CancerPRIMACNCT02896478
Securing and Optimizing the Patient's Drug Therapy With Cancer: Clinical Pharmacy and Articulation With the City
An observational study of Cancer, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The path of a patient depends largely on his health care network, that is to say of the interrelationships between health professionals who will be involved throughout his career. At the hospital, the transition points in the care process is a vulnerable time for the patient regarding the continuity of his medication. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Mar 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted in oncology unit at Paris Saint joseph Hospital
Who may be able to join
- Patient accepting to be roll on
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The path of a patient depends largely on his health care network, that is to say of the interrelationships between health professionals who will be involved throughout his career. At the hospital, the transition points in the care process is a vulnerable time for the patient regarding the continuity of his medication. These transition points are the intake, the transfer and the outlet. In town, our health system must be able to build on the inter-city hospital, warranty essential guarantee of the continuity of care. However, there is often a breakdown in this relationship with more or less serious consequences ranging from simple dissatisfaction of the patient, to the realization of duplicate examinations or the use unjustified emergency and re-hospitalization. Medication errors can occur, resulting from incomplete information or poorly communicated in this city hospital interface.
The city hospital dysfunctions are mainly organizational, hospital being rather specialized therapeutic approach centered on pathology and medicine city instead focuses on a patient's overall approach.
The involvement of the pharmacist in the hospital, as the city is an interesting axis to develop. In town, the pharmaceutical nomadism, including in major cities remains low, patients generally have a dedicated pharmacies for the treatment of their serious or chronic pathologies. The development of the pharmaceutical folder today allows the pharmacies to access the history and the entire therapy of patients prescribed to town by different specialists and general practitioners, on the last 4 months. Its recent availability within our hospital Group allows us to consider its use to fully optimize the patient's drug monitoring.
Read the detailed description
Hypothesis The involvement of hospital pharmacists from the admission of the patient in the oncology department until its release, with a comprehensive review of its treatment and anticipation of therapeutic needs when returning home and a joint organized with the community pharmacist and doctor, reduces the rate of drug discontinuity and thus improve its therapeutic management.
Goal
The investigators want to integrate and evaluate clinical pharmacist activities at different stages of the patient care process transition points:
- The admission by drug conciliation to determine exhaustively the medication history and the observed differences, and assess the patient's treatment adherence, to consider a revision of the treatment if necessary
- During the stay by daily pharmaceutical validation of drug prescriptions made in DxCare to play down the drug iatrogenic and participate in the definition of pharmacotherapy,
- In preparation for the release of the drug per patient reconciliation to inform and advise the patient about treatment and communicate relevant information to the city of health professionals.
- / DRUG RECONCILIATION TO ENTRY
- Rational The investigators all remember, share different hospital functions, at least one example of Event Junk Medicated (EIM) suffered by a patient, the investigators participate in the management and from a medication error. The frequency of Adverse Event Graves (SAEs) exclusively related to health products is estimated at 1.7 per 1000 SAE avoidable hospital days, or just over 1 SAEs per day for a 1,000 bed hospital. This study showed a stronger exposure to preventable SAEs among elderly and vulnerable. Indeed, promoting factors the occurrence of iatrogenic injuries for this population are manifold: multi-pathologies, polypharmacy, organic impairment, cognitive impairment, inadequate mode of administration. Some of these therapeutic errors are the result of poor communication between the city and the hospital, leading to hospitalized patients for whom took home treatments are not exhaustively known. It is also estimated that 67% of drug history of patients have one or more medication errors and that 46% of these errors occur at the time of the drafting of a new order to the entrance or exit of the patient 's hospital. The EQUIP study showed that the risk of prescription errors was increased by 70% during the intake phase of the patient from the hospital phase. On the other hand, it has been reported that 60% of cancer patients use complementary and alternative medicine, for which we must be vigilant about taking these medications potentially iatrogenic (MAC-AERIO study 2010).
Goal Detect differences in prescription between the city and the hospital in establishing a complete and exhaustive list of treatments taken by the patient before hospitalization, avoiding medication errors, appearance starting point EIG.
procedure The hospitalization of Medical Oncology Service has 20 beds (14 traditional hospital beds and six weeks of hospital beds) with an average rate of entries per day of 3-4 patients, 1 to 2 per week are new patients. Patients will be seen by a hospital pharmacist within <24h of admission, or <72 h during late entry on Friday, Saturday, and Sunday morning.
- / The reconciliation begins with a review of treatments called Bilan Medicated Optimized (BMO). The list to be drawn regarding medications taken by the patient whether prescribed or not. To formalize, it is necessary to conduct an interview with the patient and / or his entourage as well as city health professionals or other care facilities if any. The first source of information is that we will exploit the patient's pharmaceutical record (if open), accessible via its vital card and resuming treatment provided during the last 4 months. If drugs are brought home by the patient, they are another useful source of information. BMO This will be achieved in 2 ways:
- Proactive Patient entering Sunday to Thursday. The drafting of the first order in the service has not yet taken place, BMO is then used to prescriber for the drafting of the Ordinance for Medicinal Products for admission (OMA). Accordingly, the error of drug therapy is intercepted before it takes place. This option requires that conciliation by the pharmacist is made early in the patient's care in the hospital.
