WHAT IS ALREADY KNOWN ON THIS TOPIC

WHAT THIS STUDY ADDS

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

The IMA-cRCT was a type I hybrid effectiveness-implementation trial conducted in 24 PC centres and 37 community pharmacies within the catchment area of the 12 intervention group (IG) centres between March and September 2022, with a 1-year patient follow-up.21 22 29 30

The embedded mixed-methods process evaluation was designed following Medical Research Council guidelines for the development and evaluation of complex interventions.28 31 Therefore, it explored three interactive domains that could influence trial outcomes: (1) implementation of the intervention was explored by assessing implementation strategies or methods used to adopt the intervention, fidelity or the degree to which the intervention was implemented as intended in the original protocol and normalisation or processes through which the intervention was integrated into routine practice using quantitative and qualitative methods. Normalisation was assessed using Normalisation Process Theory (NPT) and evaluated four constructs: coherence (how professionals define and understand it), cognitive participation (how professionals engage and commit to sustaining it), collective action (how professionals put it into practice) and reflexive monitoring (how professionals assess and monitor it)32; (2) the intervention mechanisms of action that bring about any effects and explain the intervention logic using qualitative methods; and (3) the context that could influence implementation and its active mechanisms using quantitative and qualitative methods.

This study is reported according to the Standards of Reporting Implementation Studies (StaRI) checklist33 and the Good Reporting of A Mixed Methods Study (GRAMMS) checklist for mixed-methods research.34

The IMA intervention is a complex multidisciplinary intervention that aims to improve medication adherence and clinical outcomes and reduce cardiovascular risk, based on the non-initiation model6 19 and the principles of SDM.23 24 It promotes health literacy and SDM when the general practitioner (GP) prescribes a new lipid-lowering, antihypertensive, antiplatelet and/or glucose-lowering treatment. Nurses and pharmacists support the information provided by the GP, thus standardising the message and promoting collaboration between the professionals involved in the process. Patients could have a pre-existing therapeutic relationship with the professionals.

The intervention logic model (figure 1) illustrates the intervention implementation strategies (inputs) and intervention processes linked to Behaviour Change Techniques (BCTs)35 and the hypothesised mechanisms of action (changes to healthcare professionals (HCPs) and interprofessional collaboration and changes to patient and patient-HCP interactions) to influence adherence (intermediate outcome) and ultimately patient health outcomes. Details on intervention development are described elsewhere.21 The implementation strategies consisted of professional engagement to promote the intervention and improve attitudes towards it by holding information sessions with managers and professionals; training for professionals focused on IMA and SDM to increase knowledge and professionals’ self-efficacy, including role-playing; and intervention decision aids (leaflets and website36 translated into the most spoken languages) to support the intervention implementation and standardise practice. GPs, nurses and pharmacists were trained together to increase cohesion.

HCPs in the control group were asked to provide usual care. In this, GPs generally decide how to provide information, nurses monitor chronic treatments, and community pharmacists explore patients’ queries about the medication.

The IMA-cRCT was carried out in public PC centres and private community pharmacies in Catalonia, Spain. The Spanish National Health system provides universal coverage and is primarily tax-funded, with free access to care except for pharmaceutical prescriptions, which require co-payment.37 PC is the gateway to the public healthcare system and where most long-term CVD and diabetes treatments are prescribed. PC funding is mainly dependent on regional budgets, with generally fewer resources allocated to PC compared with hospital care. PC centres are organised into teams comprised of physicians, community nurses, other HCPs and administrative staff. Community pharmacies are private healthcare establishments of public interest.37 Their public funding derives exclusively from the dispensing of medicines and medical products. Patients are assigned to one GP and one nurse. GPs prescribe treatments using an electronic prescription system, which can only be dispensed at free-of-choice community pharmacies.22 37 The physical distance between PC centres and community pharmacies, along with poor communication among professionals and a lack of established collaborative practices, has traditionally limited direct interaction and interprofessional collaboration.38

The IMA-cRCT included over 300 professionals and 3000 patients overall. Professionals from the IG (83 GPs, 69 nurses and 58 pharmacists) completed the training and implemented the intervention over 7 months. Each PC centre had a coordinator, either a GP or nurse participating in the study, who was contacted regularly during the study period. The process evaluation sampling strategy was conditioned by the trial cluster design.

Quantitative and qualitative results were combined into a framework matrix and interpreted together.42 A final summary of findings was produced and presented to all coauthors for review, clarification and final interpretation.

There were protocol21 deviations in line with the dynamic nature of the study. Intervention protocol fidelity was to be explored through questionnaires and field diaries, but interviews were conducted to provide richer information. See online supplemental file 2 table 4 and online supplemental file 2 figure 1 for data sources and collection techniques per domain evaluated and study timeline deviations.

Table 1

Sociodemographic information on quantitative and qualitative professional samples

Table 2

Sociodemographic information on the qualitative patient sample

Qualitative results detailed the intervention mechanisms that influence participants’ behaviours (see online supplemental file 3 table 7 for details on main themes identified). Changes to HCPs and interprofessional collaboration were assessed through professionals’ experiences. Professionals’ attitudes towards SDM largely improved as they understood the importance of increasing patients’ health literacy and decision-making autonomy; “I think, in general, it should always be used. In this case, we have applied it to new treatments, but I think it always has to be there. Whatever you ask them [patients], ordering tests or anything to do with them, they have to be well informed and accept it, of course. (Nurse-2)”. Nevertheless, some professionals thought SDM could not be implemented with all patients, depending on, for instance, their bond of trust or differing patient profiles; “My experience is that for some patients it does work, but it is not for everyone. It depends on each patient’s profile. But, of course, you are deciding something about another person and I believe that the fact that the other person also decides if they want to do it, how they want to do it and so on, is very important. (GP-7)”. Individuals from all professional categories agreed that cohesion and communication did not change because of the intervention. GPs and nurses generally had favourable relationships with each other and reported it as an implementation facilitator, whereas none reported interprofessional collaboration between PC centres and pharmacies.

