Clinical trial NCT05799430: Medication Review in Chronic Complex or Polymedicated Patients After Hospital Discharge.
Official title: Effects of Interdisciplinary Medication Review in Chronic Complex Patients or Patients With Polypharmacy After Hospital Discharge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Review
Polypharmacy
Disease, Chronic
Keywords: Medication Review
Polypharmacy
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Andalusian Health Service
First posted: 2023-04-05
Enrollment: 372
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge.

The multidisciplinary team will be integrated by a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). Patient will be adults aged 65 years and older. Polypharmacy refers to the use of 10 or more drugs based on information in electronic prescription software.

Research questions are:

In elderly patients with polypharmacy, which is the effect of an interdisciplinary medication review after hospital discharge in comparison with standard care, in terms of:

* new hospitalization episodes?
* number of drugs prescribed?
* prescribed drugs adequacy?

Detailed description: Centres will be randomized to medication review intervention or usual care group. Eligible patients will be ask for informed consent. For patients in the intervention group, PCP will collect information about prescribed medication and diseases from the electronic health record and e-prescribing application. The medication review in primary care will be focus to reconcile the medications the patient was taking prior to admission and those initiated in hospital, with the medications they should be taking post-discharge to ensure all changes are intentional and that discrepancies are resolved as soon as possible. The review process will include detection of potential drugs interactions, wrong doses, lack of adherence (based on dispensing recorded data) and adequacy to explicit criteria for potentially inappropriate prescriptions included in different tools: a) STOPP-STAR, STOPP-Pal, LESS-CHRON lists; b) Guideline for Medication Review in Primary Care, a local publication and c) Medication review in patients with polypharmacy. A list of drugs frequently associate with potentially inappropriate prescriptions. Andalusian health Service). PCP will write a report to communicate the results of medication review to primary care physician and nurse. The multidisciplinary team will define a personalized therapeutic plan to be implemented for every patient.

Patients in the control group will receive usual care.

Eligibility criteria: Inclusion Criteria:

- Hospital discharge in the last 48 h and one of the following conditions:

* Polypharmacy: ten o more drugs prescribed in a chronic schedule OR
* Complez Chronic Condition

Exclusion Criteria:

* Patients in last days of life
* Major mental health disorder
* Patient on dialysis
* Organ transplant patients

Primary outcomes:
measure: Number of hospitalization episodes
timeFrame: 12 months
measure: Length of Hospital Stay
timeFrame: 12 months
Secondary outcomes:
measure: Healthcare utilisation
timeFrame: 12 months
measure: Mortality
timeFrame: 12 month
measure: Number of potentially inappropriate drugs
timeFrame: 12 months
measure: Number of medications
timeFrame: 12 months
measure: Number of proposal about treatment improvement
timeFrame: 7 days
measure: Number of proposal about treatment improvement agreed with primary care team
timeFrame: 7 days
measure: Number of proposal about treatment improvement accepted by the patient or care
timeFrame: 7 days
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Sevilla Primary Care District
Study officials:
affiliation: Andalusian Health Service. Spain
name: Teresa Molina, Pharm Dr
role: PRINCIPAL_INVESTIGATOR
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