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NCT Number: NCT02126930

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

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.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharma consult

Other

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

Routine care

Other

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

Primary outcomes

  1. 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:

    • . 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.

Secondary outcomes

  1. Delivery of anti-infectious therapy by the pharmacy (yes/no)

    Time frame: 1 week after end of treatment (expected max of 4 weeks)

  2. Number of anti-infectious drug units dispensed by the pharmacy / number of anti-infections drug units prescribed

    Time frame: 1 week after end of treatment (expected max of 4 weeks)

  3. Number of premature discontinuations of anti-infective therapies / the prescribed number of anti-infective treatments

    Time frame: 1 week after end of treatment (expected max of 4 weeks)

  4. Number of anti-infectious drug units taken by the patient (self-declaration) / number of anti-infections drug units prescribed

    Time frame: 1 week after end of treatment (expected max of 4 weeks)

  5. Quiz on anti-infective therapy comprehension

    Time frame: Day 0 (hospital discharge)

  6. Socio-demographic characteristics

    Time frame: Day 0 (hospital discharge)

  7. Test for measuring overall compliance (MAQ)

    Time frame: Day 0 (hospital discharge)

  8. Satisfaction Questionnaire concerning pharmaceutical consultation

    Time frame: Day 0 (hospital discharge)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: CPS-INFECTIO

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2014
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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