Optimising Drug Therapy in Polymedicated Patients According to the Person-centered Care Model

NCT04188470 | Completed

• 1 other identifier: 19/144-P
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: In recent years, multi-aging has increased by 25%. This is related to plutipatology, frailty, polymedications, elevated sanitary cost, low quality of life, adverse events and mortality. To improve this it is necessary to apply the people-centered care model that includes and individualized therapeutic plan taking into account medication appropriateness, frailty, complexity and patient preferences. A collaborative model by a multidisciplinary team is proposed to make decisions to optimize drug therapy. Hypothesis: person-centered care model by a multidisciplinary team at primary care improve drug appropriateness in polymedicated elderly patients Material and Method: Design: Randomized (1:1), open-label, multicentre, parallel-arm clinical trial with 1-year follow-up. Study population: community-dwelling polymedicated (≥8 drugs) elderly (≥75 years old) people at 11 primary healthcare team in Bages, Osona and Anoia (Catalonian region). Period: May 2020 and ends at 12 months of follow-up of the last included subject. Method: 11 primary healthcare team will be randomized to control or intervention group, then volunteers basic healthcare team will participate in the study and they will be assigned to control or intervention group depending on which team they work, then the subjects assigned to theses basic healthcare teams that meet the inclusion criteria and not exclusion criteria will be selected and finally the informed consent of these will be obtained. In the intervention group the multidisciplinary work team comprised by the clinical pharmacist, expert collaborator doctor and the basic healthcare team will meet periodically to review subjects, a multidimensional review will be carried out by assessing the frailty, complexity, morbidity and the appropriateness drug therapy, if proposed changes in the therapeutic plan will have to be agreed with the patient taking into account their preferences. At 6 and 12 months or when their basic healthcare team requests it they will be reviewed again. In the control group the necessary study data collection will be carry out at the beginning and at 6 and 12 months, and the routine clinical practice in relation to the use of medication will be carried out. Measurements: variation of the mean of incidents (potencially prescription inadequate) per patient, variation of the number of prescribed drugs per patient, changes in the therapeutic plans implemented and variation of the number of hospitalizations.

Conditions

Multiple Chronic Conditions; End Stage Disease

Keywords

Polypharmacy; deprescriptions; patient-centered care; frail elderly; interprofessional relations; decision making

Outcome Measures

Primary Outcomes (4)

• average number ofdetected incidents

  Medication incidents defined as therapeutic duplicity, contraindications, security advice about a drug, avoidable medication, inadequate duration, combinations of anticholinergic drugs, medication not recommended in older people, inadequate dosage, drug more efficient, and medication not indicated.

  0 and 12 months

• average on number of drugs per patient

  number of chronic (\>1 month of treatment duration) drugs (excluded topic drugs, ophthalmic drugs, diapers and cure material) prescribed in the therapeutic plan of the patient

  0 and 12 months

• average of medication changes

  number of changes maked in the therapeutic plan of the patients

  6 and 12 months

• average of hospitalizations

  number of hospitalizations

  0 and 12 months

Secondary Outcomes (2)

• Number of adverse events caudes by medication changes

  6 and 12 months

• Number of changes at the end of the study

  6 and 12 months

Study Arms (2)

person-centered care model

EXPERIMENTAL

healthcare multidisciplinary team will review the appropriateness of medication by a person-centered care model and then the healtcare team will propose changes in the therapeutic plan to the patient or caregiver

Behavioral: person-centered care model

usual care

NO INTERVENTION

the healthcare team will practice usual care

Interventions

person-centered care model BEHAVIORAL

A multidisciplinary team (clinical pharmaceutical, expert physician on chronic management disease, and basic healthcare team) will review the frailty, complexity, the therapeutic goals of the patients to propose changes on the therapeutic plan to improve the appropriateness, these changes will we agreed with the patient or caregiver.

person-centered care model

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Polimedicated patients (\>7 drugs of \>1 month treatment duration, exclude topical drugs, ophtalmologic drugs, diaper and cure products)
• Multiple chronic conditions
• Advanced cronic disease with short life expectancy

You may not qualify if:

• Subjects do not want participate at the study
• \<2 visits in the last year with the basic healthcare team
• palliative care by PADES

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (2)

Mar Casanovas

Igualada, Barcelona, Spain

Location

Rovira

Manresa, Barcelona, Spain

Location

Related Publications (11)

• Rodriguez-Manas L, Rodriguez-Artalejo F, Sinclair AJ. The Third Transition: The Clinical Evolution Oriented to the Contemporary Older Patient. J Am Med Dir Assoc. 2017 Jan;18(1):8-9. doi: 10.1016/j.jamda.2016.10.005. Epub 2016 Nov 22. No abstract available.

