A pharmacist-led follow-up program for patients with coronary heart disease in North Norway–a qualitative study exploring patient experiences

Background Coronary heart disease (CHD) is one of the leading causes of death worldwide. Scientific literature shows that prevention of CHD is inadequate. The clinical pharmacist’s role in patient-centred care has been shown favourable in a large amount of studies, also in relation to reduction of risk factors related to CHD. We developed and piloted a pharmacist-led follow-up program for patients with established CHD after hospital discharge from a hospital in North Norway. The aim of the present study was to explore how participants in the follow-up program experienced the program with regard to four main topics; medication knowledge, feeling of safety and comfort with medications, the functionality of the program and the clinical pharmacist’s role in the interdisciplinary team. Methods We performed semi-structured thematic interviews with four patients included in the program. After verbatim transcribing, we analysed the interviews using “qualitative content analyses” by Graneheim and Lundman. Trial registration http://www.clinicaltrials.gov: NCT01131715. Results All participants appreciated the follow-up program because their medication knowledge had increased, participation had made them feel safe, they were reassured about the appropriateness of their medications, and they had become more involved in their own medication. The participants reported that the program was well structured and the clinical pharmacist was said to be an important caretaker in the health-care system. The importance of collaboration between pharmacists and physicians, both in hospital and primary care, was emphasized. Conclusion Our results indicate that the follow-up program was highly appreciated among the four participants included in this study. The results must be interpreted in the context of the health care system in Norway today. Here, few pharmacists are working in hospitals or in close relation to the general practitioners. In addition, physicians are short of time in order to supply appropriate medication information, both in hospital and primary care. Involving pharmacists in follow-up of patients with CHD seems to be highly appreciated among patients and may be a step towards improving patient care. The study is limited by the low number of participants.


Background
Coronary heart disease (CHD) is one of the leading causes of death world-wide [1]. A wealth of scientific evidence shows that lifestyle interventions, control of risk factors and use of cardioprotective drug therapies can reduce the risk of recurrent nonfatal and fatal disease and improve the chances of survival [2]. Despite this, Kotseva et al. has during three cross-European surveys (EUROASPIRE I-III) showed that secondary prevention of CHD is alarmingly inadequate with persistent smoking habits, high prevalence of obesity, inadequate control of blood pressure, lipids and blood glucose, with most patients not achieving therapy guideline defined targets [3]. In the wake of the EUROASPIRE surveys, a nurse-coordinated follow-up program for patients with CHD (EUROACTION) was initiated and rolled out as a randomized controlled trial (RCT) in eight European countries. Interpretations from the RCT include that local preventive cardiology programs adapted to individual countries is needed in order to care for coronary and high-risk patients [4].
A growing body of studies now indicates that involvement of the clinical pharmacist in direct patient care improves medical therapy and patient outcomes relevant to secondary prevention of CHD, for example blood pressure, blood lipids, prescription of cardioprotective drugs [5][6][7][8][9][10]. Despite this, few follow-up programs for patients with CHD described in literature, involve the clinical pharmacist as a one of the main stakeholders. Taveira et al. describes a Pharmacist-Led Cardiac Risk Reduction Clinic (CRCC) in the USA, where risk reduction in terms of Framingham risk score for CHD was reduced in patients participating in the CRCC [11,12]. Reilly and Cavanagh describe a successful pharmacist-nurse-run clinic for patients with cardiovascular disease in terms of optimizing drug and lifestyle therapy [13]. Lee et al. showed positive effect of a pharmacy care program (FAME) in terms of increased medication adherence, medication persistence and clinically meaningful reductions in blood pressure [14].
At the University Hospital in North Norway, a new follow-up program for patients with established CHD was developed and piloted during 2009-2011 (unpublished data). The program was run by a clinical pharmacist. The intervention group receiving follow-up finally included 49 patients. Few studies have explored patient experience with pharmacist involvement in patient care, though high satisfaction have been observed [15][16][17][18][19][20]. We aimed to explore the experience of participating patients in the follow-up program. We chose to use a qualitative approach with semi-structured interviews, because questionnaires do not widely allow for elaboration of answers. The study was performed by an undergraduate masters student in Pharmacy, and formed basis for his masters thesis in 2010 [21].

