Our overarching research question is “what should pharmacists and other healthcare professionals be recommending in relation to PHIMed?”
To answer this question, we need to explore perceptions of patients, carers and healthcare professionals around the use of PHIMed, its key features, barriers and facilitators to its use, how it is currently used, and the important features of both PHIMed tools and how they are used in practice. The findings of the present study will also allow us to design a future randomised controlled trial of PHIMed on health-related outcomes including measures of patient activation, adherence, medication error, medication-related harm and hospital admissions based on an optimal PHIMed solution.
Aim and objectives
Our aims are to identify how PHIMed is used in practice, barriers and facilitators to its use, and key features of PHIMed that support medicines optimisation in practice, leading to the development of more effective PHIMed for testing in a future trial on health outcomes.
Specific objectives, mapped against relevant work packages (WPs) are as follows:
- To explore the perceptions of patients, carers and healthcare professionals around the barriers and facilitators, benefits and unintended consequences (both positive and negative), and key features of PHIMed (WP1);
- To document how PHIMed is currently used in practice by a stratified sample of PHIMed users (WP2);
- To identify key PHIMed features likely to be required to support medicines optimisation in routine practice (WP1 and WP2);
- To describe the current PHIMed tools used / available within the UK, both paper and electronic, and the extent to which these provide or facilitate the key features identified (WP3);
- To inform development of a PHIMed solution for testing in a subsequent randomised controlled trial of the effects of PHIMed on health-related outcomes in line with the MRC complex interventions framework (WP4);
- To make initial recommendations to patients, carers, policy makers, pharmacists and other healthcare professionals in relation to the current use and future development of PHIMed (WP4).
The study will lead to patient and carer benefits through a better understanding of how PHIMed should be used, and its likely benefits, as well as guidance for pharmacy staff and other healthcare professionals on what to recommend in relation to PHIMed.
The risks of poor information transfer across health settings are well documented, particularly for medication. It has been estimated that up to 60% of patients admitted to hospital have at least one discrepancy on their admission drug history. While there are relatively few UK studies, in March 2007 the National Reporting and Learning System for England and Wales reported 7,070 medication errors involving admission and discharge with 2 fatalities and 30 that caused severe harm. Empirical studies suggest that in the hospital setting, prescribing errors are most likely at admission, largely due to challenges of medication reconciliation. An audit of more than 8,600 patients across 50 acute hospital trusts found that when medicines were checked after admission, most patients had at least one omitted drug or wrong dose. Earlier estimates suggested that between 30 and 70% of patients have either an error or an unintentional change to their medicines when admitted to hospital. Problems are also common following transfer from hospital into the community and when attending outpatient appointments. A survey completed by 113 London GPs to identify priorities for improvement of medication safety in primary care identified incomplete reconciliation of medication as the highest priority.
Increasing patient (and carer) involvement with their medication records is a potential approach to improving information transfer across settings. There is increasing awareness of the importance of patient involvement and activation, where patient activation describes the knowledge, skills and confidence a person has in managing their own health and care, reflecting attitudes and approaches to self-management and engagement with healthcare. It is widely recognised that people who feel in control, empowered and confident have better outcomes. Supporting greater patient involvement is a fundamental component of ‘person-centred care’, a key feature of NHS England’s Five Year Forward View as well as being advocated by leading patient groups. A recent systematic review of carers’ roles in preventing and facilitating medication errors in domiciliary settings shows that medication administration errors made by carers are a potentially serious patient safety issue and recommended better communication between carers and healthcare professionals. It is therefore important to consider how to optimise patient and carer involvement in transferring medication related information across care settings.
Although patients (and their healthcare professionals) are increasingly able to access their GP medication records, these do not include over-the-counter or some specialist medication, are sometimes inaccurate and may have limited functionality, and many prefer something hand-held. As a result, many people who take medication use various types of PHIMed. This may be paper or electronic, and may be based on formal documents from healthcare providers, co-produced between patients and healthcare professionals, or informal documents created by patients themselves.
There are a plethora of examples of such PHIMed available for use. Examples include My Medication Passport, ThinkSafe, Microsoft Health Vault, the Lions Club International “Message in a bottle”, “My Medicine My Choice My Record” for care home residents, and other apps available within the Apple and Android app stores.
However, it is not known how PHIMed is used in practice, nor its key “active ingredients” in terms of what is comprises and how it is used. As with many healthcare interventions, any benefits may arise due to the tool itself, or to the wider context, such as through the conversations and thought processes it stimulates and facilitates. This distinction has been referred to as the “hard core” and the “soft periphery” of an intervention. Understanding the likely mechanism of action and an associated logic model are therefore important to optimise PHIMED tools.
