Medication Reconciliation at DischargeCONPARMEDNCT04018781
Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy
An observational study of Medication Reconciliation at Discharge, run by Rennes University Hospital at 6 sites in France.
Trial summary
In the context of the ageing of the French population, drug iatrogeny in the elderly is a major public health issue, responsible for approximately 7,500 deaths per year and 3.4% of hospitalizations among patients aged 65 and over. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Reconciliation at Discharge
- What is being tested?
- medication reconciliation
- How many people
- 443 participants
- Where
- 6 sitesFrance
- Study dates
- 13 Jun 2019to 13 Feb 2020
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 65 years admitted inside one of the thirteen wards from 6 hospitals located around Rennes and Fougères, between 13/06/2019 and 13/09/2019
Who may be able to join
- Patient > 65 years old
- Patient hospitalized inside one of the thirteen wards in the 6 hospitals participating in the study
- Informed consent given
- Non inclusion and Exclusion Criteria :
- Patients in palliative care
- Persons deprived of their liberty
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hopital des Marches de Bretagne
Antrain, 35560
General Hospital
Fougères, 35306
General Hospital
Janzé, 35150
General Hospital
Montfort-sur-Meu, 35160
University Hospital
Rennes, 35000
General Hospital
Saint-Méen-le-Grand, 35290
About this study
Official title: Eval CONPARMED Haute-Bretagne : Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy
In the context of the ageing of the French population, drug iatrogeny in the elderly is a major public health issue, responsible for approximately 7,500 deaths per year and 3.4% of hospitalizations among patients aged 65 and over.
The interest of the Medication Reconciliation (MR) in reducing medication errors and unintentional discrepancies in prescriptions at transition points in patients' medication care pathways no longer seems to be in doubt both in France and abroad.
On the other hand, the literature on the clinical impact of these drug errors (i. e. occurrence of an adverse drug event (ADE) or readmission rates) is currently limited in France and presents variable results abroad.
Read the detailed description
The medication reconciliation implementation mobilizes human resources (pharmacists, pharmacy technician, nurses...) and constitutes an investment for healthcare institutions. However, the resulting improvement in patients' health status (and the potential reduction in ADEs) could reduce their care consumption and thus reduce costs from a healthcare system perspective. We therefore propose to assess the cost-effectiveness of this care strategy.
Finally, we will study the impact of the MR deployment on existing professional organizations, both in hospital and between community healthcare professionals and hospital as well as its conditions of implementation.
- Conditions
- Medication Reconciliation at Discharge
- Being tested
- medication reconciliation
- Keywords
- Medication reconciliation, clinical pharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication reconciliationOther
During hospitalization, the hospital pharmacist will carry out a pharmaceutical analysis for all patients included in the study, each time the prescription is changed and within a maximum of 24 hours (working days).
If necessary, in consultation with the doctor in charge of the patient, the pharmacist may also propose a pharmaceutical interview to the patient at any time during his hospitalisation (e.g. proposal for the de-prescription of benzodiazepines, Proton Pump Inhibitors, etc., according to the recommendations in force).
| Study group | Role | What they receive |
|---|---|---|
| MR group | Patients who benefit from a full process of medication reconciliation (entrance and discharge) before being discharged to home. Receives: Other: medication reconciliation | |
| Control group | Patients who benefitted from a medication reconciliation at entrance only before being discharged to home. Receives: Other: medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug event-related hospital revisits
Rate of adverse drug event-related hospital revisits within 30 days after discharge
Measured: 30 days after discharge
Secondary outcomes (9)
General Practitioner consultation
Rate of General Practitioner consultation within 30 days after discharge
Measured: 30 days after discharge
All-causes readmissions and/or Emergency Department visits
Composite rate of readmissions and/or Emergency Department visits within 30 days after discharge
Measured: 30 days after discharge
All-causes readmissions and/or Emergency Department visits
Composite rate of readmissions and/or Emergency Department visits within 90 days after discharge
Measured: 90 days after discharge
Incremental Cost-Effectiveness Ratio (ICER) at Day 30
Medico-economic analysis : Incremental Cost-Effectiveness Ratio (ICER) : cost per hospitalization for Drug Adverse Event avoided and cost per all-causes hospitalization, according to a collective perspective at Day 0.
Measured: 30 days after discharge
Incremental Cost-Effectiveness Ratio (ICER) at Day 90
Medico-economic analysis : Incremental Cost-Effectiveness Ratio (ICER) : cost per hospitalization for Drug Adverse Event avoided and cost per all-causes hospitalization, according to a collective perspective at Day 90.
Measured: 90 days after discharge
Patient reported experience measures
Patient reported experience measures are realized by a short phone call interview, 7 days after the patients' homecoming
Measured: 7 days after discharge
Severity of Unintended Medication Discrepancies
Severity of Unintended Medication Discrepancies intercepted during medication reconciliation at admission
Measured: At admission
Number of Unintended Medication Discrepancies
Number of Unintended Medication Discrepancies intercepted during medication reconciliation at admission
Measured: At admission
Impact of the implementation of the intervention on professional organizations
Qualitative analysis based on :
- First, an inventory of organizations prior to the implementation of the intervention in participating health facilities
- Then, an assessment of the impacts of the implementation of the intervention on different aspects of professional organizations: collaborative exchanges, multi-professional information sharing, division of labour, exchanges with city practitioners, learning effects, evolution of professional practices.