The follow-up program
Only patients with established CHD were included, meaning patients who had a diagnosis of myocardial infarction, angina pectoris, coronary artery bypass graft operation or coronary stent implantation. During a twelvemonth period after discharge from the Department of Cardiology, the clinical pharmacist had consultations with patients three times; at discharge (at the ward), after three and twelve months (at the hospital pharmacy). The meetings lasted 30-60 minutes and comprised mediation reconciliation, medication therapy review, and patient education concerning medications and lifestyle (physical activity, smoking cessation and heart-friendly diet). Identified drug related problems were communicated to the patients' physician either personally (first meeting) or by phone or letter (the two last meetings). After each meeting, patients received a written summary from the meeting in addition to laboratory results, correct medication list, information about the specific medications they were using, and individual instructions. The general practitioner (GP) received a letter with laboratory values, identified drug-related problems and recommendations on how to handle these.

Enrolment of participants
Participants in the follow-up program that had met with the clinical pharmacist at least twice were eligible for inclusion if they were living within the city boundary of Tromsø. Because of the limited time available for the masters project, we aimed to include at least four to six participants. In the period February-March 2010 the clinical pharmacist handed out written information about the study to eligible patients at the end of the consultation. To conceal patient participation for the pharmacist, the patients were asked to read the information at home and to return the signed consent paper to a third party by normal mail. A pre-paid envelope was supplied. To avoid including more than the estimated number of participants, the pharmacist recruited patients in blocks of four. If a sufficient number was not included after one recruitment block, the pharmacist was asked to repeat the procedure. The enrolment procedure was repeated four times in total, ending in March 2010 when five patients had returned their consent papers. These patients were contacted by phone and a face-to-face interview was arranged. Participants were free to choose whether the interview should be held in their home or at the Department of Pharmacy (close to the hospital). One participant withdrew before the interview because of sudden illness. Finally, two males and two females were interviewed. They were aged 47, 57, 62 and 71 years.

The interviews
A semi-structured interview guide was developed based on four main topics: How did the follow-up program influence patient knowledge about medicines? How did the follow-up program influence the patients' feeling of safety and comfort with medication? How was the functionality of the follow-up program? What did the participants think about the clinical pharmacist's role in the interdisciplinary health-care team?
To begin the interviews, participants were asked the question: "Can you tell me about the follow-up you are receiving from the clinical pharmacist?" Participants were encouraged to speak freely, in order to capture the narrative. The interviewer asked questions rooted in the main topics to elaborate, clarify and confirm understanding.
Interviews were held during February and March 2010. None of the interviewees chose to perform the interviews at home. Interviews lasted 40-60 minutes, were audiotaped and transcribed verbatim by the interviewer directly afterwards. Field notes were taken. To ensure that both the manifest and the latent content were reflected in the narratives, the interviews were listened to several times during the transcription phase. The narratives were subsequently "washed", meaning that all sentences were structured to make sense and extra words were omitted. Quotes were subsequently translated into English by the principal investigator (BHG). Translation was verified by the co-authors. To give feedback on interviewing technique and content, the whole research group read thoroughly through the first narrative before the next interview was held. The whole research group read all interviews before data analysis.

Data analysis
An initial analysis was performed by the master student using the thematic approach described as 'qualitative content analysis' by Graneheim and Lundman [22]. This approach comprises the following elements: i) reading of all texts several times in order to obtain a sense of the whole; ii) identifying units of analysis in accordance with the main topics and bringing these into texts; iii) identifying meaning units and abstracting these into condensed meaning units; iv) labelling the condensed meaning units with a code; v) comparing the codes concerning similarities and differences and sorting them into main-categories and sub-categories, which constitute both the manifest and the latent content of the interviews, vi) summarizing the contents of the main categories to generalized descriptions and experiences reflecting the most important aspects of each topic in the interview guideline. The same analysis was subsequently made by the principal investigator (BHG), and validated by the research team (SLS, LS), who agreed upon the final interpretation.

