AgedMEDREVNCT02598115
Impact of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
A study testing Collaborative Pharmaceutical Care in people with Aged and Patient Admission, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older. This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aged, Patient Admission, Hospitalization
- What is being tested?
- Collaborative Pharmaceutical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Sep 2016to 25 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The patient or his/her legal representative was informed about the study
- The patient is admitted as an in-patient to one of the participating hospitals
- The patient is available for 3 months of follow-up
Who cannot join
- The subject is participating in another drug study
- The subject is under judicial protection
- It is impossible to correctly inform the patient or his/her legal representative
- The patient or his/her legal representative refuses to participate in the study
- The expected life span of the patient is less than the required 3 months of follow-up
- It is impossible to contact the patient after hospitalisation
- Hospitalizatin for longer than 21 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, 38043
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, 06202
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
CHRU de Toulouse - Hôpital Paule de Viguier
Toulouse, 31059
About this study
Official title: Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.
This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.
Read the detailed description
The secondary objectives are to evaluate:
- The potential and observed clinical impact of the implementation of collaborative pharmaceutical care.
- The acceptance rate of pharmaceutical interventions during collaborative pharmaceutical care.
- Avoidable costs related to the consumption of care generated by the occurrence of serious adverse drug reactions.
- The satisfaction of health professionals concerning the transfer of information on the patient's drug therapy carried out as part of collaborative pharmaceutical care.
- Conditions
- Aged, Patient Admission, Hospitalization
- Being tested
- Collaborative Pharmaceutical Care
- Keywords
- collaborative pharmaceutical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Pharmaceutical CareOther
The pharmacist performs collaborative pharmaceutical care in the ward: reconciliation of drug treatments and revision of drug prescriptions indicated on the admission drug prescription. He/she emits pharmaceutical interventions recorded on the standardized support provided by the French Society of Clinical Pharmacy. The pharmaceutical interventions are discussed during a collaborative interview.
| Study group | Role | What they receive |
|---|---|---|
| Before collarborative pharmaceutical care | No intervention | All clusters start in this arm for 15 days. Following the start of the study, 1 randomly chosen cluster will switch to the experimental arm every 15 days. Days 1 to 15: all clusters in the "before arm" Days 16 to 30: 1 cluster in the "Collaborative Pharmaceutical Care" arm Days 31 to 45: 2 clusters in the "Collaborative Pharmaceutical Care" arm Days 46 to 60: 3 clusters in the "Collaborative Pharmaceutical Care" arm Days 61 to 75: 4 clusters in the "Collaborative Pharmaceutical Care" arm Days 76 to 90: 5 clusters in the "Collaborative Pharmaceutical Care" arm Days 91 to 105: all 6 clusters in the "Collaborative Pharmaceutical Care" arm |
| After collarborative pharmaceutical care | Experimental | All clusters start in the "No Intervention" arm for 15 days. Following the start of the study, 1 randomly chosen cluster will switch to the experimental arm every 15 days.
Days 1 to 15: all clusters in the "before arm" Days 16 to 30: 1 cluster in the "Collaborative Pharmaceutical Care" arm Days 31 to 45: 2 clusters in the "Collaborative Pharmaceutical Care" arm Days 46 to 60: 3 clusters in the "Collaborative Pharmaceutical Care" arm Days 61 to 75: 4 clusters in the "Collaborative Pharmaceutical Care" arm Days 76 to 90: 5 clusters in the "Collaborative Pharmaceutical Care" arm Days 91 to 105: all 6 clusters in the "Collaborative Pharmaceutical Care" arm Receives: Other: Collaborative Pharmaceutical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least one preventable medication error
Measured: Day 1 (medical prescription at hospital admission)
Number of patients with at least one preventable medication error
Number of patients with at least one preventable medication error not accepted by the prescribing doctor during the interventional phase
Measured: Phase 2 (maximum 105 days)
Secondary outcomes (10)
Preventable medication error rate
Potential clinical impact: preventable medication error rate detected in the medical prescription at admission (MPA) according to the level of criticality 1, 2 or 3. This error rate is defined by the ratio of the number of avoidable errors to the number of unrevised lines in the MPA.
