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

Infection Clinical Trial

— CPS-INFECTIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126930
• Other study ID #: LOCAL/2014/HF-01
• Secondary ID: 2014-A00335-4220
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: April 6, 2016
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• Pharma consult
Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.
• Routine care
Patients randomized to this arm will receive care in the habitual manner.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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