Methods

Screening and recruitment

Patients were recruited in the Hypertension and Cardiovascular Prevention Unit, Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP), Paris.
Inclusion criteria were to be regularly followed by a physician of the unit, to have at least one chronic pathology among hypertension, hypercholesterolemia and type 2 diabetes, and to not reach the therapeutic objectives despite a drug treatment. Patients under 18 years old, pregnant women and non-French speakers were non-eligible for inclusion.

Study design

This was a single site, single blinded, randomized, controlled, study. Eligible patients were included by the physician at the end of their medical consultation and randomized by the pharmacist with a randomization list kept hidden from the physicians either in the control group or in the intervention group. The intervention group benefited from a pharmaceutical intervention just after the inclusion. Both groups had a follow up consultation three months after the inclusion, as planned in their usual medical care. For ethical reasons, the control group benefited from a pharmaceutical intervention after the follow-up consultation (Figure 1).

Legal aspects

The protocol was approved by an Ethics Committee (Comité de Protection des Personnes d’Île-de-France n°1) in agreement with the European Agency Guidelines for Good Clinical Practice, and declared to the ANSM, the French Medicines Agency (n°2015-A00228-41). Each patient was informed of the purpose of the study, received an information letter and signed a consent form before inclusion.

Data collection and treatments

HbA1c, BP and LDL-c levels were obtained from the physicians at the inclusion and at the follow-up consultation. Information like number of drugs prescribed, other chronic diseases, age and kidney and liver functions were obtained from the patient medical record. The presence of side effects, the adherence score and the information used to estimate the socio-economical level were collected during the inclusion interview. Polypharmacy was defined as a daily intake of five different drugs or more, following previous studies methodology[46,47]. The socio-economical level was estimated based on the education level and the Bachelor’s Degree: 1 for an education level below the high school diploma, 2 for an education level equivalent to the high school diploma and 3 for an education level higher than the high school diploma.

Intervention

The same pharmacist (CD) performed all the pharmaceutical interventions. The intervention consisted in providing patient education on pathology management and advice on how to deal with the pathology on a daily basis. The intervention frame for hypertension was set following general literature recommendations[48], the French Society of Hypertension recommendations for the “information and announce consultation” [49] and the “pharmaceutical interviews in case of high blood pressure” elaborated in partnership with the French Society of Clinical Pharmacy[50]. The hypertension frame was adapted for hypercholesterolemia and type 2 diabetes. The following items were discussed with open questions:
The discussion was an open interaction with the patient and all the topics on which he had questions were addressed. The point of this intervention was to determine the patient’s knowledge and capabilities regarding his pathology in order to focus on his lack.