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

NCT06191835 | Active Not Recruiting

• 1 other identifier: 2023-01161
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Medication Initiation for Long-term Conditions

Keywords

medication adherence; medication initiation; long-term treatment; implementation science; interprofessional collaboration; outpatient care; community pharmacy; General practitioner; cost-effectiveness; medication adherence support programme

Outcome Measures

Primary Outcomes (5)

• Medication adherence (objective measure)

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

  6 - 12 months

• Medication adherence (subjective measure)

  Patient self-assessment (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.

  6 - 12 months

• 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

• 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.

  12 months

• Implementations Outcomes

  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.

  12 months

Interventions

myCare Start BEHAVIORAL

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.

Also known as: New Medicine Service

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase A: contextual analysis Community pharmacists and technicians General practitioners or internal medicine physicians Patients with a long-term treatment International research groups Phase B: effectiveness-implementation study Patients with a long-term treatment for five long-term conditions (cardiovascular disease (incl. hypertension and thromboprophylaxis), diabetes, hyperlipidaemia, depression and respiratory illness (asthma, COPD))

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Geneva, Switzerland: lead
• University of Basel: collaborator
• Fundació Sant Joan de Déu: collaborator
• pharmaSuisse, Switzerland: collaborator
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: collaborator
• University of Bern: collaborator

Study Sites (2)

Université de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

University of Basel

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marie Paule Schneider, PhD

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Marie Paule Schneider

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: January 5, 2024
• Study Start: August 30, 2023
• Primary Completion: January 16, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

CH (2)