Measured: Before and after the implementation of the intervention in the participating wards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start13 Jun 2019
- Primary completion13 Nov 2019
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication Reconciliation at DischargeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Responsible party
- Sponsor
- Investigators
- Benoit HUE, MD, PhD, Study director, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018781
- Sponsor's protocol ID
- 35RC19_30022
- Other IDs
- 2019-A00455-52
- Acronym
- CONPARMED
- Status last verified
- Aug 2021
- First submitted
- 9 Jul 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bajeux E, Alix L, Cornee L, Barbazan C, Mercerolle M, Howlett J, Cruveilhier V, Line-Iehl C, Cador B, Jego P, Gicquel V, Schweyer FX, Marie V, Hamonic S, Josselin JM, Somme D, Hue B. Pharmacist-led medication reconciliation at patient discharge: a tool to reduce healthcare utilization? an observational study in patients 65 years or older. BMC Geriatr. 2022 Jul 13;22(1):576. doi: 10.1186/s12877-022-03192-3.
PubMed 35831783
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eval CONPARMED Haute-Bretagne : Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy
- ClinicalTrials.gov ID
- NCT04018781
- Acronym / sponsor ID
- CONPARMED / 35RC19_30022
- Conditions
- Medication Reconciliation at Discharge
- Keywords
- Medication reconciliation, clinical pharmacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 15 Jul 2019 (actual)
- 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.
In the context of the ageing of the French population, drug iatrogeny in the elderly is a major public health issue, responsible for approximately 7,500 deaths per year and 3.4% of hospitalizations among patients aged 65 and over.
The interest of the Medication Reconciliation (MR) in reducing medication errors and unintentional discrepancies in prescriptions at transition points in patients' medication care pathways no longer seems to be in doubt both in France and abroad.
On the other hand, the literature on the clinical impact of these drug errors (i. e. occurrence of an adverse drug event (ADE) or readmission rates) is currently limited in France and presents variable results abroad.
Detailed description
The medication reconciliation implementation mobilizes human resources (pharmacists, pharmacy technician, nurses...) and constitutes an investment for healthcare institutions. However, the resulting improvement in patients' health status (and the potential reduction in ADEs) could reduce their care consumption and thus reduce costs from a healthcare system perspective. We therefore propose to assess the cost-effectiveness of this care strategy.
Finally, we will study the impact of the MR deployment on existing professional organizations, both in hospital and between community healthcare professionals and hospital as well as its conditions of implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR group | – | Other: medication reconciliationPatients who benefit from a full process of medication reconciliation (entrance and discharge) before being discharged to home. |
| Control group | – | Other: medication reconciliationPatients who benefitted from a medication reconciliation at entrance only before being discharged to home. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years admitted inside one of the thirteen wards from 6 hospitals located around Rennes and Fougères, between 13/06/2019 and 13/09/2019
Key inclusion criteria (6 listed)
- Patient > 65 years old
- Patient hospitalized inside one of the thirteen wards in the 6 hospitals participating in the study
- Informed consent given
- Patients in palliative care
- Persons deprived of their liberty
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| medication reconciliationDuring hospitalization, the hospital pharmacist will carry out a pharmaceutical analysis for all patients included in the study, each time the prescription is changed and within a maximum of 24 hours (working days). If necessary, in consultation with the doctor in charge of the patient, the pharmacist may also propose a pharmaceutical interview to the patient at any time during his hospitalisation (e.g. proposal for the de-prescription of benzodiazepines, Proton Pump Inhibitors, etc., according to the recommendations in force). | Other | Control group, MR group |
Primary outcome
Adverse drug event-related hospital revisits
Time frame: 30 days after discharge
Rate of adverse drug event-related hospital revisits within 30 days after discharge
9 secondary outcomes
General Practitioner consultation
Time frame: 30 days after discharge
All-causes readmissions and/or Emergency Department visits
Time frame: 30 days after discharge
All-causes readmissions and/or Emergency Department visits
Time frame: 90 days after discharge
Incremental Cost-Effectiveness Ratio (ICER) at Day 30
Time frame: 30 days after discharge
Incremental Cost-Effectiveness Ratio (ICER) at Day 90
Time frame: 90 days after discharge
Patient reported experience measures
Time frame: 7 days after discharge
Severity of Unintended Medication Discrepancies
Time frame: At admission
Number of Unintended Medication Discrepancies
Time frame: At admission
Impact of the implementation of the intervention on professional organizations
Time frame: Before and after the implementation of the intervention in the participating wards
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 5 Aug 2021.
- Derived from this study: PubMed 35831783Bajeux E, Alix L, Cornee L, Barbazan C, Mercerolle M, Howlett J, Cruveilhier V, Line-Iehl C, Cador B, Jego P, Gicquel V, Schweyer FX, Marie V, Hamonic S, Josselin JM, Somme D, Hue B. Pharmacist-led medication reconciliation at patient discharge: a tool to reduce healthcare utilization? an observational study in patients 65 years or older. BMC Geriatr. 2022 Jul 13;22(1):576. doi: 10.1186/s12877-022-03192-3.
- Individual participant dataSharing planned: No
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.
Benoit HUE, MD, PhD study director
University Hospital of Rennes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Reconciliation at Discharge, run by Rennes University Hospital at 6 sites 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 6 inclusion and 0 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 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Adverse drug event-related hospital revisits (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018781, which also lists 1 linked publication.
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 5 Aug 2021.