Section overview
This section reports the progressive analysis of the literature and interviews, from foundational work on understanding the complexity of medication management to the generation of burden-centred programme theory. It begins with the realist review, augmenting the description of medication management before setting out initial CMO configurations. Findings from the realist evaluation are reported next, highlighting interviewee’s experiences of tasks, routines and outcomes, followed by CMO configurations based on their accounts. Finally, the data synthesis reports the combined analysis of the data sets, addressing the complexity of the medication management process through a five stage, four step, three-loop structure. Informed by Normalisation Process Theory and viewed through the lens of ‘burden’, five burdens were identified from the analysis of CMO configurations for Stage 5: Reviewing/reconciling medication. The progressive focussing of analysis in a realist approach was fundamental to the generation of MEMORABLE’s theoretical framework, concluding this section.
Despite the linear way in which these findings are presented, analysis involved numerous iterations to address the complexity of the topic, refine the scope and processes of medication management and theorise about burden within it.
Realist review findings: understanding the breadth of medication management (Work Package 1)
Literature on the complexity of medication management
Medication management aligns with the Medical Research Council criteria as a complex intervention (50). The review screening processes reduced the initial returned articles from 1018 to 24: see Figure 2 (51).
INSERT Figure 2: PRISMA Flow Diagram: medication management
These 24 articles (from 2009-2017), were selected for final analysis being judged as most likely to contain the relevant data needed to build an initial programme theory of medication management. In other words they contained data on: ‘concept’ (n=4) (52–55); ‘framework’ (n=5) (56–60); ‘model’ (n=9) (61–69); or ‘theory’ (n=6) (70–75): see Figure 2. Table 1 sets out details of these documents.
INSERT Table 1 HERE
Potentially significant factors but limited causal links were identified in the texts. These factors included the importance of older people’s medication management workload (17,18,56), highlighting the influence of diagnoses, symptoms and illness trajectories that overlay ageing processes (11–13,55); the medications they take, including high risk drugs, doses and complex regimes (7,10,20,56); and relationships with prescribers (56,58,60). Without explaining how, these factors were believed to contribute to behavioural responses such as self-efficacy, coping styles and control: ‘personalised, contingent and contextually situated…highly individualised routines and strategies’ (52). Tentative links between ‘the overburdened patient’, poorer adherence and worse outcomes began to emerge (13–15,76–81).
The role of doctors (52,54,56), and increasingly pharmacists (57,59,61) and nurses (52,56), was central to prescribing (53,55,56), de-prescribing (53,59) and information-giving (56,59,62,65). Trusted therapeutic relationships (54,56,65) were valued for their continuity (82), addressing service and organisational fragmentation (5). Shared decision making (83–88) was increasingly recognised for the way it enhanced practitioner contacts (9,34,89). In these circumstances, practitioners appeared more likely to be able to influence older people’s ‘decision architecture’ (90) and therefore what they did at home: ‘enhanc(ing) self-management capacity regarding medication use’ (67).
Initial theorising about medication management: setting out preliminary CMO configurations
Semi-structured patterns of causal factors were abstracted from these 24 articles and mapped as preliminary CMO configurations; 10 in total. Examples include the way that polypharmacy increases the risk of adverse drug events through the physiology of ageing (Lit CMO 01); medication adherence is increased when control is given to carers (Lit CMO 02); and adherence to disease specific guidelines increases polypharmacy when practitioners follow evidence-based than person-centred practice (Lit CMO 03).
Realist evaluation findings: increasing the focus on implementation and causality (Work Package 2)
Experiences of medication management: tasks, routines and outcomes
50 interviewees described and then explained their experiences of medication management: see Table 2 for interviewee characteristics.
INSERT Table 2 HERE
Analysis validated and extended the results of the review, augmenting the understanding of implementation. Key areas found during analyses were: first, the diverse range of purposeful implementation work, day-to-day tasks and routines interviewees were involved in; and second, outcomes that interviewees identified as important to them.
First, interviewees described their workload, potentially burdensome, including:
- older people: making and attending appointments, including organising travel to and from surgeries and hospitals; arranging blood and other tests, and following up results; getting a prescription and having it filled at a local pharmacy; sorting tablets into daily, weekly or monthly containers and typically locating containers in the kitchen to prompt them about tablets that go with food; following a flexible medication management routine to fit with day-to-day life and unexpected events;
- family carers: providing physical assistance with appointments, collecting or taking medications; providing cognitive support to ensure medications are taken, prescriber recommendations followed and sufficient supplies maintained; encouraging and advocating for their family member; and
- practitioners (role-performance based): formal carers adhering to local policies and individual care plans for prompting or administering, and reporting medication-taking; a social worker assessing self-medication skills and using Care and Support Planning to meet changing levels of need; general practitioners presenting treatment options to engage older people in decision-making about medication and checking adherence; geriatricians/acute teams getting accurate, timely medication lists on admission and providing revised lists on discharge; nurses and pharmacists carrying out reviews based on a single diagnoses or medication.
Second, interviewees described diverse outcomes associated with medication management that mattered to them and were potentially motivating, including:
- older person: “I can be normal and go out and do things and play with our grandson and cook meals and live a life.” (OP5);
- family carer: “I want them to keep his condition steady… I can cope with that… and being safe.” (C14); and
- general practitioner: “The patient still needs and is benefiting from that medication… hopefully doing more good than it is harm… based on current guidance… cost-effective, in terms of a brand or generic prescribing… the patient has the ability to, kind of, understand why they are taking it.” (P25).
Further theorising about medication management: validating and extending CMO configurations
Forty-nine CMOs were developed based on the interview: 17 CMOs were generated from older people’s interviews, 16 from family carers’ and 16 from practitioners’ accounts. Examples include how older people access healthcare when they think their health or medication is disrupting day-to-day lives and independence, so they regain control (OP CMO 01); family carers increasingly getting involved when they identify health and care problems or gaps, by responding to what is needed (C CMO 3); and how practitioner consistency enables older people to improve the way they manage complexity and risk when dealing with several long term conditions (P CMO 16).
Data synthesis: moving towards an understanding of burdens in medication management
Further analysis aimed at bringing together both datasets in order to develop a coherent understanding of medication management culminated in the following key explanatory findings.
Medication management: identifying five stages and loops between them
Medication management was refined into five functional stages: (for more information see Additional File 3).
- Stage 1: Identifying a problem.
- Stage 2: Getting a diagnosis and/or medications.
- Stage 3: Starting, changing or stopping medications.
- Stage 4: Continuing to take medications.
- Stage 5: Reviewing/reconciling medications.
These stages reflect how an older person or their family carer might recognise a health change, perhaps a new symptom (Stage 1) for which they consult a health practitioner (Stage 2). Issued with medication, they then start their new tablets (Stage 3), making them part of their day-to day routine and continuing with their medications (Stage 4), subject to regular review (Stage 5).
Within such an apparently simple scenario, interview data was invaluable in identifying ‘hidden’, dynamic iterations and loops across stages (see Additional File 3 for further details).
Interview data also helped to better understand interviewees’ workload and burdens:
- older people: the importance of routines and fit with day-to-day life that are indicative of coping with burden, particularly when continuing to take medications in Stage 4; the value attributed to enduring, mutually trusting relationships in Stages 2 and 5; and how practitioner-initiated changes reverberate through existing routines and coping, impacting on initiation work (Stage 3) and sustaining work (Stage 4), with associated emotional, cognitive or behavioural disruptions or loops;
- family carers: the stress and risks of their ambiguous ‘informal’ role, evolving and infiltrating all stages, and the lack of training and support they receive. This contrasts with formal carers working under contract, who are trained, supervised and managed to undertake the same, and sometimes more limited, medication management tasks; and
- practitioners: the way Stage 5 can loop back to Stage 2 for further diagnostic work or to Stage 3 where medications are changed: See Additional File 3, and the complexity inherent in their formal medication management work to diagnose, prescribe and review in Stages 2 and 5, transacted in time-limited, influential contacts. Health and care practitioners acknowledged increases in caseloads and more complex cases, as well as performance and delivery pressures.
Medication management: identifying four steps in each stage
Interview data were also key to exposing another ‘hidden’ aspect of the medication management process; initiating and sustaining work within one or more of the five stages, interpreted through and adapted from Normalisation Process Theory (47,49):
- sense making: finding meaning in events, artefacts or relationships: ‘coherence work’ (47):
- older person: “I don’t think it’s difficult… I quite understand a lot of my drugs as well which helps… interested in the drugs, in what they do and what they’re for… I read the leaflets, yes.” (OP19);
- relationships: interacting with others and valuing continuity: ‘relational work’ (47):
- practitioner – general practitioner: “In terms of decision making, you’re the person best placed to make decisions, if you would recognise things that another clinician might not… what this person’s normally like or how they normally would present… situations where we’ve been here before… if you’ve seen that person a lot you’ll remember that and you’ll remember how you managed it last time. And the medical records don’t give the story.” (P53).
- action: doing tasks: ‘operational work’ (47):
- older person, living with mild dementia: “I know what medication I get, I know that I can get it collected every month, and I’m the one who sticks it in the boxes so I know when to take it… I think the process is important and the routine is important – that’s the key bit really.” (OP10); and
- reflection / monitoring: thinking about what happened and its effect / recording and reporting impact: ‘appraisal work’ (47):
- reflection:
- family carer: “I’ve walked out of the appointments feeling really sad, thinking “I’m really angry with the way I’ve been treated and the fact that I let it go.” (C15);
- monitoring:
- practitioner – pharmacist: “We’d follow NICE guidance with a view to what medication our elderly patients should be on… an area prescribing formulary as well… evidence as to why we have done something.” (P1).
These steps highlight important processes that underpin behaviours around health and medication, as well as pointing to key individual characteristics and capacities. Thus, in managing their medication and interacting with practitioners, some older people or family carers have capacity to respond and be motivated by information-giving and trust- or confidence-building strategies that impact a sense of control, while others are more action focused. Diminished capacity in any of these steps might lead to being overburdened and not coping with the workload.
Theorising on Stage 5 and burden: focused analysis of CMO configurations
Theorising on Stage 5: From the 59 CMO configurations generated by the analysis, four CMOs from the literature directly related to practice-performance in Stage 5: Reviewing / reconciling medications:
- When practitioners carry out a medication review using an evidence-based review tool (C), they are more likely to identify and discontinue high risk medications and simplify regimes (O) because they are confident making decisions (M) (Lit CMO 04);
- Regular medication reviews and transition reconciliations by experienced practitioners (C), optimises medication management (O), by minimising the risk of treatment related problems (M) (Lit CMO 05);
- When practitioners carry out a medication review in an older person’s home (C), they are more likely to identify medication related problems (O), because they understand people's lived experiences and they take more time (M) (Lit CMO 06); and
- Pharmacists carrying out a home medication review (C) are more likely to identify and resolve medication related problems (O), because of their particular expertise and experience (M) (Lit CMO 07).
Additional, more generalisable CMOs were also found to apply to this stage, such as:
- Practitioners, older people, informal carers are likely to make better decisions about medication (O), strengthen their relationships (O) and achieve continuity of care (O), when they collaborate through shared decision making (C), because of mutual trust (M) (Lit CMO 08); and
- Information technology used by older people, informal carers and practitioners (C) improves access, information sharing and support (O) by reinforcing communication (M) (Lit CMO 09).
