Clinical trial NCT06191835: Implementation of a New Model of Care for Supporting Long-term Medication Adherence (Phase A)
Official title: Implementation of a New Model of Care for Supporting Adherence in People Starting a New Medication for a Long-term Condition (myCare Start-I Project) - An Implementation Science Study - Phase A
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Fundació Sant Joan de Déu
name: pharmaSuisse, Switzerland
name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: University of Bern
First posted: 2024-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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))

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.

Detailed description: Phase A:

1. To conduct a contextual analysis of the current Swiss primary care ecosystem as related to pharmacy-physician interprofessional health services for patients with long-term diseases (i.e., contextual analysis).
2. To engage key stakeholders within the Swiss primary care ecosystem to contribute to the co-creation of a Swiss interprofessional myCare Start service (i.e., stakeholder involvement).
3. To design a contextually adapted myCare Start for use within Swiss community practice using contextually appropriate implementation strategies (i.e., intervention development/selecting implementation strategies).
4. To conduct feasibility testing on the contextually adapted intervention and implementation strategies and to develop an implementation research logic model (i.e., feasibility testing).

   Phase B: Please note Phase B will be carried out at a later date with further ethics committee approval.
5. To implement a contextually adapted Swiss myCare Start intervention in the pharmacy-physician network community and evaluate it in terms of medication adherence and cost-effectiveness outcomes.
6. To evaluate implementation outcomes and the implementation pathway of myCare Start.

Eligibility criteria: 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 outcomes:
measure: Medication adherence (objective measure)
timeFrame: 6 - 12 months
measure: Medication adherence (subjective measure)
timeFrame: 6 - 12 months
measure: Cost-effectiveness short-term
timeFrame: 12 months
measure: Cost-effectiveness long-term
timeFrame: 12 months
measure: Implementations Outcomes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
city: Geneva
country: Switzerland
facility: Université de Genève
Study officials:
affiliation: University of Geneva
name: Marie Paule Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
References: