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

NCT ID: NCT02126930

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

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:

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

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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)

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine care

The patients in this receive routine care.

Intervention: Routine care

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

Patients randomized to this arm will receive care in the habitual manner.

Pharma consult

The patients in this arm will have a pharmaceutical consult upon hospital discharge.

Intervention: Pharma consult

Group Type EXPERIMENTAL

Pharma consult

Intervention Type OTHER

Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.

Interventions

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Pharma consult

Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.

Intervention Type OTHER

Routine care

Patients randomized to this arm will receive care in the habitual manner.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harmonie Faure

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00335-42

Identifier Type: OTHER

Identifier Source: secondary_id

2014-A00944-43

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/AS-01

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/HF-01

Identifier Type: -

Identifier Source: org_study_id

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