Family Practice Advance Access originally published online on January 31, 2007
Family Practice 2007 24(2):189-200; doi:10.1093/fampra/cml075
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The MEDMAN study: a randomized controlled trial of community pharmacy-led medicines management for patients with coronary heart disease
Correspondence to Christine Bond, Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen AB25 2AY, UK; Email: c.m.bond{at}abdn.ac.uk
Received 2 March 2006; Revised 7 July 2006; Accepted 6 December 2006.
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Abstract |
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Background. There have been recent moves to extend the role of the community pharmacist to include medicine management.
Methods. A randomized controlled trial was conducted in nine sites in England. Patients with coronary heart disease were identified from general practice computer systems, recruited and randomized (2:1) to intervention or control. The 12-month intervention comprised an initial consultation with a community pharmacist to review appropriateness of therapy, compliance, lifestyle, social and support issues. Control patients received standard care. The primary outcome measures were appropriate treatment [derived from the National Service Framework (NSF)], health status (SF-36, EQ-5D) and an economic evaluation. Secondary outcome measures were patient risk of cardiovascular death and satisfaction.
Results. The study involved 1493 patients (980 intervention and 513 control), 62 pharmacists and 164 GPs. No statistically significant differences between intervention and control groups were shown at follow-up for any of the primary outcome measures such as numbers on aspirin or lifestyle measures. There were few differences in quality of life (SF-36) between the intervention and control groups at baseline or follow-up or with overall EQ-5D score over time. The total National Health Service cost increased between baseline and at 12 months in both groups but to a greater extent in the intervention group. Significant improvements were found in the satisfaction score for patients' most recent pharmacy visit for prescription medicines among the intervention group, compared with control group. Self-reported compliance was good for both groups at baseline and no significant differences were shown at follow-up.
Conclusion. There was no change in the proportion of patients receiving appropriate medication as defined by the NSF. The pharmacist-led service was more expensive than standard care.
Keywords. Clinical outcomes, community pharmacy, coronary heart disease, RCT.
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Introduction |
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Coronary heart disease (CHD) is a leading cause of morbidity and mortality in industrialized countries, with the UK having some of the highest age standardized mortality rates.1 Individuals with CHD are at high risk of further coronary events, although this risk can be significantly reduced.2–5 Organized provision of treatment in general practice has important short- and long-term benefits6,7 but current care in general practice remains suboptimal.8
The role of community pharmacists within the UK is changing to include the management of patients' medicines.9 A systematic review10 of community pharmacist interventions in CHD provides some evidence of benefits, including improvements in blood pressure,11,12 cholesterol,13 anticoagulant control14and smoking cessation rates.15–17 However, few large randomized controlled trials (RCTs) have been conducted of comprehensive, community pharmacy-led medicines management (MEDMAN) services. This paper presents the results of a RCT to test the hypothesis that a comprehensive MEDMAN service would (i) increase the proportion of patients receiving treatment according to the National Service Framework18 (NSF) in England and Wales; (ii) improve overall patient health status; and (iii) be cost effective.
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Methods |
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Study design
An RCT comparing patients with CHD, who received the community pharmacy-based medicines management service intervention, with control CHD patients, who received usual general practice-based care, was conducted between November 2002 and May 2004.
Participants
Nine study sites were purposively selected from a list of 33 volunteer primary care organizations in England, provided by the Pharmaceutical Services Negotiating Committee (PSNC), purposively selected on the basis of local knowledge to include a range of population, general practice and community pharmacy characteristics. Patients registered with the general practices, aged over 17 years, and with CHD (previous myocardial infarction, angina, coronary artery bypass graft and/or angioplasty) were eligible. Exclusion criteria (illiterate/innumerate, history of alcohol/drug misuse, terminal/serious illness, severe mental illness and unable to provide informed consent or otherwise unsuitable for the trial) were applied by the GP.
Recruitment of participants
The patient recruitment and intervention process are shown in Figure 1. Practices generated a list of all patients with CHD. GPs screened the list and sent invitation packs (invitation letter, trial information sheet and consent form) to eligible patients. Signed consent forms were returned directly to the researchers, and included the name of the preferred community pharmacy provider. Patients were randomized in a ratio of 2:1, intervention to control group. This was done independently of the research team using a password protected computer programme in permuted blocks stratified by practice. Community pharmacists were given an indicative allocation of 20 patients. If more than 20 patients chose one pharmacy, the pharmacist could choose to go ‘over quota’, or refuse the patient who was asked to choose another pharmacy, or was excluded (designated over quota in Fig. 1).
