Keywords
Multimorbidity, process evaluation, primary care, polypharmacy, social prescribing
Multimorbidity, living with ≥ two chronic conditions, is associated with adverse health outcomes and increased health service use. The ‘Medicines support and socIal prescribing to aDdress pAtient prioritieS in multimorbidity’ (MIDAS) cluster randomised controlled trial (RCT) is evaluating the effectiveness and cost-effectiveness of two interventions aimed at improving multimorbidity outcomes in primary care: 1) MyComrade: practice-based pharmacists supporting general practitioners (GPs) to manage medicines, and; 2) LinkMM: practice-based link workers providing social prescribing support. The process evaluation will explore the implementation of both interventions in the general practice setting.
We will use a convergent parallel mixed methods design. We will assess reach, fidelity, and dose using patient questionnaires and intervention logs. Qualitative data will be collected through semi-structured interviews post-intervention in a purposive sample of GPs, practice nurses, intervention personnel (i.e., pharmacists and link workers), and patients. Mobile Instant Messaging Ethnography (MIME) will be used to collect real-time data from a subset of intervention personnel. This approach involves the research team communicating with intervention personnel via Threema (a secure instant messaging mobile application) at three phases of the intervention (beginning, middle, end). The message prompts will encourage intervention personnel to share reflections on what worked well, challenges encountered, and contextual factors influencing intervention delivery. Quantitative data will be analysed descriptively, and qualitative data using thematic analysis. Findings from both strands of data will be integrated using a triangulation protocol. Further, composite narratives will be constructed using these data to provide an overarching view of how the interventions were delivered and experienced.
The process evaluation will provide a detailed understanding of implementation, contextual factors, and mechanisms influencing the effectiveness of the MyComrade and LinkMM interventions. The findings will contribute to evidence on implementing complex interventions to improve care for people living with multimorbidity in primary care settings.
ISRCTN11585238; 17th April 2024
Multimorbidity, process evaluation, primary care, polypharmacy, social prescribing
Multimorbidity, commonly defined as the presence of two or more chronic conditions in an individual, is an increasing challenge to healthcare systems globally1. Individuals living with multimorbidity experience poorer health outcomes, including increased premature mortality, reduced functional capacity, lower quality of life, and higher healthcare utilisation2–4. Recent global estimates indicate that 37.2% of adults in community settings live with multimorbidity; with prevalence rising to 51% among people aged over 605. In Ireland, data from the Irish Longitudinal Study on Ageing (TILDA) report that 73.3% of people aged over 50 years live with multimorbidity6. Despite its increasing burden, healthcare systems worldwide remain predominantly structured around single-disease models of care, leading to fragmented and poorly coordinated management strategies for people living with multimorbidity, that exacerbate treatment burden7.
Clinical guidelines highlight the need for tailored, patient-centred interventions to address the complex and evolving needs of people living with multimorbidity8,9. Two potential avenues for intervention include addressing polypharmacy and supporting patients in setting and achieving their goals, values and priorities. Many people living with multimorbidity require multiple medications to manage their conditions, which increases the risk of adverse drug events, potentially inappropriate prescribing, treatment burden and non-adherence9,10. Best practice guidelines recommend at least an annual medication review, with more frequent reviews if clinically indicated8,9. However, systematic reviews highlight a limited evidence base for multimorbidity interventions in primary care, with studies showing mixed effects11. A Cochrane review suggests that interventions targeted at specific risk factor management, such as medicines management, may be more effective than broader case management approaches12.
Social prescribing has gained increasing recognition as a person-centred approach to address the non-medical needs of primary care patients13. Many models of social prescribing involve link workers, who are non-health or social care professionals trained in active listening and motivational interviewing14. Link workers help support patients in identifying meaningful goals, co-producing personalised action plans, and facilitating access to community-based activities and support. They also provide ongoing motivational support to help patients engage with resources and achieve their health and well-being goals14. Social prescribing link worker interventions have been widely implemented across the United Kingdom and in some areas of Ireland15,16. However, there remains a lack of robust evaluation of their effectiveness17.
