Implementation of a New Model of Care for Supporting Long-term Medication Adherence (Phase A)

NCT ID: NCT06191835

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-06-30

Brief Summary

The overall objective of the myCare Start-I project is to adapt, implement and evaluate the myCare Start service within the Swiss pharmacy-physician network to enhance medication adherence during the initiation of a new long-term treatment. The study will use an implementation science approach. The myCare Start service is based on the New Medicine Service (NMS) that was developed in the United Kingdom.

Detailed Description

Phase A:

1. To conduct a contextual analysis of the current Swiss primary care ecosystem as related to pharmacy-physician interprofessional health services for patients with long-term diseases (i.e., contextual analysis).

2. To engage key stakeholders within the Swiss primary care ecosystem to contribute to the co-creation of a Swiss interprofessional myCare Start service (i.e., stakeholder involvement).

3. To design a contextually adapted myCare Start for use within Swiss community practice using contextually appropriate implementation strategies (i.e., intervention development/selecting implementation strategies).

4. To conduct feasibility testing on the contextually adapted intervention and implementation strategies and to develop an implementation research logic model (i.e., feasibility testing).

Phase B: Please note Phase B will be carried out at a later date with further ethics committee approval.

5. To implement a contextually adapted Swiss myCare Start intervention in the pharmacy-physician network community and evaluate it in terms of medication adherence and cost-effectiveness outcomes.

6. To evaluate implementation outcomes and the implementation pathway of myCare Start.

Conditions

Medication Initiation for Long-term Conditions

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

myCare Start

The service consists of 2 times 10-minutes semi-structured pharmaceutical interventions between community pharmacist and patient, tailored to the patient's needs, positioned as partner, during the first 6 weeks after treatment initiation.

Intervention Type: BEHAVIORAL

Other Intervention Names

New Medicine Service

Eligibility Criteria

Inclusion Criteria

• Community pharmacists and technicians of 5 participating pharmacies in the French-speaking part of Switzerland and 5 in the German-speaking part of Switzerland
• Primary care physicians working in collaboration or in the neighbourhood of the participating pharmacies
• Patients with long-term treatments, who are a regular patients of the included pharmacies
• International research groups who have implemented NMS within their countries or similar interventions.

Exclusion Criteria

• Patients not willing to participate
• Patients that do not speak French or German

Phase B: hybrid type 2 effectiveness-implementation study

Patients are eligible for the myCare Start-I phase B study if :

• They are taking part in the myCare Start service
• They have been newly prescribed one or more new long-term medications in accordance with one of the five defined long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD))
• They are 18 years or older
• They have mandatory basic health insurance in Switzerland
• They are 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).
• They understand language spoken by pharmacy staff and are able to read and understand study documents (ge, fr)
• They are able to understand and willing to consent to the myCare Start study (including the agreement on self-reported questionnaires and collection of health care data via their health insurance company)

• 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).

myCare Start definition of a new medication:

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.

Operational definition of a new medication:

• Active ingredient is indicated for one of the five long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD)).
• Patient has never had this active ingredient dispensed before or restarts an active ingredient after a period of interruption of at least 12 months.

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 on inhalators for asthma/COPD)
• Intensification of dosage regimen (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 1000mg 1-0-0 instead of 500mg 1-0-1; change in antihypertensive drug regimen in elderly patients having vertigo in the morning: 0-0-X instead of X-0-0)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role: collaborator

pharmaSuisse, Switzerland

UNKNOWN

Sponsor Role: collaborator

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Marie Paule Schneider, PhD

Prof. Dr. Marie Paule Schneider

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Paule Schneider, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

Université de Genève

Geneva, Canton of Geneva, Switzerland

University of Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2023-01161

Identifier Type: -

Identifier Source: org_study_id