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Audit clerks, blind to patient randomization status, extracted and recorded baseline data from general practice records [confirmation of inclusion criteria, relevant medical history (e.g. significant diagnoses and known allergies), clinical indicators (e.g. last blood pressure, lipid measurement, pulse rate, blood glucose, weight and height), current medication, documented use of over-the-counter (OTC) medicines and use of health service resources in the previous 12 months]. All forms were returned to the research team who forwarded copies of intervention patients' forms to their nominated pharmacist.
Patients' self-reported baseline data were collected by postal questionnaire (health status; compliance with treatment; experience of, and satisfaction with, community pharmacy services and the cost of accessing health care services).
Intervention patients received a study registration card and a letter asking them to visit their nominated pharmacy to initiate the service. Pharmacists were instructed to contact the patients if they were not contacted spontaneously. Patients in the control group received usual care from their GP and community pharmacist.
The intervention
The medicines management service was delivered from community pharmacy premises, by community pharmacists who had received training designed and delivered by the Centre for Pharmacy Post-Graduate Education. The intervention comprised an initial consultation informed by the extracted medical data supplied by the researchers. Further consultations were provided according to pharmacist-determined patient need. Consultations included assessments of the following: therapy, medication compliance, lifestyle (e.g. smoking cessation, exercise and diet) and social support (e.g. difficulties in collecting prescriptions and opening bottles). Recommendations were recorded on a referral form which was sent to the GP, who returned annotated copies to the pharmacists. Only pharmacies with private consultation areas were eligible to participate. Further information about the consultations is available in the final report to the funding body (available from the authors).
Follow-up
The follow-up period was 12 months from the date of the first pharmacy appointment, or estimated equivalent for controls. Follow-up data were collected by audit clerks and postal questionnaire as at baseline. Intervention patients were also asked about their experience of the medicine management service.
Outcome measures
Primary outcomes were as follows: proportion of patients receiving secondary prevention treatment for CHD in accordance with the NSF (2000) (Box 1); a cumulative score summarizing ‘appropriate treatment’ and advice (Box 2); health status (SF-3619 EuroQOL20); and a health economic analysis. National Health Service (NHS) resource use was based on information extracted from general practice-held records at baseline and follow-up. The total NHS cost was, for intervention patients only, the sum of the costs of delivering the intervention (training and intervention visits) and, for both intervention and control patients, NHS treatment costs (including cost of medicines, hospital and other health consultations). Training costs included direct (e.g. venue costs) and indirect (e.g. attendance fees) costs. Secondary outcomes were as follows: 5-year risk of cardiovascular death based on an existing score modified to allow for the absence of data on history of stroke and creatinine concentration,21,22 patient satisfaction and compliance with treatment.
BOX 1 Operationalization of NSF guideline targets
a LVD is not recorded routinely in general practice. Therefore, LVH and/or cardiac failure were used as a proxy measure for LVD.
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15 minutes duration; and moderate or vigorous intensity
25 kg/m2BOX 2 Appropriate treatment score
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The final satisfaction score included experience of and satisfaction with the community pharmacy service and was assessed by measuring response to 15 positive and negative statements regarding their most recent pharmacy visit. Statements were derived from a review of the relevant patient satisfaction literature.23 Possible responses ranged from 5 to 1 for strongly agree to strongly disagree for positive statements and from 1 to 5 for negative statements, summated to give an overall satisfaction score (range 15–75). Similarly, 12 statements about medicine taking were included and summated to derive a self-reported compliance score (range 12–60).
Blinding
Patients could not be blind to trial intervention because of its nature. Community pharmacists were not informed which control patients had nominated their pharmacy. Audit clerks performing data extraction were blind to the randomization status of participants, as were the researchers conducting the statistical analyses.
Sample size
The power calculation was based on the NSF recommendations (Box 1) of aspirin-related management for all patients with CHD. From a local audit of 71 GP practices (Philip Hannaford, personal communication.), 80% of patients were estimated to be on aspirin. For a standard RCT using 2:1 randomization, a total of 1920 evaluable patients (1280 intervention and 640 control) were required to detect a change from 80% to 86% for the percentage of patients receiving aspirin, with 90% power and a 5% significance level.
