A study protocol for an experimental study for a pharmaceutical care programme to improve chronic complex disease management: PCAF programme

The prevalence of elderly patients with chronic illnesses, associated polypharmacy and a high risk of functional and cognitive impairment has increased in recent years. The care of Complex Chronic Patients (CCP) therefore represents a challenge for health systems in developed countries around the world. This paper presents a study protocol that will explore the effects of an intervention within a pharmaceutical care programme (PCAF) on optimising CCP care and on the suitability of the organisational methods proposed for the PCAF programme.

This is a multicentre experimental study. The setting will be primary health care and community pharmacies in the so-called ‘autonomous community’ of Catalonia in Spain. The participants will be CPP attended to Primary Healthcare Centres with the CCP code in their electronic medical record. The included CCP will be distributed in two strata depending on whether they will be considered likely to receive the arranged medicinal treatment as Monitored Dosage System according to benefits based on criteria or not. They will then be assigned by random stratified sampling at a ratio of 1:1 to the control or intervention groups. A sample size of 860 patients is estimated. Patients will undergo 12 months follow-up. The primary outcome of this study will be the medication adherence measured by the Morisky Green Test and the billing/prescription ratio.