The present need for research
Discussions with patients and carers within North West London have highlighted transfer of information about medicines and the use of patient-held records as priority areas for research.
We therefore conducted a preliminary literature review in March 2016 to identify and evaluate studies that have investigated the implementation, sustainability and/or evaluation of PHIMed. We searched the databases EMBASE, PubMed and International Pharmaceutical Abstracts, with search terms including the following: documentation, medicine, card, steroid, insulin, warfarin, medication passport, medication helpline card, self-documentation, self-reporting, and medication card. Research studies, conference articles, case reports, audits and service evaluations that evaluated the implementation and sustainability of either medication passports or medication record cards were included. Five studies were identified, two of which focused on medication-specific information and were therefore out of scope of the present study. Of the remaining three studies, two focused on My Medication Passport and one on generic information that patients bring into hospital. All were UK-based. Collectively, these studies suggested that many patients brought some information about medicines with them to hospital, although this was rarely a formal document and there was little information about how it should be used or its key features. Suggested barriers to successful PHIMed implementation included confusion over who was responsible for updating it, lack of understanding as to its purpose, practicalities such as whether it fits into a pocket and lack of space to record important details including patient preferences for administration.
While this literature review identified a small number of barriers, there has been no formal study of the barriers and facilitators to use of PHIMed. For example, barriers may include patient and carer assumptions that since nearly 100% of GP surgeries and 69% of hospitals use electronic prescribing, this information is automatically available to all healthcare professionals, the view that maintaining medication records is the role of healthcare professionals, previous reactions or discouragement by healthcare professionals, health literacy, concerns about inaccurate records, design barriers or information governance concerns. Facilitators may include encouragement by healthcare professionals, other patients or family members, a desire to take ownership and active involvement within healthcare, an organised approach to other aspects of health, and previous experience of the problems of fragmented medication records within health and social care.
Our overarching research question is “what should pharmacists and other healthcare professionals be recommending in relation to PHIMed?”
Specific research questions that we will explore include:
- What are the perceived barriers and facilitators, benefits and unintended consequences (both positive and negative) of PHIMed?
- How is PHIMed currently used in practice?
- What are the key features of PHIMed, both in terms of the tools themselves and how they are used, that likely to be required to support medicines optimisation in routine practice?
- What current PHIMed tools are used / available within the UK, both paper and electronic, and to what extent do these provide or facilitate the key features identified?
- How do patients and carers integrate information within PHIMed with information in their electronic health records in both primary and secondary care?
- What are the advantages and disadvantages of paper versus electronic PHIMed solutions?
- What should be the optimal PHIMed solution for testing in a subsequent randomised controlled trial of the effects of PHIMed on health-related outcomes?
- What recommendations should be provided to patients, carers, policy makers, pharmacists and other healthcare professionals in relation to the current use and future development of PHIMed?
How results of the study will be used
Our study will provide initial recommendations around the present use of PHIMed to support patient care as part of medicines optimisation, and inform development of an optimal PHIMed solution for testing in a future controlled trial to test the impact of PHIMed on health-related outcomes including measures of patient activation, adherence, medication error and medication-related harm.
We will conduct a mixed methods descriptive study. Qualitative interviews and focus groups will enable us to identify perceptions around the key components of successful PHIMed; further qualitative and quantitative methods will then allow us to explore how PHIMed is used in practice and the extent to which current PHIMed solutions meet the requirements identified.
The study has five work packages (WP). The first (WP0) comprises initial preparatory work; the remaining four (WP1-4) involve empirical data collection and analysis, and fit within the development phase of the MRC framework for complex interventions.
We will include patients, carers and healthcare professionals from the greater London area. Patients will have at least one long term condition for at least one year, and at least one prescribed medication. We will focus on the frail elderly, children with allergies and people with Parkinsons Disease, sickle cell anaemia cancer, lung disease and learning disabilities.
Definition of PHIMed
We define PHIMed as any patient-held information that allows for an editable list of current medications to be carried, regardless of whether or not other functionalities are also available. We include both paper and electronic tools, including printed repeat medication lists. We exclude supplies of patients’ own drugs (including those in compliance aids), drug-specific tools such as warfarin booklets, patient portals allowing access to GP or hospital medical records, and medication reminder apps that do not support documentation of a list of current medication.