Ethics
This study has been conducted in accordance with the principles of the Helsinki Declaration [23]. Informed consents were obtained from all participants and the Regional Committee for Medical Research Ethics North Norway approved the study. Registration number at www.clinicaltrials.gov is NCT01131715.

Results
The four initial main topics were eventually reduced to three topics. The topic 'feeling of safety and comfort with medication' was merged with the topic 'experiences with the follow-up program' , based on the finding that all four participants expressed that the program itself had made their 'feeling of safety and comfort with medications' increase. In Table 1, the findings from the analysis are shown. In the following sections, condensed versions of the three final topics are given. The informants are renamed Steve (62 years) , Bryan (47 years), Claire (57 years) and Mary (71 years).

Experiences with the follow-up program
Experiences with the follow-up program were found to be characterized by its framework and execution, the pharmacist's performance and her empathic behaviour. In addition, all participants said that the program had made them feel more safe and comfortable with their medications. These experiences were categorized into 'specific' and 'abstract' experiences, the latter category covering feelings and personal opinions.
The informants described the follow-up program with words like 'great' , 'a positive experience' , 'educative' , that they felt 'safeguarded' and 'fortunate' , that they had 'received special treatment' and 'help in daily life'. All four informants stated that the follow-up program should be recommended to everybody that uses medications. Steve suggested that everybody using medications should be "You don't get enough information about medicines. So, you've really made a discovery with this program! Everybody using medications, or at least everybody who use medications after hospitalization, and who has to use medications life-long, should have this kind of follow-up" (Claire) [1] All participants expressed that they had gained new and clarifying information about their medication. Claire, Mary and Bryan even believed that their medication regime had become better and more appropriate. All participants appreciated the pharmacist's thorough knowledge about medications and her critical attitude towards them, which can be explained by the general scepticism towards medications expressed by all four participants. In fact, It seemed like they most of all did not want to use medications, or at least wanted to keep them at a minimum. In addition to the pharmacist's professional skills, the emphatic way of acting with patients played an important role when educating about medications. Mary said: "She was a human being that I could talk to. One that was professionally educated, who was skilled in supervising me about my medications and my disease" (Mary) [2] How the follow-up program was carried out seemed important to the participants. The following elements were highlighted: the generous time schedule during follow-up, the proximity to the place where meetings took place, and the fact that they received summary letters and copies of correspondence with the GP.
Bryan and Steve also preferred personal meetings over phone meetings. They said that it established a closer relationship with the pharmacist and that they could devote themselves fully to the follow-up issues without being disturbed. Mary and Bryan also felt that the follow-up program had been presented to them in a respectful way, not 'like a salesman' as Bryan stated it. Claire, Bryan and Mary also appreciated that they did not have to keep track on so many things during followup, as Bryan announced: "If I would have to write a diary, journal or remember anything in particular, like sending in reports or whatever… I doubt that I would have joined-I'm so bad in keeping track of such things". (Bryan) [3] All four informants said that they felt safe when being part of the follow-up program. The feeling of safety seemed to be related to both the pharmacist's professional skills as well as the predictability of the follow-up program. The fact that the pharmacist supplied a 'second opinion' about the medications, the availability of the pharmacist by phone, and the honest answers to questions also seemed to contribute to the feeling of being cared for. Consequently, this made participants feel safe. That the participants felt safe while participating in this program seemed to be related to their feeling of not being properly taken care of by the public health care system. Claire said: "If I had not joined this program, I would have been all on my own" (Claire) [4] Knowledge about medications All participants said that they had gained knowledge about medications in some way or another. They had increased their knowledge within the following topics: 'medication use' , 'how to take medications' and 'their own attitude towards medicines'. The latter category could be dichotomized into the well-known principles within pharmacy; 'adherence' and 'concordance' , respectively reflecting 'The extent to which the patient's behaviour matches agreed recommendations from the prescriber' and 'a consultation process, in which doctor and patient agree upon therapeutic decisions that incorporate their respective views' [24,25].
Knowledge gained by participants seemed to be founded in the thorough and comprehensible information given by the pharmacist, which was highlighted by all informants. Mary stated: "She explained in a manner so that I understood like I'd never done before" (Mary) [5] This shows the importance of communication skills and communicating with patients in a language they understand. Claire said she had become more adherent with her medication regime, as she now recognized the importance of her medications. Steve and Bryan said they had become more conscious about their medication use, which indicates a higher understanding, which is one of the cornerstones of 'the concordance principle'. Everybody expressed that they had acquired specific knowledge, either about the correct time of the day to take medications (for example simvastatin at night in order to obtain optimal effect), important food-drug interactions (for example calcium absorption may be inhibited by dietary fibre) or the drugs' intended effect (for example β-blockers to slow your heart rate). Claire and Steve also felt they had acquired knowledge about side effects (for example that 'aspirin may be hard for your stomach' and 'simvastatin may give you muscle pain'). For Bryan, the information from the clinical pharmacist had made him aware that he actually had side effects from his β-blocker: "And it struck me as a lightening, the cause of all my troubles. They were side effects of the medications I was using, sweating, headache, no energy, heart rate under 40 and very lazy…" (Bryan) [6] Bryan also told that he previously took his medications because his doctor told him so. The other participants indicated similar attitudes, which is the opposite of the 'concordance principle'. The fact that they all emphasized how important knowledge about medication was indicates that they were pleased with approaching 'concordance'. Mary said: "It's positive to know more about what you put in your mouth and swallow with water… and believe that this helps for this and that. But to know why it helps and how… that's what I think is positive. That you learn more about it, not just eat and swallow what the doctor has told you to." (Mary) [7] The clinical pharmacist's role in the interdisciplinary team The participants' experiences with the pharmacist as part of the interdisciplinary team, was frequently expressed in comparison with their experiences with the public healthcare service in general; the GP, the hospital and the community pharmacies. Our findings have to be seen in the light of the Norwegian healthcare system, where patients are not familiar with encountering clinical pharmacists. Consequently, they compare their experience with the follow-up program with the healthcare service they normally receive.
All four participants expressed that time with and information from their GP was inadequate. They said that the pharmacist had been more available for questions. Bryan called the GP system an 'on-going industry'. His argument was that that he always exited the physician's office within ten minutes after entering, including payment, feeling that the consultation is too short. Mary thought that explanations she received from her physicians were of poor quality. In fact, when the participants spoke about their GPs, they all expressed feelings like 'lack of confidence' , 'not being taken seriously' and 'given a prescription to end the appointment'. Seen in the light of such experience, it is perhaps not strange that they appreciated the pharmacist's suggestions medication amendments, and that they acknowledged the pharmacist as part of the interdisciplinary team as the one offering a 'second opinion' of their medications. Steve said: "I think it's reasonable that a pharmacist has an overview parallel to the physician's, and perhaps also has a different view on things" (Steve) [8] Bryan, Claire and Mary told that their GPs had appreciated and welcomed the pharmacist's medication recommendations. Mary said that she had actually feared a negative reaction from her GP, and indicated that GPs might experience pharmacist involvement as interfering with their area of expertise.
The participants regarded community pharmacies like more or less "normal shops", where 'you hand in your prescription, you pay and you leave' , as Bryan stated. Claire said that the follow-up from the clinical pharmacist was something totally different and that she had never experienced to get information from pharmacists in a community pharmacy. She now wanted the community pharmacists to be more available and visible in the pharmacies. Steve also felt that it would be easier to approach community pharmacists after the follow-up program.
The clinical pharmacist's role in the hospital service was acknowledged by all participants, and must also be seen in relation with their disappointment concerning follow-up from their hospital. Involvement from a pharmacist at the ward was regarded as positive because of the pharmacists' skills within medication counselling. Again, this must be seen in relation to the physicians' shortage of time. Mary said: "I think that having a pharmacist at the hospital ward would be very good. They can explain about medication use, because the doctors, unfortunately, don't have time for that" (Mary) [9] Steve also had thoughts about 'the Heart School' , which is a two-day follow-up program offered by the University Hospital of North Norway to patients that have experienced their first myocardial infarction. The program comprises group teaching by a cardiologist about CHD, by a pharmacist about medications, by a physiotherapist about physical activity and by a nutritionist about diet and heart-protective food. The patients also receive a one-to-one consultation with the cardiologist. Steve suggested that the pharmacist should also perform one-to-one consultations, in the same manner as the cardiologist. He said: "You have the physiotherapist and the expert in nutrition. You have the cardiologist, and you have the pharmacist. Those four are important, I believe… and I've experienced that, at the Heart School…. Those four should form a team. The result will be a better understanding of the relationship between medications, diet, physical activity and stress. [….] It's important that the patients with coronary heart disease get to speak with the pharmacist. This may be feasible at the Heart School. Time for personal consultations with the pharmacist must be a priority" (Steve) [10] Altogether, pharmacist collaboration with the GP and the hospital physician were appreciated and seen as important, both to inform about mediation, and to perform 'quality checks' of medication regimens. Claire thought that all patients at a cardiology ward should meet the pharmacist before discharge. Steve was also convinced about the economy in this; he thought this could make a means to get patients more rapidly back to work. Concerning medication dispensing at the community pharmacy, Steve found it troublesome if he had to return to his GP for a new prescription because the pharmacist revealed a drug related problem. This indicates that medication therapy review should be performed at the time of prescription.
Despite the positive endorsement of the pharmacists' role in the interdisciplinary health-care team, there were concerns raised by the participants regarding how different tasks should be distributed between the different members of the healthcare team. In addition, the concern for the patient having too many healthcare professional to relate to was also mentioned. Steve said: "I believe the patients will benefit from the collaboration between the physician, the pharmacist and the nurse-if it's done properly. However, the patient cannot relate with too many persons. It might not be necessary for the pharmacist to have their own consultations with the patients at the ward, but the physician must use the pharmacists' knowledge more than today… I'm sure they [the pharmacists] have more knowledge about medicines than the physicians. But the specific way to go forward can be troublesome… to find the middle way." (Steve) [11] Discussion Applying a thematic approach, this study is the first study to explore experiences from patients with established CHD with a pharmacist-led one-year follow-up program after hospital discharge. All participants highly appreciated the program, which is in accordance with findings from other studies where satisfaction with pharmacist involvement in direct patient care has been explored [15,17,19]. Time seemed to be an important factor for all participants, which must be seen in relation to their experience of shortage of time by healthcare professionals in general. Tsiantou et al. also found that time spent by pharmacist in patient relationships was as an important factor in order to increase medication adherence [18].
