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

September 13, 2023 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:

  1. 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.
  2. 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.
  3. FP, PCN and PCP agree on a personalized therapeutic plan for the patient that includes actions to optimize the therapy.
  4. FP and PCN share plan with the patient and/or carer with possible adaptation of the recommendations and agree about actions to be implemented.
  5. FP and PCN communicate to PCP final agreement with patient and/or carer
  6. 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Andalusian Health Service

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Estimated)

June 10, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S0502 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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