Multiple Chronic Conditions Clinical Trial
Official title:
Open Randomised Multicentric Controlled Trial to Evaluate the Impact of an Intervention to Improve Drug Appropriateness in Polymedicated Patients According to the Person-centered Care Model by a Multidisciplinary Team at Primary Care
NCT number | NCT04188470 |
Other study ID # | 19/144-P |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2020 |
Est. completion date | July 2023 |
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 9 primary healthcare team in Bages and Anoia (Catalonian region). Period: May 2020 and ends at 12 months of follow-up of the last included subject. Method: 9 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.
Status | Recruiting |
Enrollment | 33 |
Est. completion date | July 2023 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Subjects do not want participate at the study - <2 visits in the last year with the basic healthcare team - palliative care by PADES |
Country | Name | City | State |
---|---|---|---|
Spain | Mar Casanovas | Igualada | Barcelona |
Spain | Rovira | Manresa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Jordi Gol i Gurina Foundation |
Spain,
Bonaga B, Sánchez-Jurado PM, Martínez-Reig M, Ariza G, Rodríguez-Mañas 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. — View Citation
Campins L, Serra-Prat M, Gózalo I, López D, Palomera E, Agustí C, Cabré 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Rodriguez-Mañas L, Rodríguez-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. — View Citation
Saum KU, Schöttker 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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | average of medication changes | number of changes maked in the therapeutic plan of the patients | 6 and 12 months | |
Primary | average of hospitalizations | number of hospitalizations | 0 and 12 months | |
Secondary | Number of adverse events caudes by medication changes | Adverse events caused by the intervention defined as abstinence syndrome, rebound effects, worsening symptoms, medication errors, emergency visitors, hospital admissions, successes | 6 and 12 months | |
Secondary | Number of changes at the end of the study | Medication changes at th end of the study define as a reintroduction of a stopped medication during the intervention and/or introduction of a new medication | 6 and 12 months |
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