Measured: Day 1 (medical prescription at hospital admission)
Number of patients at high risk for adverse drug events
Potential clinical impact: number of patients at high risk for adverse drug events (Trivalle score calculated on the medical prescription at hospital admission)
Measured: Day 1 (medical prescription at hospital admission)
Readmission rate for in-patient hospitalization
Clinical impact observed: readmission rate for in-patient hospitalization
Measured: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Readmission rate for in-patient hospitalization
Clinical impact observed: readmission rate for in-patient hospitalization
Measured: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Mortality rate
Measured: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Mortality rate
Measured: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Length of hospital stay
Measured: hospital discharge (expected maximum of 21 days of hospitalization)
Acceptance rate of pharmaceutical interventions during collaborative interview.
Measured: Day 1, hospital admission
Avoided costs related to the occurrence of medication errors (criticality 3)
Measured: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Satisfaction questionnaire (for health care professionals) on the implementation of collaborative pharmaceutical care
Measured: End of study (expected at 195 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start19 Sep 2016
- Primary completion25 Dec 2016
- Study completion25 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgedStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Kinowski, PharmD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598115
- Sponsor's protocol ID
- PREPS/2014/JMK-01
- Other IDs
- 2015-A00421-48
- Acronym
- MEDREV
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2015
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Leguelinel-Blache G, Bouvet S, Bedouch P, Bachelet B, Chenailler C, Dantin T, Geneletti L, Janes A, Scher F, Cireasa B, Kinowski JM, Castelli C, Roux-Marson C; Working Group "Valorisation of Pharmacist Interventions" of the French Society of Clinical Pharmacy; MEDREV working group. Impact of collaborative pharmaceutical care on older inpatients' medication safety: multicentre stepped-wedge cluster randomised trial (MEDREV Study). BMC Geriatr. 2025 Jul 11;25(1):516. doi: 10.1186/s12877-025-06122-1.
PubMed 40646458Leguelinel-Blache G, Castelli C, Roux-Marson C, Bouvet S, Andrieu S, Cestac P, Collomp R, Landais P, Louliere B, Mouchoux C, Varin R, Allenet B; MEDREV Working Group; Bedouch P, Kinowski JM. Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study). Trials. 2018 Jan 8;19(1):19. doi: 10.1186/s13063-017-2412-7.
PubMed 29310711
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
- ClinicalTrials.gov ID
- NCT02598115
- Acronym / sponsor ID
- MEDREV / PREPS/2014/JMK-01
- Conditions
- Aged, Patient Admission, Hospitalization
- Keywords
- collaborative pharmaceutical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 25 Dec 2016 (actual)
- Study completion
- 25 Dec 2016 (actual)
- First posted
- 5 Nov 2015 (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 primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.
This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.
Detailed description
The secondary objectives are to evaluate:
- The potential and observed clinical impact of the implementation of collaborative pharmaceutical care.
- The acceptance rate of pharmaceutical interventions during collaborative pharmaceutical care.
- Avoidable costs related to the consumption of care generated by the occurrence of serious adverse drug reactions.
