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

NCT07036471 | Not Yet Recruiting

• 1 other identifier: 2025-00715
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardio-vascular Disease; Depression Disorders; Diabetes; COPD; Asthma Bronchiale; Hyperlipidaemia; Medication Initiation for Long-term Conditions

Keywords

patient adherence; medication adherence; medication initiation; long-term treatment; implementation science; interprofessional collaboration; outpatient care; community pharmacy; general practitioner; cost-effectiveness; medication adherence support programme

Outcome Measures

Primary Outcomes (1)

• Medication adherence (subjective measure)

  Patient self-reported (subjective measure): We will use the BAASIS© (Basel Assessment of Adherence to Immunosuppressive Medications Scale), a 6-item scale with demonstrated psychometric properties in transplantation and other chronic diseases, as it assesses adherence according to the ABC taxonomy (Initiation, Medication Implementation, and Persistence). The BAASIS scale has a minimum and maximum value of 6 and 30, respectively. Lower scores on the BAASIS indicate poorer adherence to immunosuppressive medications, while higher scores indicate better adherence. This self-report instrument consists of six items that assess different aspects of medication adherence, including dose taking, drug holidays, timing deviation, reduction of dose, persistence, and timing of dose taking.

  Surveys at 14 days, 6 weeks, 3, 6 and12 months upon enrollement.

Secondary Outcomes (9)

• Medication adherence (objective measure)

  Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study.

• Cost-effectiveness short-term

  12 months upon enrollment

• Cost-effectiveness long-term

  Calculations will be conducted during the 12-month follow-up phase

• Implementation Outcome: Acceptability

  - 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

  - 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.

Study Arms (2)

Usual Care Arm

NO INTERVENTION

In the Usual Care Arm, the patients will receive the usual care from their pharmacist after being prescribed a new long-term medication.

myCare Start Arm

EXPERIMENTAL

In the myCare Start Arm, the patients will receive the myCare Start service in their pharmacy after being prescribed a new long-term medication. myCare Start is an interprofessional health service offered by community pharmacies in Switzerland to support medication adherence in patients starting a new long-term treatment. It 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.

Behavioral: myCare Start

Interventions

myCare Start BEHAVIORAL

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.

myCare Start Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• \- 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:
• 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.

Sponsors & Collaborators

• University of Geneva, Switzerland: lead
• University of Basel: collaborator
• pharmaSuisse: collaborator
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: collaborator
• University of Bern: collaborator

Study Sites (1)

Université de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Hyperlipidemias; Patient Compliance; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marie Paule Schneider, Prof. PhD

  Uinversity of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule Schneider, Prof. PhD

CONTACT

+41 22 379 53 16; marie.schneider@unige.ch

Sarah Serhal, PhD

CONTACT

+41 22 379 11 97; sarah.serhal@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Marie Paule Schneider

Model Details: Randomised stepped wedge cluster design study

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-04

Locations

CH (1)