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| Name | Class |
|---|---|
| University of Basel | OTHER |
| pharmaSuisse | UNKNOWN |
| Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Form 1 month prior to enrollement up to 12 months after enrollment of the patient in the study. |
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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:
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:
The following change is not considered as medication initiation:
Exclusion Criteria:
Physicians:
Inclusion criteria
- 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:
Inclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Marie Paule Schneider, Prof. PhD | Uinversity of Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Genève | Geneva | Canton of Geneva | 1211 | Switzerland |
Once fully anonymized, quantitative data will be annotated and structured to make them sharable, and registered in a FAIR-compliant data repository.
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| University of Bern |
| OTHER |
Randomised stepped wedge cluster design study
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| 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. |
| 12 months upon enrollment |
| 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. | Calculations will be conducted during the 12-month follow-up phase |
| Implementation Outcome: Acceptability | The AIM (=Acceptability of Intervention Measure) will be used. | - 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 | The IAM (=Intervention Appropriateness Measure) will be used. | - 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: Feasibility | The FIM (=Feasibility of Intervention Measure) will be used. | - 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 Outcomes: Implementation cost | 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. | Throughout the duration of the study - approximately 12 months |
| Implementation Outcomes: Adoption | 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). | Throughout the duration of the study - approximately 12 months |
| Implementation Outcomes: Fidelity | 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. | During the intervention phase of the pharmacies - approximately 12 months |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006949 | Hyperlipidemias |
| D010349 | Patient Compliance |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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