement forums (e.g. Bipolar UK), and conferences.

Research Activity Codes: 7.1 INDIVIDUAL CARE NEEDS
Health Categories: MENTAL HEALTH