Burden: burden was identified as a potential key topic early in MEMORABLE and confirmed as the research progressed, linked to medication management workload and capacity (13,15,49,79). The researchers established links between concepts of burden, coping and risk, illustrated in Table 3, highlighting a possible burden-coping dynamic and risk association with increasing/high or decreasing/low workload and capacity. The lens of burden was applied to this part of the research.
Burden was a key concern, such as when older people and informal carers described multiple health and care contacts for reviews across different sites, services, teams and practitioners, and the time and effort involved (OP CMO 15). Here the workload involved getting to, and participating in a review at their practice or at a pharmacy; having to visit a phlebotomist for blood tests at their local practice or hospital prior to their review; and seeing a doctor, nurse or pharmacist for the actual review but their doctor or hospital consultant for follow-up. The researchers also identified other hidden burdens, applicable to this stage, where there might be opportunities for mitigation by practitioners. Examples include:
- knowing what is happening and why: confidence in services reduces worry when people can rely on them (OP CMO 17);
- having information: when informed about complex medications and regimes, people feel in control, making these processes routine and less likely to be forgotten (OP CMO 04);
- minimising change: practitioner trust and consistency reduces worry because older people and carers feel understood and supported (OP CMO 12);
- minimising transitions: service and practitioner stability helps practitioners and family carers to cope because they are less distracted by fragmentation (P CMO 14); and
- being engaged: when family carer’s role, responsibilities and needs are not recognised and systems are unclear, and they are expected to cope, they feel undervalued and unsupported (C CMO 13).
Identifying five burdens
In order to consolidate the findings above with a specific focus on the impacts of medication management on older people, further analyses were performed and five burdens were identified from the analysis described above (see Additional File 4 for exemplar quotes illustrating these burdens):
- ambiguity burden when the purpose, practice and benefits of reviewing / reconciling medications
within medication management is not explained, limiting this stage’s contribution to their health and wellbeing. This aligns with ‘clarification’ work during sense making;
- concealment burden due to a lack of information that prevents older people and family carers from understanding, personalising and using what they want or need to know. This relates to ‘information’ work during sense making, contributing to how people use knowledge to increase a sense of personal efficacy, agency, control and coping;
- unfamiliarity burden from not seeing the same practitioner consistently. This concerns relationships and establishing foundations of mutual trust through continuity. It also encompasses unfamiliarity with changes to services and staffing in organisations and systems that are in a state of flux, such as from reorganisations and improvement initiatives;
- fragmentation burden from being seen by several practitioners working across separate services and organisations, potentially limiting how older people and family carers are understood and how their complex and subtly changing needs are addressed. This relates to a breakdown in face-to-face relationships and communication, including inter-practitioner collaboration, within and between services and organisations, exacerbated by boundaries and transitions; and
- exclusion burden when older people and family carers are not recognised for their experience and expertise, nor fully or effectively engaged in decisions that affect their health and care. This concerns action, and the lack of collaboration through shared decision making around common goals.
Burden identification and mitigation were considered to be fundamental aspects of the experience and practice of medication management.
MEMORABLE: theoretical framework
The theoretical framework, Figure 3, is the key output from MEMORABLE. It provides a high level overview and summary of how medication management impacts on those involved that draws together the findings from the above analysis process, highlighting:
- the focus on participants in medication management: primarily older people living with multi-
morbidity and polypharmacy, but also family carers and practitioners;
- the centrality of burden (workload and capacity) and types of burden, coping and risk to medication management; and
- the implementation steps that participants are involved in and the importance of the interplay between sense making, action, reflection / monitoring and relationships that are foundational to the work done and outcomes achieved.
INSERT Figure 3: MEMORABLE’s theoretical framework for medication management: understanding burden
The framework also prompts the reader to consider the potential differences in duration of stages, such as Stage 2 typically less than 10 minutes; Stage 5 perhaps up to an hour; and Stage 4, several months, if diagnoses and medications remain stable.