Medication Review in Chronic Complex or Polymedicated Patients After Hospital Discharge.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Interdisciplinary Medication Review in Chronic Complex Patients or Patients With Polypharmacy After Hospital Discharge

Conditions
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Medication Review, Polypharmacy, Disease, Chronic

Intervention / Treatment
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* Behavioral: Multidisciplinary medication review
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A cluster-randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group will receive a multidisciplinary medication review and a personalized therapeutic plan in the following 72 hours after hospital discharge. The intervention will be developed by a multidisciplinary team that includes a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). PCP is a pharmacist working in a full-time base for the Pharmacy Service in a Primary Care District in Andalusian Public Health Service. | Behavioral: Multidisciplinary medication review<br>* FP communicate to the PCP patients recently discharged. The medication review process consists in 5 steps: PCP perform a structured drug review based on information from health record and e-prescribing application. The drug review comprise the appraisal of potentially inappropriate medication based on lists of explicit criteria. PCP communicates and discuss the results of medication review with GP and PCN, in a brief meeting face-to-face, with possible adaptation of the recommendations. FP, PCN and PCP agree on a personalized therapeutic plan for the patient that includes actions to optimize the therapy. FP and PCN share plan with the patient and/or carer with possible adaptation of the recommendations and agree about actions to be implemented. FP and PCN communicate to PCP final agreement with patient and/or carer FP and/or PCN follow-up implantation of agreed recommendations using standard health care procedures<br>|
| Active Comparator: Control group<br>The control group will receive usual care. | Behavioral: Control group<br>* Usual care by FP an PCN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalization episodes | Registered in Electronic Health Record. In emergency department or in hospital service | 12 months | 
| Length of Hospital Stay | Registered in Electronic Health Record. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilisation | Number of visits to primary care services (family physician or primary care nurse) and hospital services (non emergency and without hospitalization) | 12 months | 
| Mortality | Dead for any cause | 12 month | 
| Number of potentially inappropriate drugs | Total number of potentially inappropriate prescribed drugs based on explicit criteria | 12 months | 
| Number of medications | Total number of drugs chronically prescribed (treatment length: unless 120 days) | 12 months | 
| Number of proposal about treatment improvement | Number of proposal about treatment improvement included in PCP report | 7 days | 
| Number of proposal about treatment improvement agreed with primary care team | Number of proposal about treatment improvement agreed with primary care team in a face face meeting | 7 days | 
| Number of proposal about treatment improvement accepted by the patient or care | Number of proposal about treatment improvement agreed with primary care team in a face face meeting | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Review, Polypharmacy