But time was not the only factor that contributed to the participants' positive experience with the follow-up program. As also mentioned by Tsiantou et al. and Lalonde et al., participants were interested in deeper and more comprehensible information to increase their understanding of their medications, as this had not been offered by their GP's [15,18]. All participants expressed critical attitudes towards medications, which may be one reason why the 'second opinion' from the pharmacist seemed to be of great importance. This 'second opinion' had also made them feel comfortable and safe with their medication regime. The pharmacist's ability to identify inappropriate prescribing and drug-related problems through medication therapy reviews is widely recognized and embraced by the philosophy of pharmaceutical care [26][27][28][29]. This also corresponds to the participants' acknowledgement of the pharmacist's involvement in quality checking medication regimes.
Non-adherence to medications use has been shown to be one of the most important factors for therapy failure [30]. In our study, participants stated that they had become more adherent to their medication regimes as their level of knowledge had increased. They were also interested in taking part in decision making in relation to their medications; not only obeying their doctors. It might seem like adherence with the GP's prescribing was replaced with the principle of 'concordance' during the follow-up program. However, this needs further investigation.
According to our findings, pharmacists should be involved in patient care at different levels; medication information to patients, collaboration with physicians in medication-related questions and quality check of drug regimens (both at hospitals and in community care), and individual medication consultations, for instance at the 'Heart School'. In general, pharmacists were acknowledged to have more thorough knowledge about medicines compared to physicians. In other countries, for instance in the USA and the UK, pharmacists are already participating in these kind of activities, which has been shown to improve health-related outcomes [31]. It was however surprising that the community pharmacy were disregarded as a place for drug information, and only acknowledged as a place for drug dispensing. This is contradictory to the Norwegian legal framework of the pharmacies, where the role concerning medication information is emphasized [32]. This perception needs further investigation, as this will be crucial for further development of patient-centred community pharmacy services.
Despite a consistent positive attitude to the pharmacist as part of the health-care team, we need to take into account that participants were concerned about how the pharmacist-physician collaboration should function without friction. The fact that pharmacists are not fully acknowledged as part of the interdisciplinary team in Norway today may have contributed to this finding. It will be essential to clarify the clinical pharmacist's role in the healthcare team, allowing patients to know exactly what to expect from the different health-care personnel.
Credibility "Credibility deals with the focus of the research and refers to confidence in how well data and processes of analysis address the intended focus" [22]. In our study, several elements need to be considered: i) The number of informants may not have been sufficient to embrace all aspects of the follow-up program and a larger study may have shown more variation in findings. However, the four main topics were explored and elaborated satisfactory by all participants. The results of a qualitative study cannot be generalized in the same way as in quantitative studies. The study has, however, shown what it may be like to be in the follow-up program-an insight that in itself may enrich our body of knowledge and also initiate new research questions. ii) The interviews focused on four main topics, which is also reflected in the findings above. The narrative approach was important, and a semi-structured interview-guide was supposed to allow the participants to tell their own story in their own words. We wanted to gain knowledge concerning the main topics, but also concerning other relevant aspects not covered by the main topics. We realize that focus on the main topics may have been too strong to allow for the latter to happen. iii) The interviews were performed at the Department of Pharmacy. Dahlberg argues that interviews in the participants' homes is experienced as safer and more Comfortable [33]. Consequently, we might have gained more knowledge if interviews were performed in the participants' home. (iv) Verbatim transcribing of the interviews was done in 'bokmål' , which was neither spoken by the informants nor by the interviewer. This may have introduced misunderstandings. We did try to diminish this by listening to the text several times during transcription. Additionally, quotes have been translated from Norwegian to English, which again may have introduced ambiguity in interpretation. This was sought diminished by verifying translation by several parts. Nevertheless, some degree of interpretation cannot be avoided because qualitative research is a product of reflexivity (that fact that the researcher's pre-understanding and decisions will inevitable have impact upon the meaning and context of the experience under investigation between informants, interviewer and analysing process) [34]. This has to be interpreted by the reader in the light of our descriptions. v) The second analysis was performed by the PI, who was the clinical pharmacist during the follow-up program. Recall bias has been minimized by concealing patient identity and performing the second analysis more than twelve months after the end of the follow-up program. Nevertheless, the analysis may be biased by personal perceptions and negative patient experiences with the follow-up program may be concealed. Because the narratives were analysed twice by different persons and validated by the research group, we have sought to diminish also this bias.

