Pharmaceutical Consultation at Hospital Discharge and Adherence to Anti-infective Treatment

Not Applicable

Completed

• Conditions: Infection

• Registration Number: NCT02126930
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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)

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2014-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The presence/absence of treatment non-adherence	1 week after end of treatment (expected max of 4 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Test for measuring overall compliance (MAQ)	Day 0 (hospital discharge)
Satisfaction Questionnaire concerning pharmaceutical consultation	Day 0 (hospital discharge)
Number of anti-infectious drug units dispensed by the pharmacy / number of anti-infections drug units prescribed	1 week after end of treatment (expected max of 4 weeks)
Socio-demographic characteristics	Day 0 (hospital discharge)
Number of premature discontinuations of anti-infective therapies / the prescribed number of anti-infective treatments	1 week after end of treatment (expected max of 4 weeks)
Number of anti-infectious drug units taken by the patient (self-declaration) / number of anti-infections drug units prescribed	1 week after end of treatment (expected max of 4 weeks)
Delivery of anti-infectious therapy by the pharmacy (yes/no)	1 week after end of treatment (expected max of 4 weeks)
Quiz on anti-infective therapy comprehension	Day 0 (hospital discharge)

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France