Supporting Patients Starting New Medicines: Evaluating the myCare Start Service in Switzerland

Официальное название

Evaluation of the myCare Start Service to Support Patients Starting a New Medicine in Switzerland: A Hybrid Type II Effectiveness-implementation Study

Обзор

In Phase B, the aim is to evaluate the myCare Start service in routine care within the ambulatory primary care medicine and community pharmacy setting in Switzerland. A Type II hybrid effectiveness-implementation study will be conducted to evaluate the effectiveness (improvement in adherence), cost-effectiveness and implementation of the service. This evaluation will allow us to build the necessary contextual relevant evidence base to support sustainable funding of the service in the long term.

Подробное описание

In Switzerland, almost half of the population has a long-term condition. Non-adherence to essential medication to treat these long-term conditions leads to suboptimal patient outcomes, increased hospitalisations, mortality, and financial burden to patients and healthcare systems. Innovative ways to address patient adherence within the ambulatory primary care medicine and community pharmacy setting in Switzerland are needed. Based on the UK New Medicine Service (NMS), pharmaSuisse introduced myCare Start into community pharmacy practice in Switzerland. However, like in other international settings barriers were experienced limiting its uptake and impact highlighting the need for context-based adaptation when the service is implemented in new settings. The myCare Start Implementation project (myCare Start-I) is a biphasic project to assist in optimising fit of the myCare Start service for Switzerland (Phase A) and evaluate its impact (Phase B). In Phase A, which is now complete, using implementation science methods, researchers conducted a thorough contextual analysis of the Swiss primary care ecosystem and adapted the existing myCare Start model using an iterative co-creation process with stakeholders to suit the needs of the primary care context. In Phase B a Type II hybrid effectiveness-implementation study will be conducted to evaluate the effectiveness (improvement in adherence), cost-effectiveness and implementation of the service to build the necessary evidence base to support sustainable funding of the service in the long term.

Вмешательства

• Поведенческое myCare Start
  The service consists of two 10-minute, semi-structured and tailored consultations delivered by community pharmacists during the first 6 weeks of a patient initiating a new long-term medication, followed by tailored feedback to the patient's physician.

Первичные конечные точки

• Medication adherence (subjective measure) [Срок оценки: Surveys at 14 days, 6 weeks, 3, 6 and12 months upon enrollement.]

Вторичные конечные точки (9)

• Medication adherence (objective measure) [Срок оценки: Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study.]
• Cost-effectiveness short-term [Срок оценки: 12 months upon enrollment]
• Cost-effectiveness long-term [Срок оценки: Calculations will be conducted during the 12-month follow-up phase]
• Implementation Outcome: Acceptability [Срок оценки: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.]
• Implementation Outcome: Appropriateness [Срок оценки: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.]
• Implementation Outcome: Feasibility [Срок оценки: - Every 2 months during the intervention phase of the study (for pharmacies and physicians) - at 2 & 6 weeks, 3, 6 and 12 months upon inclusion for intervention patient.]
• Implementation Outcomes: Implementation cost [Срок оценки: Throughout the duration of the study - approximately 12 months]
• Implementation Outcomes: Adoption [Срок оценки: Throughout the duration of the study - approximately 12 months]
• Implementation Outcomes: Fidelity [Срок оценки: During the intervention phase of the pharmacies - approximately 12 months]

Критерии участия

Patients

Критерии включения

• Must have mandatory basic health insurance in Switzerland
• Must have been newly prescribed one or more new long-term medications in accordance with the following chronic conditions: cadisovascular diseases (incl. hyertension and thromboprophylaxis), diabetes, hyperlipidemia, depression, respiratory illness (asthma and COPD)
• Must be able to self-manage treatment (i.e. they live at home without any support to manage their medication, exception: patient uses a pill dispenser and fills it in by him-/herself)
• Must be able to understand language spoken by pharmacy staff and can read and understand study documents (French, German, English)
• Must understand and are willing to consent to the myCare Start-I study (including the agreement on self-reported questionnaires and collection of health care data via their health insurance company)
• in the intervention arm, patients must receive the myCare Start service

For this study, a new medication is a medication that has not been previously dispensed to the patient. This includes one or more new medications for a new diagnosis and or new medications for pre-existing diagnosis of a long-term condition. Included in this working definition:

• The new medication is indicated for one of the five long-term diseases listed above
• Patient has never had this active ingredient dispensed before (patient still considered eligible if they have received a small initial sample pack from their physician) or restarts an active ingredient after a period of interruption of at least 12 months (time period to be reported by the patient). Please note that for patients, that have already started a sample pack of medication the myCare Start Consultation One can start upon first dispensation at the pharmacy, there is no need to wait 7-14 days.
• The new active ingredient can be part of a combo preparation (e.g. a diuretic added to an ACE inhibitor into the same preparation)
• Patient has had no change in active ingredient but has an important change in treatment administration, such as:

• Change of galenic form (e.g. two different types of inhalators for asthma/COPD)
• Intensification of dosage regiment (e.g. twice a day instead of once a day)
• The following change is not considered as medication initiation:

• New dosage of already known active ingredient (e.g. dose escalation of antidepressants)
• Simplification of administration mode (e.g. metformin 1000 mg 1-0-0 instead of 500 mg 1-0-1; change in antihypertensive drug regiment in elderly patients having vertigo in the morning: 0-0-X instead of X-0-0)

Критерии исключения

• Patients participating or having participated in an education program about their disease or treatment in the last 3 months, led by healthcare providers such as physicians, nurses, pharmacists or other (e.g. education provided by nurses for type I diabetes patients)

Physicians:

Критерии включения

\- Any physician treating a patient for one of the five long-term illnesses listed above is eligible to refer the patient to a pharmacy providing myCare start.

Pharmacies:

Критерии включения

• Have to be enrolled into the myCare Start service and comply to the requirements of the pharmacy quality system management of having access to a private consultation room or area
• Must agree to participate in the research study, including the recruitment of control patients and the delivery of the myCare Start service to intervention patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Швейцария · 1 центр

• Université de Genève — Geneva

Идентификаторы

NCT: NCT07036471 · 2025-00715

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