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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Infection

Treatments: Other: Pharma consult; Other: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT02126930

LOCAL/2014/HF-01

2014-A00944-43 (Other Identifier)

LOCAL/2014/AS-01 (Other Identifier)

2014-A00335-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

174 participants in 2 patient groups

Routine care

Active Comparator group

Description:

The patients in this receive routine care. Intervention: Routine care

Treatment:

Other: Routine care

Pharma consult

Experimental group

Description:

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

Treatment:

Other: Pharma consult