Dependability
Dependability concerns "the degree to which data change over time and alterations made in the researcher's decisions during the analysis process" [22]. Our data comprised four narratives that were collected during a relative short period of time. The time factor is not considered crucial in relation to the content of the interviews. The interviewer may have changed his interviewing technique slightly from interview to interview, which is considered one of the hallmarks of good qualitative methodology; variability rather than standardization, also called flexibility [34]. It is, however, important that flexibility is considered alongside reflexivity [34]. In this case, that the interviewer was an undergraduate pharmacist student, inexperienced in qualitative interviewing and possibly biased by the fact that he thought this program was positive. If the interviewer for instance had a different professional background, had more experience or was negative towards such a program, results might have been different and other aspects of the program may have been revealed.

Transferability
Transferability refers to "the extent to which the findings can be transferred to other settings or groups" [22]. We only included patients with CHD, who were participants of the follow-up program. Our results consequently reflect our new knowledge concerning this particular patient group and this particular follow-up program. However, as CHD is the number one disease worldwide, and also frequently co-morbid to other diseases, for example diabetes, renal failure and chronic obstructive pulmonary disease (COPD), our findings may be applicable also in other patient groups. However, this remains to be explored. It is said that "the most useful indicator of credibility of the findings is when the practitioners themselves and the readers of the theory view the study findings and regard them as meaningful and applicable in terms of their experience" [35].