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

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

Detailed Description
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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)

Official Title
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Impact of a Pharmaceutical Consultation at Hospital Discharge on Adherence to Anti-infective Treatment After Returning Home

Conditions
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Infection

Intervention / Treatment
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* Other: Pharma consult
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine care<br>The patients in this receive routine care. Intervention: Routine care | Other: Routine care<br>* Patients randomized to this arm will receive care in the habitual manner.<br>|
| Experimental: Pharma consult<br>The patients in this arm will have a pharmaceutical consult upon hospital discharge. Intervention: Pharma consult | Other: Pharma consult<br>* Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence/absence of treatment non-adherence | As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria is true: . the patient did not go and get his/her treatment at the pharmacy; . the number of treatment units dispensed by the pharmacy is < the number of treatment units prescribed; . the patient stopped taking a treatment before the recommended time, or continued taking a treatment after the recommended time; . the number of treatment units taken by the patient (self-declaration) is < or > to the number of units prescribed. | 1 week after end of treatment (expected max of 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery of anti-infectious therapy by the pharmacy (yes/no) |  | 1 week after end of treatment (expected max of 4 weeks) | 
| 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) | 
| 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) | 
| Quiz on anti-infective therapy comprehension |  | Day 0 (hospital discharge) | 
| Socio-demographic characteristics |  | Day 0 (hospital discharge) | 
| Test for measuring overall compliance (MAQ) |  | Day 0 (hospital discharge) | 
| Satisfaction Questionnaire concerning pharmaceutical consultation |  | Day 0 (hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-infectious treatment, observance, pharmaceutical consultation