Clinical trial NCT02734017: Impact of a Medication Review on Hospital Readmission: (ConcReHosp)
Official title: Impact of a Medication Review on Hospital Readmission: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Re-hospitalization
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 470
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

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:

1. group receiving a pharmacist-led standardized medication review (experimental group); and
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Inclusion criteria for parents of minor child:

* Major subject and/or holder of parental authority of a hospitalized child, who fulfills the eligibility criteria mentioned above, in the multidisciplinary pediatric ward;
* 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);

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Rate of readmission
timeFrame: 30 days
Secondary outcomes:
measure: Satisfaction with Medicines Questionnaire (SatMed-Q®)
timeFrame: 30 days
measure: Medication errors on medical admission prescription
timeFrame: 24 hours
measure: Number of consultations post discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
citation: 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.