NCT02126930

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. 1.. the patient did not go and get his/her treatment at the pharmacy;
  2. 2.. the number of treatment units dispensed by the pharmacy is \< the number of treatment units prescribed;
  3. 3.. the patient stopped taking a treatment before the recommended time, or continued taking a treatment after the recommended time;
  4. 4.. the number of treatment units taken by the patient (self-declaration) is \< or \> to the number of units prescribed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

April 28, 2014

Last Update Submit

April 6, 2016

Conditions

Infection

Keywords

anti-infectious treatmentobservancepharmaceutical consultation

Outcome Measures

Primary Outcomes (1)

  • The presence/absence of treatment non-adherence

    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.

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

Secondary Outcomes (8)

  • 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)

  • +3 more secondary outcomes

Study Arms (2)

Routine care

ACTIVE COMPARATOR

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

Other: Routine care

Pharma consult

EXPERIMENTAL

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

Other: Pharma consult

Interventions

Pharma consultOTHER

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

Pharma consult
Routine careOTHER

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

Routine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Harmonie Faure

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

April 30, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

FR(1)