Statistical methods
Data were analysed using SPSSv11.5 and STATA v8. Descriptive statistics are presented as means (SD) for normally distributed continuous data, medians [interquartile range (IQR)] for skewed continuous data and percentages (n) for categorical data. The main analysis was conducted on an intention-to-treat basis. Regression modelling was used to estimate the effect [odds ratios (ORs) or adjusted mean differences and their corresponding 95% CI] of the intervention on primary and secondary outcomes, while adjusting for baseline differences between groups and clustering by practice, pharmacy and area. Patients with missing data at either time point were excluded from these analyses. Additional analysis using the chi-square test was also conducted to compare between groups the extent of patients' agreement with a series of statements about their experiences in the community pharmacy. Due to the large number of statistical tests conducted for this, a P-value of <0.01 was used to denote statistical significance.
Potential selection bias resulting from loss to follow-up or missing data was tested, and adjusted for, using the Heckman selection correction.24 Where evidence of selection bias was found, the unbiased effect of the intervention (i.e. with the Heckman selection correction applied) is reported.
Costs were reported using the median and IQR for skewed data. Comparisons between groups were conducted using the Mann–Whitney test for independent groups and the Wilcoxon signed ranks test for related groups.
Data management
Data were entered into an Access database with 10% checked for accuracy. In this paper, we only report percentages for participants with a full set of available data at each time point.
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Results |
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Participants
In total, 1493 patients were randomized (980 intervention and 513 control). Data extraction was completed at baseline for 1441 patients and for 1334 patients at follow-up (Fig. 2). No substantial differences in the baseline characteristics of the trial groups (Table 1) were found. A total of 70 pharmacies (102 pharmacists) and 48 practices (208 GPs) were recruited, of which 50 (62 pharmacists) and 39 (164 GPs) completed.
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Primary outcomes
No statistically significant differences were found for any of the (adjusted) main outcome measures between the two groups at follow-up (Tables 2–4).
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There were no significant differences in lifestyle factors between the groups (Table 2) at baseline or at follow-up. A higher percentage of data regarding lifestyle was available at follow-up in both groups (because of better supply of information at follow-up by patients) compared with baseline. The global score for appropriateness of treatment was not significantly different between groups.
There were no significant differences between groups in individual SF-36 domains or in overall EQ-5D score (Table 4).
The economic evaluation was a cost-minimization analysis, in which all relevant P-values are from a multiple regression analysis to examine differences in costs at follow-up between the intervention and the control group, adjusted for differences in costs at baseline and clustering within pharmacy, GP practice and area (where necessary).33 The difference at follow-up in total NHS-related cost was statistically significant (Table 5), due to the cost of providing pharmacist training.
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Secondary outcomes
Five-year risk of cardiovascular death.. The 5-year risk of cardiovascular death score at baseline could be calculated for 964 (66.5%) patients (Fig. 3). Apparent benefits in the intervention group at follow-up did not reach statistical significance.
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Patients' perspectives: satisfaction, experience and attitudes.. In the intervention group, statistically significant improvements (P < 0.01) were found in the single computed satisfaction score for patients' most recent pharmacy visit for prescription medicines compared with control patients (Table 4).
Patient compliance.. At baseline, the median score for compliance for the intervention and control groups was high at 59 (IQR 56–60) and was little changed at follow-up (Table 3).
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Discussion |
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This MEDMAN intervention for patients with CHD did not demonstrate any significant change in NSF-recommended treatment for the secondary prevention of CHD, or future risk of cardiovascular death. The cost of the intervention was more than that of standard care. Patient satisfaction in the intervention group increased significantly compared with controls.
Strengths and limitations
The study had a number of important strengths compared with many previous pharmacy intervention studies. It is the largest RCT in the British community pharmacy setting using established validated, primary outcomes. Data extraction and analysis were blind, and high follow-up rates were achieved. Limitations included the following: choice of condition (most patients at baseline were already receiving optimal treatment for aspirin-related outcomes), lack of information on the extent to which pharmacist recommendations were implemented by GPs, potential bias from the use of self-reported questionnaires and levels of missing data for some lifestyle components [e.g. body mass index (BMI) at follow-up]. Equal weighting of individual components of the appropriateness of treatment score did not necessarily reflect the contribution of these factors to CHD risk. In addition, the self-selection of the primary care organizations and practices within them and the low proportion of eligible patients consenting might have limited the trial's generalizability. For example, patients appeared to have a high compliance with medication taking, reducing the potential for improvements in care. Finally, target recruitment numbers were not achieved. A post hoc power calculation indicates that the study had a resulting power of 74% to detect the 6% difference in the percentage of patients receiving aspirin. The underpowering of the study may have increased the chance of a Type II error. The original sample size calculation was based on absolute risks (benefits) and this methodology is conventionally used in RCTs. However, in the analyses, as is also standard, the relative risk was used to assess the strength of association because the amount by which an intervention multiplies the risk of an event is interpretable regardless of the size of the risk.
