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 pathology: definition, origins, consequences, follow-up, non-drug
treatment and nutritional-hygienic rules
- Drug mechanisms of action
- Posology and drug intake modalities
- Adherence and behavior in case of missed dose
- Drugs side effects and their handling
- Drug interactions and self-medication
- Medication plan elaboration (if necessary)
- Temporality and chronic aspects
- Patient feelings and perception
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.