InfectionCPS-INFECTIONCT02126930
Pharmaceutical Consultation at Hospital Discharge and Adherence to Anti-infective Treatment
A study testing Pharma consult and Routine care in people with Infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Pharma consult and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- . 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.
Read the 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)
- Conditions
- Infection
- Being tested
- Pharma consult, Routine care
- Keywords
- anti-infectious treatment, observance, pharmaceutical consultation
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharma consultOther
Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.
Routine careOther
Patients randomized to this arm will receive care in the habitual manner.
| Study group | Role | What they receive |
|---|---|---|
| Routine care | Active comparator | The patients in this receive routine care.
Intervention: Routine care Receives: Other: Routine care |
| Pharma consult | Experimental | The patients in this arm will have a pharmaceutical consult upon hospital discharge.
Intervention: Pharma consult Receives: Other: Pharma consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after end of treatment (expected max of 4 weeks)
Secondary outcomes (8)
Delivery of anti-infectious therapy by the pharmacy (yes/no)
Measured: 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
Measured: 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
Measured: 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
Measured: 1 week after end of treatment (expected max of 4 weeks)
Quiz on anti-infective therapy comprehension
Measured: Day 0 (hospital discharge)
Socio-demographic characteristics
Measured: Day 0 (hospital discharge)
Test for measuring overall compliance (MAQ)
Measured: Day 0 (hospital discharge)
Satisfaction Questionnaire concerning pharmaceutical consultation
Measured: Day 0 (hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harmonie Faure, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126930
- Sponsor's protocol ID
- LOCAL/2014/HF-01
- Other IDs
- 2014-A00335-42, 2014-A00944-43, LOCAL/2014/AS-01
- Acronym
- CPS-INFECTIO
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2014
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmaceutical Consultation at Hospital Discharge on Adherence to Anti-infective Treatment After Returning Home
- ClinicalTrials.gov ID
- NCT02126930
- Acronym / sponsor ID
- CPS-INFECTIO / LOCAL/2014/HF-01
- Conditions
- Infection
- Keywords
- anti-infectious treatment, observance, pharmaceutical consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- . 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | Active comparator | Other: Routine careThe patients in this receive routine care. Intervention: Routine care |
| Pharma consult | Experimental | Other: Pharma consultThe patients in this arm will have a pharmaceutical consult upon hospital discharge. Intervention: Pharma consult |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharma consultUpon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment. | Other | Pharma consult |
| Routine carePatients randomized to this arm will receive care in the habitual manner. | Other | Routine care |
Primary outcome
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: 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.
8 secondary outcomes
Delivery of anti-infectious therapy by the pharmacy (yes/no)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week after end of treatment (expected max of 4 weeks)
Quiz on anti-infective therapy comprehension
Time frame: Day 0 (hospital discharge)
Socio-demographic characteristics
Time frame: Day 0 (hospital discharge)
Test for measuring overall compliance (MAQ)
Time frame: Day 0 (hospital discharge)
Satisfaction Questionnaire concerning pharmaceutical consultation
Time frame: Day 0 (hospital discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harmonie Faure study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharma consult and Routine care in people with Infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence/absence of treatment non-adherence (time frame: 1 week after end of treatment (expected max of 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.