- Retroactive for patients who already have a prescription in hospital © DxCare following their admission. BMO is established after drafting the OMA. It can then be discrepancies that conciliation will allow to intercept and correct. It follows writing additional information or a new prescription to correct the detected differences.
- / The differences observed may be unintentional (medication errors) and correspond to involuntary treatment changes and are likely to generate an adverse event for the patient, or intentional but not documented and correspond to voluntary changes in treatment, the reasons are not indicated in the patient file. It may be an addition, modification or interruption of a medicament. This lack of information is likely to generate a medication error later. The characterization of the differences will result in 3 steps:
- Each drug line is characterized by medical decision that seems to have been taken. The drug is thus considered stopped, suspended, continued in the state, continued with amendment, substituted or added.
- Then the search of the annotated medical decision in the patient's file shows that if the decision is documented or not. When it is, the treatment line is validated. When it is not, it is concluded that there was a discrepancy.
- At this late stage, the physician participation is mandatory to describe the degree of intent of the undocumented divergence: divergence is characterized as intentional or unintentional. Following the implementation of the reconciliation rule, three decisions are possible for each drug line studied:
- The drug is validated online
- In case of undocumented intentional discrepancy, the medical decision is to explain by filling in the patient file
- In case of unintended discrepancy, the prescription is correct, there is a medication error. Any deviation must be documented at BMO. The lack of information can leave wrong to think that this discrepancy is intentional or not, hence the importance of documenting prescription for medical decision is explicit. By cons, a gap that is properly called unintentional must be corrected: it is a drug error can cause harm to the patient if it is not caught.
- / The finalized conciliation document is then validated by the hospital pharmacist and ends up embedded in the patient record to be reused during a transfer or discharge.
- Conditions
- Cancer
- Being tested
- No intervention. Only observational study
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Only observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of the Number of pharmaceutical consultations
Measured: Day 0, Day 3, day 30
Assessment of change of the Number of patients discharged
Measured: Day 0, Day 3, day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896478
- Sponsor's protocol ID
- PRIMAC
- Acronym
- PRIMAC
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Securing and Optimizing the Patient's Drug Therapy With Cancer: Clinical Pharmacy and Articulation With the City
- ClinicalTrials.gov ID
- NCT02896478
- Acronym / sponsor ID
- PRIMAC / PRIMAC
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Sep 2016 (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 path of a patient depends largely on his health care network, that is to say of the interrelationships between health professionals who will be involved throughout his career. At the hospital, the transition points in the care process is a vulnerable time for the patient regarding the continuity of his medication. These transition points are the intake, the transfer and the outlet. In town, our health system must be able to build on the inter-city hospital, warranty essential guarantee of the continuity of care. However, there is often a breakdown in this relationship with more or less serious consequences ranging from simple dissatisfaction of the patient, to the realization of duplicate examinations or the use unjustified emergency and re-hospitalization. Medication errors can occur, resulting from incomplete information or poorly communicated in this city hospital interface.
The city hospital dysfunctions are mainly organizational, hospital being rather specialized therapeutic approach centered on pathology and medicine city instead focuses on a patient's overall approach.
The involvement of the pharmacist in the hospital, as the city is an interesting axis to develop. In town, the pharmaceutical nomadism, including in major cities remains low, patients generally have a dedicated pharmacies for the treatment of their serious or chronic pathologies. The development of the pharmaceutical folder today allows the pharmacies to access the history and the entire therapy of patients prescribed to town by different specialists and general practitioners, on the last 4 months. Its recent availability within our hospital Group allows us to consider its use to fully optimize the patient's drug monitoring.
Detailed description
Hypothesis The involvement of hospital pharmacists from the admission of the patient in the oncology department until its release, with a comprehensive review of its treatment and anticipation of therapeutic needs when returning home and a joint organized with the community pharmacist and doctor, reduces the rate of drug discontinuity and thus improve its therapeutic management.
Goal
The investigators want to integrate and evaluate clinical pharmacist activities at different stages of the patient care process transition points:
- The admission by drug conciliation to determine exhaustively the medication history and the observed differences, and assess the patient's treatment adherence, to consider a revision of the treatment if necessary
- During the stay by daily pharmaceutical validation of drug prescriptions made in DxCare to play down the drug iatrogenic and participate in the definition of pharmacotherapy,
- In preparation for the release of the drug per patient reconciliation to inform and advise the patient about treatment and communicate relevant information to the city of health professionals.
