Pharmaceutical Consultation at Hospital Discharge and Adherence to Anti-infective Treatment (CPS-INFECTIO)

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

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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Other: Routine care; Other: Pharma consult

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 Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Routine care; The patients in this receive routine care. Intervention: Routine care	Other: Routine care; Patients randomized to this arm will receive care in the habitual manner.
EXPERIMENTAL: Pharma consult; The patients in this arm will have a pharmaceutical consult upon hospital discharge. Intervention: Pharma consult	Other: Pharma consult; Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Harmonie Faure, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (ESTIMATE): April 30, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: observance; pharmaceutical consultation; anti-infectious treatment
• Other Study ID Numbers: LOCAL/2014/HF-01; 2014-A00335-42 (OTHER: RCB number); 2014-A00944-43 (OTHER: RCB number); LOCAL/2014/AS-01 (OTHER: obsolete sponsor number)