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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02126930
Acronym
CPS-INFECTIO
Enrollment
174
Registered
2014-04-30
Start date
2014-11-30
Completion date
2016-03-31
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

anti-infectious treatment, observance, pharmaceutical consultation

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)

Interventions

OTHERPharma consult

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

OTHERRoutine care

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The presence/absence of treatment non-adherence1 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

MeasureTime frame
Number of anti-infectious drug units dispensed by the pharmacy / number of anti-infections drug units prescribed1 week after end of treatment (expected max of 4 weeks)
Number of premature discontinuations of anti-infective therapies / the prescribed number of anti-infective treatments1 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 prescribed1 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)
Socio-demographic characteristicsDay 0 (hospital discharge)
Test for measuring overall compliance (MAQ)Day 0 (hospital discharge)
Satisfaction Questionnaire concerning pharmaceutical consultationDay 0 (hospital discharge)
Quiz on anti-infective therapy comprehensionDay 0 (hospital discharge)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026