Primary outcomes
The lack of observed change in this study, in the main outcome measures of appropriateness, may be explained by the high proportion of patients already receiving NSF-recommended treatment. This ceiling effect might have been avoided if pharmacists had identified patients whose treatment was not in line with the agreed guidelines and agreed individual patient goals with the responsible GP, as has been done in Australia.2 GPs might have optimized patient care before the study commenced, possibly influenced by the imminent introduction of the quality and outcomes framework of the new General Medical Services contract, in which CHD outcomes are targets.28 Differences in time frames and practices mean that direct comparisons of the proportions achieving targets would be inappropriate. Some baseline values such as aspirin were higher than previously reported6 and studies have shown that there have been increases in their use recently.8 Failure to achieve improvements in the main outcomes has been shown previously with MEDMAN studies25 although others have demonstrated improvements in individual components of medicines management.26,27
Secondary outcomes
Despite high baseline satisfaction scores in both groups, there was a small but significant increase in the intervention group score at follow-up compared to the controls reflecting previous studies assessing satisfaction with the extended role for community pharmacists.30–32 A full qualitative evaluation of the service is reported elsewhere.33
Policy implications
New services within health care can be difficult to implement, particularly, when they occur across traditional professional boundaries. Perceived ‘boundary encroachment’ may be met either by ‘accommodation’ or by attempts at ‘exclusion’.34 A study of collaboration between community pharmacists and family practitioners35 demonstrated a need for clarification of the community pharmacist and physician roles. The extent to which GPs and community pharmacists worked together in this study is unclear. The importance of a systematic approach when changing professional practice, with careful planning, resourcing, implementation and monitoring has been emphasized.36 All of these may not have been sufficiently addressed in the current study.
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Conclusion |
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This community pharmacist-led intervention did not significantly improve NSF-defined management of CHD.
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Declaration |
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Funding: This trial was funded by the Department of Health for England and Wales, though managed by a collaboration of the National Pharmaceutical Association, the Royal Pharmaceutical Society of Great Britain, the Company Chemist Association and the Co-operative Pharmacy Technical Panel, led by the PSNC. The researchers had no communication with the Department of Health. The managing collaboration had no contribution to the study design; the collection, analysis and interpretation of data; the writing of the report; and the decision to submit the paper for publication. The evaluation team provided feedback to the managing collaboration on patient recruitment and GP and Community Pharmacist participation rates. No information was provided on the study outcomes until all analyses were completed. The views expressed in this paper are those of the authors and may not reflect those of the funding organization or the managing collaboration.
Ethical approval: Ethical approval was obtained from Multicentre Research Ethics Committee (MREC) for Scotland in December 2001 with subsequent local approval granted from all relevant Local Research Ethics Committees by June 2002. MREC reference number: MREC/01/0/95. National Research Register Publication ID: N0572099159.
Conflicts of interest: There were no conflicts of interest. The corresponding author (CB) is the guarantor for the paper and had full access to all the data in the study and final responsibility for the decision to submit for publication. All authors declare that the answer to your question on your competing interest form bmj.com/cgi/content/full/317/7154/291/DC1 is all No and therefore have nothing to declare.
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Acknowledgments |
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This evaluation was led by the University of Aberdeen (CB, PH, MJ, AL, AS, MT and MW) in collaboration with the Universities of Nottingham (CA, AA and PB) and Keele (AB) and the College of Pharmacy Practice (JK). We thank the patients and health care professionals who took part in the study. We also thank PSNC and all the local project and local research co-ordinators who helped with the delivery of the service. We also thank the secretarial staff (Helen Robertson, Anne McAteer, Aileen Thompson and Margaret Ross) who helped with the project.
