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Clinical Trials/NCT02126930
NCT02126930
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country174 target enrollmentNovember 2014
ConditionsInfection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
174
Locations
1
Primary Endpoint
The presence/absence of treatment non-adherence
Status
Completed
Last Updated
10 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The presence/absence of treatment non-adherence

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

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