Two recent pilot interventions in Ireland have explored strategies to improve outcomes for people living with multimorbidity through medicines management and social prescribing. The MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade) pilot study assessed the feasibility of collaborative medication reviews in primary care18. The Link Workers for MultiMorbidity (LinkMM) study evaluated the feasibility and potential impact of a general practice-based social prescribing link worker intervention, which aimed to enhance patient capability and engagement with community services19. While both the MyComrade and LinkMM interventions demonstrated feasibility and indicative effectiveness, further research is needed to establish their definitive clinical and cost-effectiveness.
To address this gap, the ‘Medicines support and socIal prescribing to aDdress pAtient prioritieS in multimorbidity’ (MIDAS) three-arm cluster randomised controlled trial (RCT) aims to evaluate the clinical and cost-effectiveness of these two interventions. The trial will recruit 672 patients from 48 general practices in Ireland, with practices randomised to receive (1) MyComrade, (2) LinkMM or (3) usual general practice chronic disease management. Primary outcomes will be the number of medicines per patient (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention).
As the MIDAS RCT comprises two distinct complex interventions, it is essential to examine not only their clinical effectiveness but also how these interventions are implemented. Complex interventions involve a number of interacting components and often require a degree of flexibility, or tailoring to the local environment20. The United Kingdom’s Medical Research Council (MRC) recommends conducting a process evaluation alongside effectiveness evaluations to assess how interventions are delivered and how they interact with the context in which they are delivered21,22. Process evaluations typically assess key implementation factors including fidelity (whether the intervention was delivered as intended), reach (whether and how the intended audience comes into contact with the intervention), dose (the quantity of the intervention implemented), and contextual factors that may influence implementation and outcomes21. These evaluations often incorporate both quantitative and qualitative methods to capture a comprehensive picture of intervention processes. Ethnographic approaches have been identified as potentially valuable for process evaluations, as they can help produce valid data, situate data within social contexts, and enhance theory-building23. However, traditional ethnographic methods, such as in-person observations, may not always be feasible in healthcare settings, particularly in trials with geographically dispersed intervention sites.
To address these challenges, this process evaluation will include a Mobile Instant Messaging Ethnography (MIME) approach24. MIME involves connecting with intervention personnel (i.e., pharmacists and link workers) remotely via Threema, a secure instant messaging mobile application, to collect real-time qualitative data. This method allows intervention personnel to share their experiences dynamically over the six-month intervention period, rather than relying solely on retrospective interviews post-intervention. This ongoing method enables the collection of richer data on contextual factors influencing intervention delivery over time. It also provides insight into the lived experience of personnel as they embed themselves into new roles in primary care. Compared to traditional ethnographic observation, MIME is arguably less intrusive and offers participants greater agency in deciding when and how much to disclose25.
The aim of this process evaluation is to explore the implementation of the MyComrade and LinkMM interventions and the experiences of general practitioners (GPs), practice nurses, intervention personnel, and patients involved in both the interventions, as well as the control group. Our specific objectives are to:
1. examine the implementation of the interventions in terms of:
2. examine intervention receipt and engagement by patients, including contextual factors influencing engagement
3. explore intervention delivery from the perspective of intervention personnel
4. explore the perceived effectiveness and acceptability of the interventions
5. identify unintended consequences
6. explore care as usual (as delivered in control practices)
We will use a convergent parallel mixed methods design in this process evaluation26. Results will be reported using relevant reporting guidelines, i.e., the Consolidated Criteria for Reporting Qualitative Research (COREQ)27. The evaluation will be conducted in accordance with MRC guidance21,22, and a framework designed to guide the conduct of process evaluations for cluster RCTs28. Quantitative and qualitative data collection techniques will be employed and data analyses will be conducted in isolation with integration using triangulation to gain a comprehensive understanding of intervention implementation29. The MIDAS RCT will be conducted in general practices in Ireland from November 2023 to January 2027 (ISRCTN11585238). Ethical approval for the trial and process evaluation was granted by the Irish College of General Practitioners (ICGP) (reference number: ICGP_Rec_2023_016) on 29th August 2023. The study protocol for the MIDAS trial was prospectively registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (reference: ISRCTN11585238) on 17th April 2024.