  PMID: 27887892 BACKGROUND

• Campins L, Serra-Prat M, Gozalo I, Lopez D, Palomera E, Agusti C, Cabre M; REMEI Group. Randomized controlled trial of an intervention to improve drug appropriateness in community-dwelling polymedicated elderly people. Fam Pract. 2017 Feb;34(1):36-42. doi: 10.1093/fampra/cmw073. Epub 2016 Sep 7.

  PMID: 27605543 BACKGROUND

• Melzer D, Tavakoly B, Winder RE, Masoli JA, Henley WE, Ble A, Richards SH. Much more medicine for the oldest old: trends in UK electronic clinical records. Age Ageing. 2015 Jan;44(1):46-53. doi: 10.1093/ageing/afu113. Epub 2014 Aug 7.

  PMID: 25103030 BACKGROUND

• Yarnall AJ, Sayer AA, Clegg A, Rockwood K, Parker S, Hindle JV. New horizons in multimorbidity in older adults. Age Ageing. 2017 Nov 1;46(6):882-888. doi: 10.1093/ageing/afx150.

  PMID: 28985248 BACKGROUND

• Bonaga B, Sanchez-Jurado PM, Martinez-Reig M, Ariza G, Rodriguez-Manas L, Gnjidic D, Salvador T, Abizanda P. Frailty, Polypharmacy, and Health Outcomes in Older Adults: The Frailty and Dependence in Albacete Study. J Am Med Dir Assoc. 2018 Jan;19(1):46-52. doi: 10.1016/j.jamda.2017.07.008. Epub 2017 Sep 9.

  PMID: 28899661 BACKGROUND

• Onder G, Petrovic M, Tangiisuran B, Meinardi MC, Markito-Notenboom WP, Somers A, Rajkumar C, Bernabei R, van der Cammen TJ. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med. 2010 Jul 12;170(13):1142-8. doi: 10.1001/archinternmed.2010.153.

  PMID: 20625022 BACKGROUND

• Saum KU, Schottker B, Meid AD, Holleczek B, Haefeli WE, Hauer K, Brenner H. Is Polypharmacy Associated with Frailty in Older People? Results From the ESTHER Cohort Study. J Am Geriatr Soc. 2017 Feb;65(2):e27-e32. doi: 10.1111/jgs.14718. Epub 2016 Dec 26.

  PMID: 28024089 BACKGROUND

• Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, Cohen HJ, Feussner JR. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992 Oct;45(10):1045-51. doi: 10.1016/0895-4356(92)90144-c.

  PMID: 1474400 BACKGROUND

• Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.

  PMID: 17630041 BACKGROUND

• Rovira C, Casanovas M, Vizcaino E, Massanes M, Miro Q, Sola L, Gallego J, Armengol J, Ayala C, Pascual J, Marino EL, Vidal-Alaball J, Modamio P; PCMR Study Group. Effectiveness of person-centred versus usual care in elderly patients: findings from a multicentre randomised controlled trial. J Pharm Policy Pract. 2026 Jan 19;19(1):2609020. doi: 10.1080/20523211.2025.2609020. eCollection 2026.

  PMID: 41567179 DERIVED

• Rovira C, Modamio P, Pascual J, Armengol J, Ayala C, Gallego J, Marino EL, Ramirez A; PCMR (Person-Centred Medication Review) Study Group. Person-centred care provided by a multidisciplinary primary care team to improve therapeutic adequacy in polymedicated elderly patients (PCMR): randomised controlled trial protocol. BMJ Open. 2022 Feb 9;12(2):e051238. doi: 10.1136/bmjopen-2021-051238.

  PMID: 35140146 DERIVED

Related Links

• demographic data of catalonian population
• a guideline about drug selection at nursery homes
• document with definitions about chronic conditions
• document of catalonian health department about safe use of drugs
• medication safe national institute
• recommendations about clinical assessment and management in multimorbidity condition

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

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

Study Officials

• Carol Rovira

  ICS

  PRINCIPAL INVESTIGATOR

• Joan Armengol

  ICS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 6, 2019
• Study Start: May 15, 2020
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)