Communication about medication involves information processing across people, tools and artefacts. Distributed Cognition is a theoretical framework specifically designed to understand these kinds of sociotechnical systems. It uses cognitive framing, based in information processing concepts, to explore interactions that are distributed across the social and material worlds. For example, it has been used to explore propagation and transformation of information in cockpits, how communication contributes to situation awareness in surgery, as well as medication errors in care homes. Distributed Cognition for Teamwork (DiCoT) is an adaptation of distributed cognition that facilitates its application in practice. It helps consider different information flows within the system, how they are influenced by people and the design of tools and artefacts, how information is processed over physical spaces, and how it evolves over time. DiCoT can be used to analyse interactions at the micro (individual), meso (team) and macro (organisational) levels. Hence DiCoT seems ideal to explore the design and usability of PHIMed, how it helps or hinders fragmented healthcare communication, and how broader organisational contexts might affect its use and effectiveness.
DiCoT supports structured analysis in the form of five integrated models: an information processing model of information flow; a social model of the roles, skills and knowledge of the people involved; an artefact model that looks at design and usability of different tools and artefacts; a physical model that focuses on the spatial arrangement of equipment and information; and an evolutionary model that explores how the sociotechnical system evolves over time. For each model, schematic diagrams are used to represent details of information transfer and the implications for wider system performance. DiCoT will therefore help explore how PHIMed: 1) supports patient cognition and interaction with healthcare professionals; and 2) helps or hinders communication and coordination in the wider healthcare system.
WP0: Preparation (3 months)
We will apply for ethics and other approvals, finalise data collection tools, and update our previous literature review.
WP1: Qualitative interviews and focus groups (5 months)
Objective: to explore patients’, carers’ and healthcare professionals’ perceptions around roles of PHIMed, key features of useful PHIMed, barriers and facilitators to its use, and any unintended consequences (both positive and negative).Methods: To explore the views of patients and carers, we will conduct two focus groups, each with 10-12 participants and about 90 minutes in duration. Adult patients (and adult carers of adults or children) will be purposively sampled to include patients with and without carers, and both users and non-users of PHIMed, to represent a range of gender, ages, ethnicities and localities. Where adult patients have carers, they will be invited to bring their carer with them or to attend separately according to their preference. Some non-PHIMed users will be included to explore the reasons for not using PHIMed and any relevant barriers. A formal sampling frame is not applicable to qualitative research; recruitment will be via our collaborating networks (section 3F). The topic guide will include questions on the roles of PHIMed, why participants started using it, key features, barriers and facilitators to its use, and actual and potential unintended consequences (both positive and negative). Participants will be invited to bring any PHIMed they use and we will (with participants’ permission) make anonymised photos or sketches of materials provided. Focus groups will be digitally recorded and professionally transcribed; notes will also be taken to aid analysis and interpretation of the transcripts.
For healthcare professionals, we will conduct 16 individual semi-structured interviews. We will use purposive sampling with the aim of creating a maximum variation sample with respect to profession, gender, age, ethnicity, locality, and previous experience with PHIMed. We envisage interviewing two GPs, two hospital doctors with experience of both inpatient and outpatient prescribing, two community pharmacists, two hospital pharmacists, two practice nurses, two hospital nurses, two dentists, and two opticians. Interviews will be conducted either in person or via telephone depending on participant preference. Questions will include experiences around use of PHIMed such as what forms of PHIMed they have seen, who documents in PHIMed, how they respond when shown PHIMed, important features, perceived advantages and disadvantages of PHIMed, and both positive and negative unintended consequences. We will also explore the extent to which healthcare professionals and patients integrate PHIMed with diagnoses and medications listed on patients’ hospital records and/or summary care records. Interviews will be recorded and transcribed.
Analysis: Transcripts will be analysed deductively with NVivo to support coding and analysis, using DiCoT as a framework,. For example, DiCoT’s social model will be used to outline how patients and carers perceive the healthcare system(s), the different professionals they interact with, and communication between them. The information flow and artefact models will be used to explore the design of PHIMed and how it integrates with other healthcare systems. The evolutionary model will be used to explore what triggers use of PHIMed and how it evolves over time. A 20% sample of analysis will be checked by a second researcher.
WP2: Documentary analysis of PHIMed use in practice (6 months)
Objective: To document how PHIMed is used in practice by a stratified sample of PHIMed users.
Methods: We will recruit a sample of 60 PHIMed users, including adults and adult carers of children, stratified according to use of digital versus paper PHIMed, and basic versus extensive PHIMed use to give four strata of fifteen participants. ‘Basic users’ will be those keeping a list of current regular medications; ‘extensive users’ will be those also recording previous medications, short term courses of medication and other information. Within each group, we will aim to include users with and without carers, as well as variation in age, gender, disease, ethnicity and number of medications. A formal sampling frame is not applicable to qualitative research; recruitment will be via our collaborating networks (section 3F). The sample size of 60 is based on four groups of fifteen participants, where 10-15 is generally considered a suitable sample for qualitative research.36 Collectively, the sample of 60 will also allow for a descriptive analysis of how PHIMed is used.
Following recruitment and consent, we will ask participants to provide an overview of all health related interactions over the last 3 months, together with details of interactions in which PHIMed was used, with whom, why, and any reactions to its use. This will take place ideally in person, at a mutually convenient venue. We will also ask participants how often they carry their PHIMed, what led them to start using it, whether and how they integrate it with their summary care record or other online NHS information via patient portals, and whether they have explored different PHIMed solutions. In addition we will view their PHIMed and ask questions to explore how up to date and comprehensive it is.
Analysis: Notes and diagrams will be subject to thematic content analysis of how PHIMed is used, what is documented and read, and by whom. We will explore use of PHIMed as a cognitive artefact, in which the tool itself captures critical features of the issues it is trying to resolve and the deeper structures of individual and team cognition. The DiCoT lens will allow us to explore the ‘soft periphery’ of PHIMed, such as how users start thinking about medical conditions, medication, and the integration of all this information, how they enter / record information and if necessary amend or delete it, and how they fashion the content in relation to their own experiences of usability and how it is perceived, received, and used by healthcare professionals. Our stratified sampling strategy will also allow us to comment on the different affordances of paper versus electronic PHIMed.
WP3: Features analysis of existing PHIMed solutions (1 month)
Objectives: to identify key PHIMed features likely to be required to support medicines optimisation in routine practice, to describe the current PHIMed tools used / available within the UK, both paper and electronic, and to document the extent to which these provide or facilitate the key features identified.
Methods: We will collate a list of desired features based on WP1/2, relevant literature, and discussion with key stakeholders. Such features might include the ability to record current and recent medication (including over-the-counter and complementary medication, oxygen and vaccinations where relevant), allergies and sensitivities, compliance aids, problems with taking medication (eg swallowing difficulties), ability to record comments about each medication, accessibility of information in an emergency, and for electronic solutions, any certification or approval, such as with the NHS Health Apps Library.39 A list of PHIMed tools will be obtained from a systematic search on the Apple app store, Google Play, Google, Pinterest, websites of patient charities such as Age UK and Patients Association, plus those already known to the research team, identified in WP1/2 or through our literature review.
Analysis: We will conduct a descriptive quantitative overview of PHIMed solutions used in the UK and mapping of the extent to which these have the features identified as important, with input from our lay partners into the extent to which usability-related requirements are met. Inter-rater reliability will be assessed using the kappa statistic. The resulting findings will largely focus on enriching DiCoT’s artefact model, while also considering the significance of features within the wider sociotechnical system.
WP4: Integrated analysis (2 months)
Objectives: to triangulate and integrate the findings, to inform development of a PHIMed solution for testing in a subsequent trial, and to make initial recommendations to patients, carers, policy makers, pharmacists and other healthcare professionals.
Methods: Findings from WPs 1-3 will be integrated and analysed using a deductive approach, with DiCoT as a theoretical framework to explore how information is recorded, used and transformed among different people and artefacts. DiCoT’s five models will be used to integrate this data to identify important patterns of structure and behaviour in this sociotechnical system, allowing opportunity for incremental and more radical design considerations and recommendations:
- The information flow model will explore interactions between patients, carers and clinicians and how PHIMed acts as an information hub;
- The artefact model will focus on PHIMed as a cognitive artefact, as well as considering other tools and artefacts used in conjunction;
- The social model will look at the nature of the healthcare networks the patient interacts with, and their perceived fragmentation or cohesiveness;
- The evolutionary model will look at what triggers patients’ use of PHIMed, how it evolves over time and the role of co-production between patients and healthcare professionals;
- The physical model will attend to system features that are affected by their spatial arrangement.
- An understanding of the perceptions of patients, carers and healthcare professionals around the barriers and facilitators, benefits and unintended consequences (both positive and negative), and key features of PHIMed;
- Insight into how PHIMed is currently used in practice;
- A list of key PHIMed features likely to be required to support medicines optimisation in routine practice;
- A description of the current PHIMed tools used / available within the UK, both paper and electronic, and the extent to which these provide or facilitate the key features identified;
- Suggestions for an optimal PHIMed solution for testing in a subsequent randomised controlled trial of the effects of PHIMed on health-related outcomes;
Initial recommendations for patients, carers, policy makers, pharmacists and other healthcare professionals in relation to the current use and future development of PHIMed.