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

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799430
• Other study ID #: S0502
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Teresa Molina-López, Pharm Dr
• Phone: 637642 411+
• Email: mariat.molina.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 372
• Est. completion date: July 31, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Disease, Chronic
• Medication Review
• Polypharmacy

Intervention

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
• Control group
Usual care by FP an PCN

Locations

Country	Name	City	State
Spain	Sevilla Primary Care District	Sevilla

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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Nieto-Martin MD, De la Higuera-Vila L, Bernabeu-Wittel M, Gonzalez-Benitez MA, Alfaro-Lara ER, Baron-Ramos MA, Montero-Aparicio E, Aparicio-Santos R, Baturone MO; list of researchers involved in the IMPACTO study and their affiliations. A multidisciplinary approach for patients with multiple chronic conditions: IMPACTO study. Med Clin (Barc). 2019 Aug 2;153(3):93-99. doi: 10.1016/j.medcli.2019.01.014. Epub 2019 Mar 8. English, Spanish. — View Citation

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Rodriguez-Perez A, Alfaro-Lara ER, Sierra-Torres MI, Villalba-Moreno A, Nieto-Martin MD, Galvan-Banqueri M, Santos-Ramos B. Validation of the LESS-CHRON criteria: reliability study of a tool for deprescribing in patients with multimorbidity. Eur J Hosp Pharm. 2019 Nov;26(6):334-338. doi: 10.1136/ejhpharm-2017-001476. Epub 2018 May 30. — View Citation

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Santos-Ramos B, Otero Lopez MJ, Galvan-Banqueri M, Alfaro-Lara ER, Vega-Coca MD, Nieto-Martin MD, Ollero-Baturone M. [Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy/the hospital pharmacist]. Farm Hosp. 2012 Nov-Dec;36(6):506-17. doi: 10.7399/FH.2012.36.6.52. Spanish. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospitalization episodes	Registered in Electronic Health Record. In emergency department or in hospital service	12 months
Primary	Length of Hospital Stay	Registered in Electronic Health Record.	12 months
Secondary	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
Secondary	Mortality	Dead for any cause	12 month
Secondary	Number of potentially inappropriate drugs	Total number of potentially inappropriate prescribed drugs based on explicit criteria	12 months
Secondary	Number of medications	Total number of drugs chronically prescribed (treatment length: unless 120 days)	12 months
Secondary	Number of proposal about treatment improvement	Number of proposal about treatment improvement included in PCP report	7 days
Secondary	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
Secondary	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

External Links

•   Atención a Pacientes Pluripatológicos. Proceso Asistencial Integrado. Consejería de Salud 2018.
•   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
•   Marco Estratégico para la Atención Primaria y Comunitaria. Ministerio de Sanidad. Ministerio de Sanidad, Consumo y Bienestar Social. Madrid. 2019.
•   Medicines Optimization. Quality standard [QS120] NICE. 2016
•   Plan Andaluz de Atención Integrada a Pacientes con Enfermedades Crónicas. Consejería de Salud. 2012
•   Recomendaciones de prácticas seguras en la conciliación al alta hospitalaria. Ministerio de Sanidad, Consumo y Bienestar Social. Madrid. 2019
•   Scottish Government Polypharmacy Model of Care Group. Polypharmacy Guidance, Realistic Prescribing. 3ª edition, 2018. Scottish Government