Clinical trial NCT02126930: Pharmaceutical Consultation at Hospital Discharge and Adherence to Anti-infective Treatment
Official title: Impact of a Pharmaceutical Consultation at Hospital Discharge on Adherence to Anti-infective Treatment After Returning Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: anti-infectious treatment
observance
pharmaceutical consultation
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to evaluate the impact of a pharmaceutical consultation at the time of hospital discharge on the adherence of patients ; non-adherence is determined by the following criteria:

As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria is true:

1. . the patient did not go and get his/her treatment at the pharmacy;
2. . the number of treatment units dispensed by the pharmacy is \< the number of treatment units prescribed;
3. . the patient stopped taking a treatment before the recommended time, or continued taking a treatment after the recommended time;
4. . the number of treatment units taken by the patient (self-declaration) is \< or \> to the number of units prescribed.

Detailed description: The secondary objectives of this study are :

A- To assess the percentage of patients who obtained their anti- infective pharmaceuticals

B- To evaluate the ratio of the number of units of anti- infective drugs dispensed by the pharmacy over the number of units of anti- infective drugs prescribed

C- To determine the ratio of the number of premature discontinuations of anti -infective treatments over the number of lines of anti -infective treatments prescribed

D- Evaluate the ratio of the number of units actually taken by the patient (based on a self-declaration) over the number of units of anti- infective drugs prescribed

E- To measure the comprehension concerning anti- infective treatments after returning home (based on a quiz)

F- To determine the risk factors for non- adherence to anti- infective therapy based on the characteristics of the study population

G- Assess patient satisfaction concerning a pharmaceutical consultation at hospital discharge (questionnaire)

H- Assess the impact of a pharmaceutical consultation on primary non-adherence (criteria 1 and 2) and secondary non- adherence (criteria 3 and 4)

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is hospitalized in the Infectious and Tropical Diseases department of the Nîmes University Hospital, and is scheduled for hospital discharge with one or more pharmaceutical prescriptions for anti-infectious treatments

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient resides in a care establishment, or has home medical/nursing service
* The patient is suffering from chronic infection (\>4 weeks of treatment required)
* The patient is suffering from handicapping deafness, dementia, or does not have a telephone
* Intravenous, intramuscular or subcutaneous anti-infectious treatments are prescribed
* Prescription of antiretroviral treatments

Primary outcomes:
measure: The presence/absence of treatment non-adherence
timeFrame: 1 week after end of treatment (expected max of 4 weeks)
Secondary outcomes:
measure: Delivery of anti-infectious therapy by the pharmacy (yes/no)
timeFrame: 1 week after end of treatment (expected max of 4 weeks)
measure: Number of anti-infectious drug units dispensed by the pharmacy / number of anti-infections drug units prescribed
timeFrame: 1 week after end of treatment (expected max of 4 weeks)
measure: Number of premature discontinuations of anti-infective therapies / the prescribed number of anti-infective treatments
timeFrame: 1 week after end of treatment (expected max of 4 weeks)
measure: Number of anti-infectious drug units taken by the patient (self-declaration) / number of anti-infections drug units prescribed
timeFrame: 1 week after end of treatment (expected max of 4 weeks)
measure: Quiz on anti-infective therapy comprehension
timeFrame: Day 0 (hospital discharge)
measure: Socio-demographic characteristics
timeFrame: Day 0 (hospital discharge)
measure: Test for measuring overall compliance (MAQ)
timeFrame: Day 0 (hospital discharge)
measure: Satisfaction Questionnaire concerning pharmaceutical consultation
timeFrame: Day 0 (hospital discharge)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Harmonie Faure
role: STUDY_DIRECTOR
References: