Université de Genève
Geneva, Canton of Geneva, 1211, Switzerland
NCT Number: NCT07036471
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Geneva, Canton of Geneva, 1211, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients
Inclusion criteria
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:
Exclusion criteria
Physicians:
Inclusion criteria
Pharmacies:
Inclusion criteria
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.
Time frame: Surveys at 14 days, 6 weeks, 3, 6 and12 months upon enrollement.
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: Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study.
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: 12 months upon enrollment
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: Calculations will be conducted during the 12-month follow-up phase
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: - 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.
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.
The IAM (=Intervention Appropriateness 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.
The FIM (=Feasibility of Intervention Measure) will be used.
Time frame: Throughout the duration of the study - approximately 12 months
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.
Time frame: Throughout the duration of the study - approximately 12 months
Adoption is defined as "the intention, initial decision, or action to try or employ an innovation or evidence-based practice".
It will be measured through investigator onboarding logs and consultation records (No. of invited pharmacies and physicians, No. who completed training, No. who recruited or referred patients, No. of patients who participated in the intervention).
Time frame: During the intervention phase of the pharmacies - approximately 12 months
Fidelity is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol.
Consultation records (from the myCare Start consultations) and facilitation checklists will be used, to understand if the service is being carried out as intended and in appropriate areas.
Contact information is provided by the study sponsor or research team.
Marie Paule Schneider, Prof. PhD
CONTACT
Sarah Serhal, PhD
CONTACT
University of Geneva, Switzerland
Other
Evaluation of the myCare Start Service to Support Patients Starting a New Medicine in Switzerland: A Hybrid Type II Effectiveness-implementation Study
Acronym: myCare Start-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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