- / DRUG RECONCILIATION TO ENTRY
- Rational The investigators all remember, share different hospital functions, at least one example of Event Junk Medicated (EIM) suffered by a patient, the investigators participate in the management and from a medication error. The frequency of Adverse Event Graves (SAEs) exclusively related to health products is estimated at 1.7 per 1000 SAE avoidable hospital days, or just over 1 SAEs per day for a 1,000 bed hospital. This study showed a stronger exposure to preventable SAEs among elderly and vulnerable. Indeed, promoting factors the occurrence of iatrogenic injuries for this population are manifold: multi-pathologies, polypharmacy, organic impairment, cognitive impairment, inadequate mode of administration. Some of these therapeutic errors are the result of poor communication between the city and the hospital, leading to hospitalized patients for whom took home treatments are not exhaustively known. It is also estimated that 67% of drug history of patients have one or more medication errors and that 46% of these errors occur at the time of the drafting of a new order to the entrance or exit of the patient 's hospital. The EQUIP study showed that the risk of prescription errors was increased by 70% during the intake phase of the patient from the hospital phase. On the other hand, it has been reported that 60% of cancer patients use complementary and alternative medicine, for which we must be vigilant about taking these medications potentially iatrogenic (MAC-AERIO study 2010).
Goal Detect differences in prescription between the city and the hospital in establishing a complete and exhaustive list of treatments taken by the patient before hospitalization, avoiding medication errors, appearance starting point EIG.
procedure The hospitalization of Medical Oncology Service has 20 beds (14 traditional hospital beds and six weeks of hospital beds) with an average rate of entries per day of 3-4 patients, 1 to 2 per week are new patients. Patients will be seen by a hospital pharmacist within <24h of admission, or <72 h during late entry on Friday, Saturday, and Sunday morning.
- / The reconciliation begins with a review of treatments called Bilan Medicated Optimized (BMO). The list to be drawn regarding medications taken by the patient whether prescribed or not. To formalize, it is necessary to conduct an interview with the patient and / or his entourage as well as city health professionals or other care facilities if any. The first source of information is that we will exploit the patient's pharmaceutical record (if open), accessible via its vital card and resuming treatment provided during the last 4 months. If drugs are brought home by the patient, they are another useful source of information. BMO This will be achieved in 2 ways:
- Proactive Patient entering Sunday to Thursday. The drafting of the first order in the service has not yet taken place, BMO is then used to prescriber for the drafting of the Ordinance for Medicinal Products for admission (OMA). Accordingly, the error of drug therapy is intercepted before it takes place. This option requires that conciliation by the pharmacist is made early in the patient's care in the hospital.
- Retroactive for patients who already have a prescription in hospital © DxCare following their admission. BMO is established after drafting the OMA. It can then be discrepancies that conciliation will allow to intercept and correct. It follows writing additional information or a new prescription to correct the detected differences.
- / The differences observed may be unintentional (medication errors) and correspond to involuntary treatment changes and are likely to generate an adverse event for the patient, or intentional but not documented and correspond to voluntary changes in treatment, the reasons are not indicated in the patient file. It may be an addition, modification or interruption of a medicament. This lack of information is likely to generate a medication error later. The characterization of the differences will result in 3 steps:
- Each drug line is characterized by medical decision that seems to have been taken. The drug is thus considered stopped, suspended, continued in the state, continued with amendment, substituted or added.
- Then the search of the annotated medical decision in the patient's file shows that if the decision is documented or not. When it is, the treatment line is validated. When it is not, it is concluded that there was a discrepancy.
- At this late stage, the physician participation is mandatory to describe the degree of intent of the undocumented divergence: divergence is characterized as intentional or unintentional. Following the implementation of the reconciliation rule, three decisions are possible for each drug line studied:
- The drug is validated online
- In case of undocumented intentional discrepancy, the medical decision is to explain by filling in the patient file
- In case of unintended discrepancy, the prescription is correct, there is a medication error. Any deviation must be documented at BMO. The lack of information can leave wrong to think that this discrepancy is intentional or not, hence the importance of documenting prescription for medical decision is explicit. By cons, a gap that is properly called unintentional must be corrected: it is a drug error can cause harm to the patient if it is not caught.
- / The finalized conciliation document is then validated by the hospital pharmacist and ends up embedded in the patient record to be reused during a transfer or discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted in oncology unit at Paris Saint joseph Hospital
Key inclusion criteria (1 listed)
- Patient accepting to be roll on
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| No intervention. Only observational study | Other | – |
Primary outcome
Assessment of change of the Number of pharmaceutical consultations
Time frame: Day 0, Day 3, day 30
Assessment of change of the Number of patients discharged
Time frame: Day 0, Day 3, day 30
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 1 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by Fondation Hôpital Saint-Joseph 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 1 inclusion and 1 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 1 Jun 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?
Assessment of change of the Number of pharmaceutical consultations (time frame: Day 0, Day 3, day 30). The study lists 2 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 1 Jun 2018.