- The satisfaction of health professionals concerning the transfer of information on the patient's drug therapy carried out as part of collaborative pharmaceutical care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before collarborative pharmaceutical care | No intervention | –All clusters start in this arm for 15 days. Following the start of the study, 1 randomly chosen cluster will switch to the experimental arm every 15 days. Days 1 to 15: all clusters in the "before arm" Days 16 to 30: 1 cluster in the "Collaborative Pharmaceutical Care" arm Days 31 to 45: 2 clusters in the "Collaborative Pharmaceutical Care" arm Days 46 to 60: 3 clusters in the "Collaborative Pharmaceutical Care" arm Days 61 to 75: 4 clusters in the "Collaborative Pharmaceutical Care" arm Days 76 to 90: 5 clusters in the "Collaborative Pharmaceutical Care" arm Days 91 to 105: all 6 clusters in the "Collaborative Pharmaceutical Care" arm |
| After collarborative pharmaceutical care | Experimental | Other: Collaborative Pharmaceutical CareAll clusters start in the "No Intervention" arm for 15 days. Following the start of the study, 1 randomly chosen cluster will switch to the experimental arm every 15 days. Days 1 to 15: all clusters in the "before arm" Days 16 to 30: 1 cluster in the "Collaborative Pharmaceutical Care" arm Days 31 to 45: 2 clusters in the "Collaborative Pharmaceutical Care" arm Days 46 to 60: 3 clusters in the "Collaborative Pharmaceutical Care" arm Days 61 to 75: 4 clusters in the "Collaborative Pharmaceutical Care" arm Days 76 to 90: 5 clusters in the "Collaborative Pharmaceutical Care" arm Days 91 to 105: all 6 clusters in the "Collaborative Pharmaceutical Care" arm |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- The patient or his/her legal representative was informed about the study
- The patient is admitted as an in-patient to one of the participating hospitals
- The patient is available for 3 months of follow-up
Key exclusion criteria (7 listed)
- The subject is participating in another drug study
- The subject is under judicial protection
- It is impossible to correctly inform the patient or his/her legal representative
- The patient or his/her legal representative refuses to participate in the study
- The expected life span of the patient is less than the required 3 months of follow-up
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 |
|---|---|---|
| Collaborative Pharmaceutical CareThe pharmacist performs collaborative pharmaceutical care in the ward: reconciliation of drug treatments and revision of drug prescriptions indicated on the admission drug prescription. He/she emits pharmaceutical interventions recorded on the standardized support provided by the French Society of Clinical Pharmacy. The pharmaceutical interventions are discussed during a collaborative interview. | Other | After collarborative pharmaceutical care |
Primary outcome
Number of patients with at least one preventable medication error
Time frame: Day 1 (medical prescription at hospital admission)
Number of patients with at least one preventable medication error
Time frame: Phase 2 (maximum 105 days)
Number of patients with at least one preventable medication error not accepted by the prescribing doctor during the interventional phase
10 secondary outcomes
Preventable medication error rate
Time frame: Day 1 (medical prescription at hospital admission)
Number of patients at high risk for adverse drug events
Time frame: Day 1 (medical prescription at hospital admission)
Readmission rate for in-patient hospitalization
Time frame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Readmission rate for in-patient hospitalization
Time frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Mortality rate
Time frame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Mortality rate
Time frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Length of hospital stay
Time frame: hospital discharge (expected maximum of 21 days of hospitalization)
Acceptance rate of pharmaceutical interventions during collaborative interview.
Time frame: Day 1, hospital admission
Avoided costs related to the occurrence of medication errors (criticality 3)
Time frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Satisfaction questionnaire (for health care professionals) on the implementation of collaborative pharmaceutical care
Time frame: End of study (expected at 195 days)
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 28 Feb 2020.
- Derived from this study: PubMed 40646458Leguelinel-Blache G, Bouvet S, Bedouch P, Bachelet B, Chenailler C, Dantin T, Geneletti L, Janes A, Scher F, Cireasa B, Kinowski JM, Castelli C, Roux-Marson C; Working Group "Valorisation of Pharmacist Interventions" of the French Society of Clinical Pharmacy; MEDREV working group. Impact of collaborative pharmaceutical care on older inpatients' medication safety: multicentre stepped-wedge cluster randomised trial (MEDREV Study). BMC Geriatr. 2025 Jul 11;25(1):516. doi: 10.1186/s12877-025-06122-1.
- Derived from this study: PubMed 29310711Leguelinel-Blache G, Castelli C, Roux-Marson C, Bouvet S, Andrieu S, Cestac P, Collomp R, Landais P, Louliere B, Mouchoux C, Varin R, Allenet B; MEDREV Working Group; Bedouch P, Kinowski JM. Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study). Trials. 2018 Jan 8;19(1):19. doi: 10.1186/s13063-017-2412-7.
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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.
Jean-Marie Kinowski, PharmD principal investigator
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Pharmaceutical Care in people with Aged and Patient Admission, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 7 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 28 Feb 2020. 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?
Number of patients with at least one preventable medication error (time frame: Day 1 (medical prescription at hospital admission)). 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?
On the ClinicalTrials.gov record for NCT02598115, which also lists 2 linked publications.
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 28 Feb 2020.