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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Geneva, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: Usual Care ArmNo intervention 0 interventions
Group B: myCare Start ArmExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Medication adherence (objective measure)

Prescription renewal records (objective measure): Medication renewal records will be extracted from health insurance data and analyzed using the "AdhereR" software in R.

Time frame
Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study.
2

Cost-effectiveness short-term

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.

Time frame
12 months upon enrollment
3

Cost-effectiveness long-term

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.

Time frame
Calculations will be conducted during the 12-month follow-up phase
4

Implementation Outcome: Acceptability

The AIM (=Acceptability of Intervention Measure) will be used.

Time frame
- 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.

Other outcomes

Sponsors and contacts

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University of Geneva, Switzerland

Lead sponsor

University of Basel

Collaborator

pharmaSuisse

Collaborator

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

Collaborator

University of Bern

Collaborator

This trial is not recruiting at the moment. You can still explore other options: