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

Abstract

The prevalence of elderly patients with chronic illnesses, associated polypharmacy and a high risk of functional and cognitive impairment has increased in recent</p><p>years. The care of Complex Chronic Patients (CCP) therefore represents a challenge for health systems in developed countries around the world. This paper presents</p><p>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</p><p>the organisational methods proposed for the PCAF programme.</p><p>This is a multicentre experimental study. The setting will be primary health care and community pharmacies in the so-called ‘autonomous community’ of Catalonia</p><p>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</p><p>distributed in two strata depending on whether they will be considered likely to receive the arranged medicinal treatment as Monitored Dosage System according</p><p>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</p><p>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</p><p>Green Test and the billing/prescription ratio.