The study population will comprise participants of the MIDAS RCT and will include quantitative data from all included GP practices, intervention personnel, and patients. The qualitative study population will involve a purposive sample of patients, intervention personnel, GPs, and practice nurses across all three arms. Sampling of GP practices will consider factors such as size and location (e.g., urban/rural), while patient sampling will consider age, gender, and level of intervention engagement.
Patient participants in the MIDAS RCT will provide written informed consent during recruitment, which will include consent to participate in a follow-up interview if selected. All other study participants (e.g., GPs, practice nurses, and intervention personnel) will provide written informed consent upon invitation to participate in the process evaluation. Invitations to take part in an interview will be sent at the end of the six-month intervention period, while invitations to participate in MIME aspect of the process evaluation will be sent at the beginning of the six-month intervention period.
Sample size will be guided using the concept of information power30, which will actively consider our research question (experiences of the MIDAS RCT), and the expected similarity of knowledge amongst participants regarding the MIDAS interventions. We propose to recruit approximately 54 participants, including 20 intervention personnel, eight patients from each intervention arm, four patients from the control arm, five practice staff (e.g., GPs, nurses) from each intervention arm, and four practice staff from the control arm.
Quantitative and qualitative data sources will be used to address the objectives (Table 1).
Quantitative data
Quantitative data on reach and reported receipt of core intervention components will be collected during the MIDAS RCT via patient questionnaires and trial outcome data collection. Intervention personnel will also keep logs of their activities, which will provide further detailed information on intervention delivery in terms of the number of meetings, meeting duration, goal achievement, and resources engaged with.
Qualitative data
Interviews
After intervention delivery, qualitative semi-structured interviews will be conducted with GPs, practice nurses, intervention personnel, and patients to explore the fidelity of intervention delivery. This will include consideration of adherence to, and receipt of, the MIDAS interventions (i.e., MyComrade and LinkMM), and the influences of context on implementation during the trial from multiple perspectives. These interviews will also explore the potential to deliver both interventions in the same practice. The process evaluation will therefore inform explanation of intervention effects in the MIDAS RCT. This will allow us to refine our logic models and better understand implementation, processes of change, and the contextual and cross-cultural factors influencing system-wide implementation.
We will also conduct qualitative interviews with GPs, practice nurses, and patients in a smaller selection of control practices on study completion (to avoid contamination of control practices during the intervention period). This will give us information on usual care and developments that have occurred in routine care over the lifespan of the trial to inform our understanding of intervention effects within and across participating practices.
Topic guides will be developed for each participant group and will address aspects of intervention delivery and perceptions of participating overall. All interviews will be conducted remotely via MS Teams/Zoom and will be audio recorded. Transcription will be completed by the research team where time permits, or alternatively by a professional transcription service under necessary agreements regarding data processing and confidentiality. All identifying details will be removed from the interview transcripts, which will be password-protected and securely stored on Trinity College Dublin’s cloud server. Participants will have the option to review the transcript of their interview.
Qualitative data: MIME
Data will be collected from a subset of approximately eight intervention personnel (four pharmacists and four link workers) during the intervention period using MIME24, with selection being based on factors such as the size and location (e.g., urban/rural) of the GP practice where they are delivering the intervention. The MIME method will involve study researchers connecting remotely via Threema (a secure instant messaging mobile application) with intervention personnel, prompting them to share reflections on intervention delivery. These reflections may include what worked well, challenges encountered, and contextual factors that influenced intervention delivery.
MIME data collection will take place in three blocks of four weeks. During each block, researchers will send Threema prompts from a pre-defined theme sheet, with each week focusing on a different theme (see Table 2). Participants will have the flexibility to respond at their convenience, discuss additional relevant topics, and use their preferred format – text, voice note, or images. At the midpoint of the intervention period (week 17), participants will be invited to engage in a photovoice activity31. They will be asked to take a photograph that captures their experience of delivering the intervention and reflect on its significance. Participants will receive clear instructions to avoid including sensitive or confidential information (e.g., participants or sensitive trial data) in their submissions.
