Medication Review in Chronic Complex or Polymedicated Patients After Hospital Discharge: a Randomized Controlled Trial

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799430

Collaborator

Andalusian Health Service (Other)

372

Enrollment

Location

Arms

15.7

Anticipated Duration (Months)

23.7

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Medication Review Polypharmacy Disease, Chronic	Behavioral: Multidisciplinary medication review Behavioral: Control group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

372 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A cluster-randomized control trialA cluster-randomized control trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Effects of Interdisciplinary Medication Review in Chronic Complex Patients or Patients With Polypharmacy After Hospital Discharge: a Cluster Randomized Controlled Clinical Trial in Primary Care

Anticipated Study Start Date :

Apr 10, 2023

Anticipated Primary Completion Date :

Jun 10, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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 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
Active Comparator: Control group The control group will receive usual care.	Behavioral: Control group Usual care by FP an PCN

Arm

Intervention/Treatment

Experimental: Intervention

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

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

Active Comparator: Control group

The control group will receive usual care.

Behavioral: Control group

Usual care by FP an PCN

Outcome Measures

Primary Outcome Measures

Number of hospitalization episodes [12 months]
Registered in Electronic Health Record. In emergency department or in hospital service
Length of Hospital Stay [12 months]
Registered in Electronic Health Record.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sevilla Primary Care District	Sevilla		Spain	41013

Sponsors and Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Andalusian Health Service

Investigators

Principal Investigator: Teresa Molina, Pharm Dr, Andalusian Health Service. Spain

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

ClinicalTrials.gov Identifier:

NCT05799430

Other Study ID Numbers:

S0502

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Medication Review

Polypharmacy

Additional relevant MeSH terms:

Chronic Disease

Study Results

No Results Posted as of Apr 5, 2023