Study Design
The CPMM Project has been designed as a randomised controlled trial (RCT) with an intervention group and a control group. The control group represents "usual care" versus the structured intervention that will be carried out by the community pharmacist.
Patient Recruitment
The primary subjects for the study are male and female patients, aged 18 years and over, with coronary heart disease (defined as previous myocardial infarction, angina, coronary artery by-pass graft, angioplasty).
Patients suitable for participation will be identified by structured searches in general practice computer systems using READ codes for coronary heart disease and related cardiovascular diagnoses. From the search list, the GP will authorise which patients should be invited to participate in the study after having taken account of the exclusion criteria, which excludes patients who are illiterate, innumerate, suffer from alcohol or drug misuse, are terminally or seriously ill, have severe mental illness, are unable to give informed consent, or in the opinion of the GP are unsuitable to participate.
Eligible patients will be sent a letter of invitation, which will include patient information sheets and consent forms. Patients who respond positively will then be randomised and pharmacists will be informed which patients will form their intervention group and receive core data about the patient that has been extracted from the medical record.
The patients in the intervention group will be invited to make an appointment at their usual pharmacy, thus beginning the process for the medicines management intervention.
Intervention
The community pharmacist will follow a simple structured approach. The intervention will normally take place in the community pharmacy, and participating pharmacies will conform to premises standards, which include a private consultation area. In some cases, a pharmacist might make an intervention on a domiciliary visit.
The initial consultation will be expected to last about 30 minutes, subsequent interviews being about 5-10 minutes. The number of follow-up interviews will be determined by the pharmacist based on the patient’s needs, but it is anticipated that about three further interviews will be required during the 12 month study period.
It is expected that each pharmacist will provide structured interventions to 20 patients during the project, with a total of about 1200 patients being provided a service as the intervention group.
In addition to the structured intervention, there will be opportunistic input from the pharmacist at the point of dispensing. The following issues will be covered:
- Appropriateness of therapy
- Compliance and concordance
- Lifestyle issues
- Social and support issues
To find out more about the study design download the Research Protocol (PDF).
