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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Phase A: contextual analysis
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)
Exclusion criteria:
• 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)
Primary outcome measure(s)
Medication adherence (objective measure) — 6 - 12 months Prescription renewal records (objective measure):
Medication renewal records will be extracted from pharmaceutical records and analyzed using the "AdhereR" software in R.
Cost-effectiveness short-term — 12 months Total healthcare utilisation, in terms of total costs per patient, will be evaluated over the duration of the myCare Start follow-up period (12 months) using health insurance data. This will be combined with adherence results to determine the incremental cost-effectiveness ratio between the total costs per patient in the intervention vs. the control groups and the difference in adherence between groups. The survey will be forwarded to the patient at 14 days, 6 months, and 12 months after inclusion into the study via an emailed online survey.
The main analysis consists of calculating 1) the incremental cost-effectiveness ratio between the total costs per patient in the intervention vs. the control group and 2.) the difference in adherence between groups and the probability that the intervention is cost-effective when the willingness to pay varies (i.e. the cost-effectiveness acceptability curve), the two classic indicators of cost-effectiveness analyses of health programmes.
Cost-effectiveness long-term — 12 months Long-term potential healthcare cost savings will be evaluated using Markov Modelling. The Markov Modelling approach applied in this study is an adapted version of the models previously used in the UK to evaluate the New Medicine Service, adjusted with parameters tailored to the Swiss context. This approach will enable the projection and estimation of medium- and long-term benefits arising from improved adherence to the prescriptions as a result of the myCare start intervention. In Switzerland, the most commonly prescribed medications for long-term illnesses include cholesterol-lowering therapies, type 2 diabetes drugs, hypertension treatments, and antidepressants. For these four medication groups, specific Markov models have been developed. These calculations will be conducted during the 12-month longitudinal follow-up phase.
Implementations Outcomes — 12 months The myCare start service will be evaluated in terms of acceptability, adoption, appropriateness, fidelity, feasibility, and implementation cost as proposed by Proctor's Implementation Outcomes Taxonomy (Proctor et al., 2019).
Cost of implementation will be assessed using the time-driven activity-based cost (TDABC) instrument. This pragmatic method allows investigators to systematically estimate the cost of implementation strategies (e.g. training, reorganisation of practice, regular stakeholder meetings) and the cost of the intervention.
Trial sites (2)
Facility
City
Region
Status
Université de Genève
Geneva
Canton of Geneva
University of Basel
Basel
Switzerland
More University of Geneva, Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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