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

Primary Purpose

Medication Review, Polypharmacy, Disease, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidisciplinary medication review
Control group
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Review focused on measuring Medication Review, Polypharmacy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sevilla Primary Care DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control group

Arm Description

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.

The control group will receive usual care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Healthcare utilisation
Number of visits to primary care services (family physician or primary care nurse) and hospital services (non emergency and without hospitalization)
Mortality
Dead for any cause
Number of potentially inappropriate drugs
Total number of potentially inappropriate prescribed drugs based on explicit criteria
Number of medications
Total number of drugs chronically prescribed (treatment length: unless 120 days)
Number of proposal about treatment improvement
Number of proposal about treatment improvement included in PCP report
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
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

Full Information

First Posted
March 23, 2023
Last Updated
September 13, 2023
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Andalusian Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT05799430
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
Andalusian Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Review, Polypharmacy, Disease, Chronic
Keywords
Medication Review, Polypharmacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A cluster-randomized control trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary medication review
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Usual care by FP an PCN
Primary Outcome Measure Information:
Title
Number of hospitalization episodes
Description
Registered in Electronic Health Record. In emergency department or in hospital service
Time Frame
12 months
Title
Length of Hospital Stay
Description
Registered in Electronic Health Record.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Healthcare utilisation
Description
Number of visits to primary care services (family physician or primary care nurse) and hospital services (non emergency and without hospitalization)
Time Frame
12 months
Title
Mortality
Description
Dead for any cause
Time Frame
12 month
Title
Number of potentially inappropriate drugs
Description
Total number of potentially inappropriate prescribed drugs based on explicit criteria
Time Frame
12 months
Title
Number of medications
Description
Total number of drugs chronically prescribed (treatment length: unless 120 days)
Time Frame
12 months
Title
Number of proposal about treatment improvement
Description
Number of proposal about treatment improvement included in PCP report
Time Frame
7 days
Title
Number of proposal about treatment improvement agreed with primary care team
Description
Number of proposal about treatment improvement agreed with primary care team in a face face meeting
Time Frame
7 days
Title
Number of proposal about treatment improvement accepted by the patient or care
Description
Number of proposal about treatment improvement agreed with primary care team in a face face meeting
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Molina-López, Pharm Dr
Phone
637642 411+
Email
mariat.molina.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Palma-Morgado, Pharm G
Email
daniel.palma.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Molina, Pharm Dr
Organizational Affiliation
Andalusian Health Service. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sevilla Primary Care District
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Molina-López, Pharm.Dr.
Phone
+34637642411
Email
mariat.molina.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Daniel Palma-Morgado, Pharm. Bch.
Email
daniel.palma.sspa@juntadeandalucia.es

12. IPD Sharing Statement

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

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