Medication ReconciliationCONTEMPSNCT03670433
Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital
An observational study of Medication Reconciliation, run by Rennes University Hospital at 1 site in France.
Trial summary
Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Reconciliation
- What is being tested?
- Cost analysis of medication reconciliation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2017to 31 Oct 2017
- 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 at the UMIP of Rennes University Hospital between 09/04/2017 and 10/31/2017.
Who may be able to join
- Patients over 65 years old
- Patient non-institutionalized at entry
- For MR :
- Entry : patients admitted at UMIP between 09/04/2017 and 10/31/2017
- Discharge : patients returning home or going to a rehabilitation service between 04/09/2017 and 31/10/2017 and having received MR evaluation
Who cannot join
- Patients not returning home
- Refusal of participation
- Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
Trial locations and contacts
1 site in 1 country.
About this study
Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.
Read the detailed description
All medication errors are not serious. Nevertheless 4 studies show that respectively 5.6%, 5.7%, 6.3% and 11.7% of the medication errors intercepted by medication reconciliation (MR) could have had major, critical or catastrophic consequences for patients. If the consequences of a medication error have a clinical or institutional translation for the patient, they can also directly impact the hospital or caregivers, for example by extending the average length of stay or by increasing the number of consultations or readmissions.
The efficiency of the medication reconciliation approach has never been evaluated in France in comparison with standard care. Before initiating cost-effectiveness studies, we propose to conduct a micro-costing study to evaluate the production costs of this conciliation approach.
The costs are almost exclusively related to human resources and the present study will assess the time spent by the different actors involved in the process.
- Conditions
- Medication Reconciliation
- Being tested
- Cost analysis of medication reconciliation
- Keywords
- Medication reconciliation, Care path, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cost analysis of medication reconciliationOther
- The MR at entry is performed by the pharmaceutical team as soon as possible after admission. The sequences of the medical conciliation are attributed to the health professionals according to the recommendations of the French National Authority for Health (HAS).
- The MR at the discharge is carried out in collaboration between the pharmaceutical and medical teams. It associates the patient through pharmaceutical interview and relies on the sharing of informations related to the patient's medical treatments. These informations are synthesized in an output conciliation sheet transmitted in real time by secure messaging to the attending physician and the dispensing pharmacist. In parallel, the liaison letter and the patient discharge order are generated in order to guarantee a perfect homogeneity between all the documents transmitted at the patient's exit. MR sequences are attributed to health professionals according to the recommendations of the HAS.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted in the Polyvalent Internal Medical Unit | Patients over 65 years old admitted in the Polyvalent Internal Medical Unit (UMIP) of Rennes University Hospital between 09/04/2017 and 10/31/2017 or going back home or to a rehabilitation service during the same period.
Cost analysis of medication reconciliation. Receives: Other: Cost analysis of medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent by professionals
Evaluation of the time spent by each professionals involved in the completion of each step of the MR process.
Measured: At the inclusion day
Average cost of MR process
Evaluation of average cost of MR process at UMIP. Only costs related to human resources are considered.
Measured: At the inclusion day
Number of unintentional discrepancies detected
Number of unintentional discrepancies detected during MR at admission of patients at UMIP.
Measured: At the inclusion day
Severity of unintentional discrepancies detected
Severity of unintentional discrepancies detected during MR at admission of patients at UMIP. Evaluation based on the algorithm provided by the HAS.
Measured: At the inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start5 Sep 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
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.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berengere CADOR, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670433
- Sponsor's protocol ID
- 35RC17_3081
- Acronym
- CONTEMPS
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital
- ClinicalTrials.gov ID
- NCT03670433
- Acronym / sponsor ID
- CONTEMPS / 35RC17_3081
- Conditions
- Medication Reconciliation
- Keywords
- Medication reconciliation, Care path, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 13 Sep 2018 (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.
Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.
Detailed description
All medication errors are not serious. Nevertheless 4 studies show that respectively 5.6%, 5.7%, 6.3% and 11.7% of the medication errors intercepted by medication reconciliation (MR) could have had major, critical or catastrophic consequences for patients. If the consequences of a medication error have a clinical or institutional translation for the patient, they can also directly impact the hospital or caregivers, for example by extending the average length of stay or by increasing the number of consultations or readmissions.
The efficiency of the medication reconciliation approach has never been evaluated in France in comparison with standard care. Before initiating cost-effectiveness studies, we propose to conduct a micro-costing study to evaluate the production costs of this conciliation approach.
The costs are almost exclusively related to human resources and the present study will assess the time spent by the different actors involved in the process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted in the Polyvalent Internal Medical Unit | – | Other: Cost analysis of medication reconciliationPatients over 65 years old admitted in the Polyvalent Internal Medical Unit (UMIP) of Rennes University Hospital between 09/04/2017 and 10/31/2017 or going back home or to a rehabilitation service during the same period. Cost analysis of medication reconciliation. |
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 at the UMIP of Rennes University Hospital between 09/04/2017 and 10/31/2017.
Key inclusion criteria (5 listed)
- Patients over 65 years old
- Patient non-institutionalized at entry
- For MR :
Key exclusion criteria (3 listed)
- Patients not returning home
- Refusal of participation
- Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
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 |
|---|---|---|
| Cost analysis of medication reconciliation1. The MR at entry is performed by the pharmaceutical team as soon as possible after admission. The sequences of the medical conciliation are attributed to the health professionals according to the recommendations of the French National Authority for Health (HAS). 2. The MR at the discharge is carried out in collaboration between the pharmaceutical and medical teams. It associates the patient through pharmaceutical interview and relies on the sharing of informations related to the patient's medical treatments. These informations are synthesized in an output conciliation sheet transmitted in real time by secure messaging to the attending physician and the dispensing pharmacist. In parallel, the liaison letter and the patient discharge order are generated in order to guarantee a perfect homogeneity between all the documents transmitted at the patient's exit. MR sequences are attributed to health professionals according to the recommendations of the HAS. | Other | Patients admitted in the Polyvalent Internal Medical Unit |
Primary outcome
Time spent by professionals
Time frame: At the inclusion day
Evaluation of the time spent by each professionals involved in the completion of each step of the MR process.
Average cost of MR process
Time frame: At the inclusion day
Evaluation of average cost of MR process at UMIP. Only costs related to human resources are considered.
Number of unintentional discrepancies detected
Time frame: At the inclusion day
Number of unintentional discrepancies detected during MR at admission of patients at UMIP.
Severity of unintentional discrepancies detected
Time frame: At the inclusion day
Severity of unintentional discrepancies detected during MR at admission of patients at UMIP. Evaluation based on the algorithm provided by the HAS.
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 13 Sep 2018.
- 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.
Berengere CADOR, MD principal investigator
Rennes University Hospital
1 site 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, run by Rennes University Hospital 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 13 Sep 2018. 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?
Time spent by professionals (time frame: At the inclusion day). The study lists 4 primary outcomes in all. 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 13 Sep 2018.