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

NCT05799430 | Unknown

• 1 other identifier: S0502
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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?

Conditions

Medication Review; Polypharmacy; Disease, Chronic

Keywords

Medication Review; Polypharmacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Healthcare utilisation

  12 months

• Mortality

  12 month

• Number of potentially inappropriate drugs

  12 months

• Number of medications

  12 months

• Number of proposal about treatment improvement

  7 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

The control group will receive usual care.

Behavioral: Control group

Interventions

Multidisciplinary medication review BEHAVIORAL

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

Intervention

Control group BEHAVIORAL

Usual care by FP an PCN

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Andalusian Health Service: collaborator

Study Sites (1)

Sevilla Primary Care District

Seville, 41013, Spain

RECRUITING

Related Publications (30)

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Related Links

• Estrategia para la seguridad del paciente. Plan estratégico de calidad del Sistema Sanitario Público de Andalucía. Consejería de Salud y Familias. 2019
• Lown Institute. Medication Overload: America's Other Drug Problem. How the drive to prescribe is harming older adults. 2019
• Scottish Government Polypharmacy Model of Care Group. Polypharmacy Guidance, Realistic Prescribing. 3ª edition, 2018. Scottish Government
• Medicines Optimization. Quality standard \[QS120\] NICE. 2016
• Atención a Pacientes Pluripatológicos. Proceso Asistencial Integrado. Consejería de Salud 2018.
• Plan Andaluz de Atención Integrada a Pacientes con Enfermedades Crónicas. Consejería de Salud. 2012

MeSH Terms

Conditions

Chronic Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Teresa Molina, Pharm Dr

  Andalusian Health Service. Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Molina-López, Pharm Dr

CONTACT

637642 411+; mariat.molina.sspa@juntadeandalucia.es

Daniel Palma-Morgado, Pharm G

CONTACT

daniel.palma.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster-randomized control trial

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 15, 2023
• Primary Completion: June 10, 2024
• Study Completion: July 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-04

Locations

ES (1)