Changes to patient and patient–HCP interactions were assessed through professionals’ and patients’ experiences. Professionals perceived that the IMA intervention helped patients understand their disease and treatment and therefore increased health literacy; “It helps the patient a lot to position themselves, about what the disease is and what therapeutic options they have. Knowing where you are is always important. (GP-2)”. As perceived by professionals, patients asked more questions and reflected more on their preferences, which could increase patients' confidence regarding the medication. Patients with previous personal or familial pathology experiences reported no new knowledge gained after the intervention. Those who reported knowledge gained emphasised learning new information about the pharmacological treatment, adverse effects and disease complications. Nevertheless, a few patients reported that detailed information could increase their concerns; “I'm a bit of a hypochondriac and too much information is counterproductive for me. I tend to get stressed, to worry about everything, to be very emotional. (Patient-19)”. Professionals believed patients appreciated being involved in the decision, which increased patient autonomy and adherence; “Any person you let choose and decide on any aspect, you raise their self-esteem and improve compliance and improve involvement. (GP-1)”, as well as humanisation of clinical care; “Feeling that they are included and that you are treating them as people, not as numbers or diseases. (GP-11)”. However, professionals perceived not all patients wanted to be involved in the decision, and some patients expressed discomfort; “Look, I haven’t studied medicine, I have to go to medical school, study for five years, so that we could talk face to face and they could explain everything to me, it is impossible! (Patient-10)”. Patients who participated in the decision valued being involved, although some recognised that not being involved would not have altered the outcome; “If I hadn't been part of it [the decision], if she hadn't asked me about it, it wouldn’t have made any difference. But when she mentioned it to me, I said: “Well yes, if my opinion is useful, then sure. (Patient-18)”. At last, even though professionals believed the IMA intervention could improve patient–professional trust and reduce power imbalances, no participant reported relationship changes.

Contextual factors that influenced implementation and intervention active mechanisms are presented in line with the ecological model and distinguish among microlevel (patient), mesolevel (organisation and culture) and macrolevel (wider environment)41 43 (see online supplemental file 3 table 8 for details on main themes identified).

As microlevel factors, professionals defined patient profiles as facilitators or barriers to implementing SDM. They emphasised low education, financial difficulties and cultural and language differences as barriers to providing health education and involving patients in decisions. Additionally, they considered age to be an important aspect. They perceived that the younger the patient, the more willing they were to be involved in the decision; “They are usually middle-aged people, not very old, who like to participate, because they are worried. They want to participate. (GP-6)”.

As mesolevel factors, PC centre professionals highlighted longitudinality as a facilitator to SDM, enabling patients to visit the same professional regularly so decisions do not need to be made at the first consultation; “The advantage of primary care is longitudinality. If they do not want to start today, I explain it, and after two or three months, they might think about it and accept it. (GP-8)”. In addition, the fact that GPs and nurses generally work as a team and visit the same patients facilitated implementation by ensuring alignment and continuity of care. However, time restrictions and heavy workloads were cited as some of the main barriers by professionals and patients across all organisations; “I knew time was limited, it is very limited and yes, I would have liked to know a lot more. (Patient-10)”. Additionally, organisational, cultural and work-environment factors were mentioned. Some professionals recognised being accustomed to a model without patient involvement and sometimes overlooked their inclusion. Moreover, most patients interviewed did not expect the pharmacist to provide health education when dispensing a medication; “I mean, if the nurse and the doctor do their job, the pharmacist does their job by giving me the pills. (Patient-14)”.

Finally, at the macrolevel, we anticipated the COVID-19 pandemic would have been an implementation barrier. However, even though professionals reported low motivation after the pandemic, this was not the case.

This study provided valuable insights into the implementation of the IMA intervention. It illustrated how different components and contexts interacted and potentially influenced the trial outcomes, using a combination of quantitative and qualitative methods to generate deeper insights. The standardised fidelity and NPT questionnaire used showed adequate validity.

Despite this, there were some limitations. These include potential memory bias from participants, the possible over-representation of responses from professionals who were more actively engaged with the intervention, and patient recruitment being conducted by professionals, which may have led to more positive responses. Furthermore, positively skewed answers might have resulted from interviewers being members of the IMA-cRCT research team themselves. Qualitative interviews were limited to eight PC centres due to logistical constraints, which may have reduced the broader representativeness of all centres. However, the sampling strategy was theoretical and ensured variability based on the centre characteristics and the results of the pre-implementation questionnaire. At last, this study did not capture the experiences of the control group receiving usual care, which hinders the possibility to contrast these with those of the IG.

Not applicable.

This study involves human participants. The IMA-cRCT and its integrated process evaluation were approved by the drug research committee (CEIm) at IDIAP Jordi Gol, codeCEIm 21/051-P. Informed consent from the patients was obtained by simplified means in the cRCT. The IMA-cRCT is a low-intervention clinical trial where groups of subjects are allocated to the intervention groups and which satisfies all the conditions described in paragraphs 2 and 3 of Article 30 of EU regulation number 536/2014. The electronic database used meets all current legal requirements and is encrypted and pseudonymised so that researchers do not have access to data that identifies the patients or professionals. Professionals signed informed consent prior to trial commencement and consented to taking part in the process evaluation. Patients signed informed consent after recruitment and prior to the beginning of interviews. Participants were compensated for their time and travel expenses incurred in participating.