For the MIME participants, their final post-intervention semi-structured interview will include a reflexive conversation, during which they will reflect on and discuss key insights identified from the Threema-based conversation. Participants will be encouraged to review their Threema conversation prior to this interview to aid this reflexive process. For those who provide images as part of the photovoice activity, the meanings of their photos can be elaborated on further during interviews if the participant wishes to.
Research team and reflexivity
The research team consists of 13 members from a range of disciplines, including health services research, general practice, psychology, health economics and statistics. Two researchers (EK and AF), both with backgrounds in psychology, will be responsible for conducting qualitative interviews and engaging with intervention personnel as part of the MIME component of the process evaluation. To ensure consistency, one researcher will engage with the pharmacists, while the other will engage with the link workers. Both are early career researchers with experience conducting qualitative research.
Quantitative data will be analysed using descriptive statistics, predominantly frequencies and percentages.
Interview transcripts will be imported into NVivo 14 for management and analysis. Interview data will undergo inductive thematic analysis as outlined by Braun and Clarke32,33, which involves six phases (1) dataset familiarisation; (2) data coding; (3) initial theme generation; (4) theme development and reviewing themes; (5) refining, defining, and naming themes; and (6) writing up. One member of the research team will perform the thematic analysis, with findings cross-checked by other members of the research team to enhance the rigour and validity of the analysis.
MIME data will also be analysed using inductive thematic analysis. In addition, the MIME data will allow for the construction of composite narratives in concert with interview data, which will provide an overarching view of how the intervention was delivered and experienced. Composite narratives in qualitative research draw on data from multiple participants to tell a unified story framed as the perspective of a single individual34.
Photovoice images will be saved with their corresponding MIME data and interview transcripts so that they can be analysed for themes concurrently within NVivo. The research team conducting the process evaluation is the same team responsible for the MIDAS RCT. However, the trial results will not be available during the interviews with intervention participants, personnel, GPs, or practice nurses. The research team will not be blinded to the trial results during the analyses of the process evaluation data.
The development of the MyComrade and LinkMM interventions was directly informed by Public and Patient Involvement (PPI). A PPI panel, consisting of three people with lived experience of managing multiple conditions, will advise on all aspects of the MIDAS RCT, including the process evaluation. The panel has provided feedback on the process evaluation protocol and MIME prompts, and they will advise on the interview topic guides used in the process evaluation.
The MIDAS RCT aims to evaluate the clinical and cost-effectiveness of two complex interventions designed to improve outcomes for people living with multimorbidity. Given the complexity of these interventions, a process evaluation is essential to examine how the interventions were implemented, whether they were delivered as intended, and the contextual factors influencing their effectiveness. Process evaluations provide insights into implementation fidelity, mechanisms of change, and barriers and facilitators to intervention success21. By using both quantitative and qualitative data, this evaluation will provide a comprehensive understanding of how the MyComrade and LinkMM interventions function in real-world primary care settings. The findings will also provide useful information to aid the future large-scale implementation of these interventions, if proven clinically effective and cost-effective. The inclusion of a MIME as a data collection method will further enhance the evaluation by capturing real-time reflections from intervention personnel throughout the six-month intervention period. This prospective approach will complement retrospective interviews and will offer additional insight into the day-to-day realities of intervention delivery. The findings from this process evaluation will contribute to advancing knowledge on the implementation of complex interventions to improve care for individuals with multimorbidity in primary care settings.
Data generated and/or analysed during the current study that can be fully anonymised will be stored in a publicly accessible repository. Where data cannot be openly shared, the corresponding metadata will be made openly available.
This project contains the following extended data.
Doi: https://doi.org/10.17605/OSF.IO/RMK9C35:
MIDAS Process Evaluation Consent form v.2 14.01.25
MIDAS Process Evaluation MIME Consent form v.2 14.01.25
MIDAS Process Evaluation MIME Participant Information Leaflet v.2 14.01.25
MIDAS Process Evaluation Participant Information Leaflet v.2 14.01.25
Data is available under CC0 1.0 Universal.
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Cardiovascular, specifically atrial fibrillation and stroke. I have mixed methods expertise.
Alongside their report, reviewers assign a status to the article:
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Version 1 18 Jul 25 |
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