Medication ReconciliationCONCIVILLENCT03029052
Medication Reconciliation at Discharge: Impact on Patient's Care
A study testing Reconciliation in people with Medication Reconciliation, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Medication Reconciliation
- What is being tested?
- Reconciliation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2017to 2 Jul 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old
- hospitalized in infectious disease department
- with a chronic disease and a current medical prescription including at least three drugs
- discharged home or nursing home
- not opposed to the study
Who cannot join
- foreigners, patients under legal guardianship
- advanced dementia (MMS<20) or phone tracking impossible
- primary care physician opposed to answer questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Pilot Study in an Infectious Disease Department Assessing the Impact of Medication Reconciliation at Discharge Associated With a Patient's Counseling Session, Both Provided by a Pharmacist, on Patient's Care After Discharge
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). The investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge.
Read the detailed description
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients and may lead to further hospitalization. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP) and from discrepancies between patient's current medications and drugs prescribed at discharge.
Preventing adverse drug events (ADEs) remains a patient safety priority not only in hospitals but also across the continuum of care for patients. Implementing medication reconciliation at all transitions in care is an effective strategy for preventing discrepancies and ADEs. Medication reconciliation prevents and corrects medication errors by promoting transmissions of complete and accurate information about medicines.
Furthermore, ADEs may be the result of a failure to understand and manage post-discharge care needs and can lead to hospital readmission.
We assume that medication reconciliation at discharge, secondarily transmitted to the PCP with a discharge counseling session between the patient and a clinical pharmacist could have a positive impact on the maintenance of therapeutic optimization decided by in-hospital practitioners.
In order to evaluate this assumption, we will conduct a randomized controlled study on 120 patients (as a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge is expected).
The follow-up will last 1 month after discharge from hospital. The first prescription from the PCP will be collected and analyzed. In addition, patients and PCPs will be contacted by the pharmacist to answer specific questionnaires.
The primary objective of the study is to assess the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge.
- Conditions
- Medication Reconciliation
- Being tested
- Reconciliation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReconciliationBehavioural
In addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Medical and pharmaceutical management (at admission, during hospitalization and at discharge) will follow standard healthcare procedures of the department. |
| Reconciliation group | Experimental | Standard healthcare procedures and pharmacist's involvement Receives: Behavioral: Reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge.
The number of in-hospital prescription changes will be evaluated only on discharge prescription transmitted to the patient (after prescription analysis by a clinical pharmacist in the "reconciliation" group)
Compared to the list of all current medications at admission, in-hospital prescription changes include the following:
- Adding a new drug
- Discontinuing a drug
- Drug switch
- Modifying a dose
Among these hospital prescription changes, some will not be maintained by the PCP one month after discharge.
In-hospital prescription changes not maintained by the PCP will be evaluated on the first prescription of the PCP following discharge.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication ReconciliationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocenter, randomized, controlled, pilot study.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederique Bouchand, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Frederique BOUCHAND, PharmD, Principal investigator, APHPBenjamin DAVIDO, MD, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029052
- Sponsor's protocol ID
- 2016-A01628-43
- Acronym
- CONCIVILLE
- Status last verified
- Jul 2020
- First submitted
- 20 Jan 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pilot Study in an Infectious Disease Department Assessing the Impact of Medication Reconciliation at Discharge Associated With a Patient's Counseling Session, Both Provided by a Pharmacist, on Patient's Care After Discharge
- ClinicalTrials.gov ID
- NCT03029052
- Acronym / sponsor ID
- CONCIVILLE / 2016-A01628-43
- Conditions
- Medication Reconciliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 24 Jan 2017 (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.
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). The investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge.
Detailed description
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients and may lead to further hospitalization. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP) and from discrepancies between patient's current medications and drugs prescribed at discharge.
Preventing adverse drug events (ADEs) remains a patient safety priority not only in hospitals but also across the continuum of care for patients. Implementing medication reconciliation at all transitions in care is an effective strategy for preventing discrepancies and ADEs. Medication reconciliation prevents and corrects medication errors by promoting transmissions of complete and accurate information about medicines.
Furthermore, ADEs may be the result of a failure to understand and manage post-discharge care needs and can lead to hospital readmission.
We assume that medication reconciliation at discharge, secondarily transmitted to the PCP with a discharge counseling session between the patient and a clinical pharmacist could have a positive impact on the maintenance of therapeutic optimization decided by in-hospital practitioners.
In order to evaluate this assumption, we will conduct a randomized controlled study on 120 patients (as a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge is expected).
The follow-up will last 1 month after discharge from hospital. The first prescription from the PCP will be collected and analyzed. In addition, patients and PCPs will be contacted by the pharmacist to answer specific questionnaires.
The primary objective of the study is to assess the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocenter, randomized, controlled, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Medical and pharmaceutical management (at admission, during hospitalization and at discharge) will follow standard healthcare procedures of the department. |
| Reconciliation group | Experimental | Behavioral: ReconciliationStandard healthcare procedures and pharmacist's involvement |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years old
- hospitalized in infectious disease department
- with a chronic disease and a current medical prescription including at least three drugs
- discharged home or nursing home
- not opposed to the study
Key exclusion criteria (3 listed)
- foreigners, patients under legal guardianship
- advanced dementia (MMS<20) or phone tracking impossible
- primary care physician opposed to answer questionnaire
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 |
|---|---|---|
| ReconciliationIn addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP. | Behavioural | Reconciliation group |
Primary outcome
Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge.
Time frame: 1 month
The number of in-hospital prescription changes will be evaluated only on discharge prescription transmitted to the patient (after prescription analysis by a clinical pharmacist in the "reconciliation" group) Compared to the list of all current medications at admission, in-hospital prescription changes include the following: * Adding a new drug * Discontinuing a drug * Drug switch * Modifying a dose Among these hospital prescription changes, some will not be maintained by the PCP one month after discharge. In-hospital prescription changes not maintained by the PCP will be evaluated on the first prescription of the PCP following 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 14 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Frederique BOUCHAND, PharmD principal investigator
APHP
Benjamin DAVIDO, MD study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconciliation in people with Medication Reconciliation, run by Centre d'Investigation Clinique et Technologique 805 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 5 inclusion and 3 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 14 Jul 2020. 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?
Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge. (time frame: 1 month). 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 14 Jul 2020.