Contributors: CB was the principal investigator and guarantor for the report. She contributed to the conception and design of the study, the establishment of the team, all aspects of study management, planning of the analysis, interpretation of the results, drafting and revision of this paper. Elizabeth Dinnie contributed to the development of data collection tools and the day to day running of the study. PH contributed to study design, all aspects of study management, planning of the analysis, interpretation of the results, and drafting and revision of this paper. MJ was the trial co-ordinator for the main phase of the study and was responsible for the general management of the study and data collection. She contributed to the revisions to the study protocol for the main phase, planning the analysis and interpretation of the results. She conducted the statistical analysis of the pharmacist training data. She had a major responsibility for the drafting, formatting and finalizing the paper. AL was involved in the planning of all statistical analysis, in the development of methods of quality control of the data and in the drafting of the final report and this paper. Gladys McPherson contributed to methods of data storage and capture and to the establishment of randomization procedures. AS contributed to study design, some aspects of study management, some aspects of data analysis, interpretation of results and drafting the paper. He also conducted all statistical analyses for the main outcomes and supervized the economic analyses. Elizabeth Shirran was the trial co-ordinator for the pilot phase of the study, contributing to the general management of the study and data collection. MT contributed to data collection, analysis of patient and professional questionnaire data, analysis of patient treatment outcomes, economic analysis and drafting of this paper. MW contributed to the conception and design of the study and all aspects of study management, planning the analysis, interpretation of results and drafting, revision and formatting the paper. AB contributed to study design, some aspects of study management and data collection, analysis of patient interviews and interpretation of patient feedback data. She was also involved in the overall interpretation of the results and drafting of the paper. Helen Hooper was involved in the development of the pilot questionnaires. Duncan Short conducted patient qualitative data collection and analysis. CA contributed to the study design, some aspects of study management, some aspects of interpretation of the results and drafting this paper. AA contributed to study design, aspects of study management, interpretation of results, data collection for the GP interviews and Pharmacist recommendation data and drafting the paper. PB contributed to some of the revisions to the study design, some aspects of study management, data collection for the professional interviews and some aspects of interpretation of results and the drafting of the paper. Steve Chapman contributed to the design of the study. Stacey Sadler conducted professional qualitative data collection and analysis and contributed to the drafting of the paper. JK contributed to the study design, development of pharmacist questionnaires, aspects of study management and drafting the paper. She was responsible for the design and conduct of analysis of the community pharmacist recommendation data.
Steering Committee: CB, PH, AS, MW, AB, CA, AA, PB and JK.
Writing Committee: Mariesha Jaffray, Research Fellow, Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY, UK; Christine Bond, Professor of Primary Care (Pharmacy), Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY UK; Margaret Watson, Research Fellow, Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY, UK; Philip Hannaford, Grampain Health Board Chair of Primary Care, Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY, UK; Michela Tinelli, Research Assistant, Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY, UK; Anthony Scott, Professorial Fellow, Melbourne Institute of Applied Economic and Social Resarch, The University of Melbourne, VIC 3010, Australia [Previously (at time of study) Reader in Health Economics, Health Economics Research Unit, University of Aberdeen]; Amanda Lee, Reader in Statistics, Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY, UK; Alison Blenkinsopp, Professor of the Practice of Pharmacy, Department of Medicines Management, Keele University, Keele, Staffs ST5 5BG, UK; Claire Anderson, Professor of the Social Pharmacy, Centre for Pharmacy, Health and Society School of Pharmacy, University of Nottingham, Nottingham NG7 2RD, UK; Anthony Avery, Professor of Primary Health Care, Head of Division of Primary Care, School of Community Health Sciences, The Medical School, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Paul Bissell, Section of Public Health, ScHARR, University of Sheffield, Sheffield S1 HDA, UK [Previously (at time of study) Lecturer in Social Pharmacy Practice, Centre for Pharmacy, Health and Society, University Park, Universtiy of Nottingham, NG7 2RD, UK]; Janet Krska, Professor of Pharmacy Practice, School of Pharmacy and Chemistry, Liverpool John Moores University, Liverpool L3 3AF, UK [Previously (at time of study) Chair, Research Committee College of Pharmacy Practice, Coventry].
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Notes |
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The Community Pharmacy Medicines Management Project Evaluation Team. The MEDMAN study: a randomized controlled trial of community pharmacy-led medicines management for patients with coronary heart disease. Family Practice 2007; 24: 189–200.
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