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Набор по приглашению NCT07283055

A Swiss Interprofessional Network for Reviewing Inappropriate Medication in Primary Care

Без фазы С лечением Medication Review Primary Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Medication review.
Кому может быть актуально
Состояния в реестре: Medication Review, Primary Care. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Swiss Interprofessional Network for Reviewing Inappropriate Medication in Primary Care: a Pilot Study

Обзор

The aim of the SINERGIC pilot study is to assess the feasibility in the Swiss context of implementing interprofessional medication reviews between GP and pharmacists, as part of a shared decision-making process with patients. The acceptability and potential effectiveness of such an intervention will also be assessed. This assessment will enable the investigators to take into account the determining factors for setting up a large-scale study to support the sustainable financing of this service in the long term.

Подробное описание

The ageing population is leading to an increase in the prevalence of chronic conditions among older adults, often resulting in excessive polypharmacy. Polypharmacy, as well as the prescription of high-risk medications in this population, exposes them to more adverse effects, which can lead to falls and hospitalisation. This problem is of concern to healthcare professionals, whether they be general practitioners (GP), who have an overview of medical records, or dispensing pharmacists, who have an overview of medication. In Switzerland, these two professions still operate often in isolation from each other, but genuine collaboration is essential if we are to improve and manage polypharmacy among the elderly and limit the risks. Medication reviews are recognised as promising strategies for improving the quality of prescribing in patients with multiple medications.

This pilot trial does not randomly select participants and does not include a control group. It is a hybrid study that aims both to test the effectiveness of the intervention and to prepare for its implementation.

The study plans to include at least 250 patients from three groups of general practices in different settings. Participants will be aged 65 or older, take at least five chronic medications, and suffer from at least three chronic conditions. Individuals living in medical institutions will not be included.

Intervention:

* Step 1 (optional): Patients taking at least 10 chronic medications and experiencing adherence or side effect issues may benefit from a specialised consultation with a pharmacist. * Step 2: The pharmacist identifies any medication-related issues for each patient and discusses them directly with the general practitioner in order to agree on the necessary adjustments. * Step 3: During a medical appointment, the doctor and patient will decide together whether to implement the proposed changes. * Step 4: The pharmacist will follow up after a few days and then again after 3 months.

Main objective: To assess whether this service is feasible in the context of the study.

Secondary objectives: Measure whether the intervention is well accepted (questionnaires and interviews) by the patients and healthcare professionals involved.

Exploratory objectives: Study the impact of the intervention on the quality of drug treatments, patients' quality of life and drug costs.

Вмешательства

  • Другое Medication review
    * Step 1 (optional): Patients taking at least 10 chronic medications and experiencing adherence or side effect issues may benefit from a specialised consultation with a pharmacist. * Step 2: The pharmacist identifies any medication-related issues for each patient and discusses them directly with the general practitioner in order to agree on the necessary adjustments. * Step 3: During a medical appointment, the doctor and patient will decide together whether to implement the proposed changes. * S

Первичные конечные точки

  • Number of participants recruited and percentage of participants retained [Срок оценки: End of the study, expected to be on average after 4-6 months]
  • Number of GPs recruited and percentage of GPs retained [Срок оценки: End of the study, expected to be on average after 18 months]
Вторичные конечные точки (7)
  • Score of participants' acceptability of the intervention (Patients Reported Experience Measures) [Срок оценки: End of the study, expected to be on average after 4-6 months]
  • Score of the healthcare professionals' acceptability of the intervention [Срок оценки: End of the study, up to 18 months]
  • Qualitative evaluation of healthcare professionals' acceptability [Срок оценки: End of the study, up to 18 months]
  • Number and percentage of clinically relevant drug related problems resolved [Срок оценки: 3 months after medical consultation]
  • Amount of drug cost savings [Срок оценки: 3 months after medical consultation]
  • Cost of the service [Срок оценки: During interprofessional meeting between GP and pharmacist]
  • Score on health-related quality of life (Patient-Reported Outcomes Measures or PROMs) [Срок оценки: 3 months after medical consultation]

Критерии участия

Критерии включения

  • Age ≥ 65 years old;
  • Regular use of at least 5 medications (chronic treatments, > 3 months);
  • Patients with a minimum of 3 chronic diseases;
  • Regular follow-up in a GP practice taking part in the project;
  • Adequate understanding of French.
  • Written informed consent

Критерии исключения

  • Residence in an institution (residential care facility, nursing home, etc.) ;
  • Cognitive impairment preventing understanding or obtaining informed consent;
  • Any other clinical situation deemed incompatible with participation, as decided by the GP in charge.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Швейцария · 1 центр
  • Institute of Primary Health Care (BIHAM) — Bern

Публикации

  • Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7. PMID 17630042
  • Liew TM, Lee CS, Goh SKL, Chang ZY. The prevalence and impact of potentially inappropriate prescribing among older persons in primary care settings: multilevel meta-analysis. Age Ageing. 2020 Jul 1;49(4):570-579. doi: 10.1093/ageing/afaa057. PMID 32365168
  • Cole JA, Goncalves-Bradley DC, Alqahtani M, Barry HE, Cadogan C, Rankin A, Patterson SM, Kerse N, Cardwell CR, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2023 Oct 11;10(10):CD008165. doi: 10.1002/14651858.CD008165.pub5. PMID 37818791

Идентификаторы

NCT: NCT07283055 · SINERGIC_01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