Re-hospitalizationConcReHospNCT02734017
Impact of a Medication Review on Hospital Readmission: (ConcReHosp)
A study testing pharmacist-led standardized medication review in people with Re-hospitalization, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups: 1. group receiving a pharmacist-led standardized medication review (experimental group); and 2. group not receiving the medication review (control group). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Re-hospitalization
- What is being tested?
- pharmacist-led standardized medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2016to 23 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects aged under 18 or over 65 years
- Subject hospitalized in the multidisciplinary pediatric service or internal medicine ward, after emergency department visit at Timone hospital (Marseille, France) regardless of the reason for admission
- Subject with or without any comorbidity
- Living in France
- With national publicly-founded health insurance
- Major subject and/or holder of parental authority of a hospitalized child, who fulfills the eligibility criteria mentioned above, in the multidisciplinary pediatric ward;
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- Whatever the reason for hospitalization of the patient;
- Inclusion criteria for the caregivers of patients older than 65 years:
- Major subject, designated by the patient or designating himself as the person most involved in the daily life of the patient;
- Whatever the reason for hospitalization of the patient;
- Whatever relationship or proximity to the study patient (family member, friend, neighbor);
Who cannot join
- Patients whose care requires regular re-hospitalization / programmed less than 30 days after discharge of initial hospitalization
- Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, 13354
About this study
Official title: Impact of a Medication Review on Hospital Readmission: Study Protocol of a Randomized Controlled Trial
The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:
- group receiving a pharmacist-led standardized medication review (experimental group); and
- group not receiving the medication review (control group).
Read more
The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.
Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review on early hospital readmission for extreme age population.
Read the detailed description
The impact of Medication Reconciliation on the early hospital readmission in the elderly is not clearly demonstrated. Moreover, the impact of medication reconciliation in the pediatric population is poorly studied.
In such context, it is important to demonstrate the effectiveness of the medication reconciliation as part of a standardized medication review process, in pediatric and in the elderly, on all cause readmissions in a large randomized control clinical trial. The standardized medication review process includes medication reconciliation, treatment review and medication liaison service.
The main objective of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge.
Methods/design: The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:
- group receiving a pharmacist-led standardized medication review (experimental group); and
- group not receiving the medication review (control group).
The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.
Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review.
- Conditions
- Re-hospitalization
- Being tested
- pharmacist-led standardized medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacist-led standardized medication reviewOther
the goal of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge.
| Study group | Role | What they receive |
|---|---|---|
| standard course | Other | group not receiving medication review Receives: Other: pharmacist-led standardized medication review |
| pharmacist-led standardized medication review | Other | pharmacist-led standardized medication review including :
* Medical and pharmaceutical admission medication reconciliation and treatment review
* Medical and pharmaceutical medication reconciliation at discharge and treatment review
* Medication Liaison Service Receives: Other: pharmacist-led standardized medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of readmission
Measured: 30 days
Secondary outcomes (3)
Satisfaction with Medicines Questionnaire (SatMed-Q®)
Patient satisfaction with regards to its drug treatment will be measured using the standardized questionnaire "Satisfaction with Medicines Questionnaire (SatMed-Q®)" validated in French
Measured: 30 days
Medication errors on medical admission prescription
Medical admission prescription will be assessed using the number of discrepancies and the number of medication errors,
Measured: 24 hours
Number of consultations post discharge
The number of consultations scheduled or not within 30 days' post-hospitalization will be studied. Consultations are defined as interviews with the attending physician, a specialist physician, nurse, therapeutic educator, and psychologist.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start1 Jul 2016
- Primary completion2 Jan 2019
- Study completion23 Mar 2019
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 Re-hospitalizationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734017
- Sponsor's protocol ID
- 2015-20
- Acronym
- ConcReHosp
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Renaudin P, Baumstarck K, Daumas A, Esteve MA, Gayet S, Auquier P, Tsimaratos M, Villani P, Honore S. Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial. Trials. 2017 Feb 9;18(1):65. doi: 10.1186/s13063-017-1798-6.
PubMed 28183322
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Medication Review on Hospital Readmission: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02734017
- Acronym / sponsor ID
- ConcReHosp / 2015-20
- Conditions
- Re-hospitalization
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 12 Apr 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 study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:
- group receiving a pharmacist-led standardized medication review (experimental group); and
- group not receiving the medication review (control group).
The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.
Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review on early hospital readmission for extreme age population.
Detailed description
The impact of Medication Reconciliation on the early hospital readmission in the elderly is not clearly demonstrated. Moreover, the impact of medication reconciliation in the pediatric population is poorly studied.
In such context, it is important to demonstrate the effectiveness of the medication reconciliation as part of a standardized medication review process, in pediatric and in the elderly, on all cause readmissions in a large randomized control clinical trial. The standardized medication review process includes medication reconciliation, treatment review and medication liaison service.
The main objective of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge.
Methods/design: The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:
- group receiving a pharmacist-led standardized medication review (experimental group); and
- group not receiving the medication review (control group).
The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.
Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard course | Other | Other: pharmacist-led standardized medication reviewgroup not receiving medication review |
| pharmacist-led standardized medication review | Other | Other: pharmacist-led standardized medication reviewpharmacist-led standardized medication review including : * Medical and pharmaceutical admission medication reconciliation and treatment review * Medical and pharmaceutical medication reconciliation at discharge and treatment review * Medication Liaison Service |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects aged under 18 or over 65 years
- Subject hospitalized in the multidisciplinary pediatric service or internal medicine ward, after emergency department visit at Timone hospital (Marseille, France) regardless of the reason for admission
- Subject with or without any comorbidity
- Living in France
- With national publicly-founded health insurance
Key exclusion criteria (2 listed)
- Patients whose care requires regular re-hospitalization / programmed less than 30 days after discharge of initial hospitalization
- Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of 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 |
|---|---|---|
| pharmacist-led standardized medication reviewthe goal of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge. | Other | pharmacist-led standardized medication review, standard course |
Primary outcome
Rate of readmission
Time frame: 30 days
3 secondary outcomes
Satisfaction with Medicines Questionnaire (SatMed-Q®)
Time frame: 30 days
Medication errors on medical admission prescription
Time frame: 24 hours
Number of consultations post discharge
Time frame: 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 28183322Renaudin P, Baumstarck K, Daumas A, Esteve MA, Gayet S, Auquier P, Tsimaratos M, Villani P, Honore S. Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial. Trials. 2017 Feb 9;18(1):65. doi: 10.1186/s13063-017-1798-6.
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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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacist-led standardized medication review in people with Re-hospitalization, run by Assistance Publique Hopitaux De Marseille 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 11 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Jul 2023. 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 was stopped early. Results are not available in the source record.
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?
Rate of readmission (time frame: 30 days). 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 NCT02734017, 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 27 Jul 2023.