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Completed

NCT Number: NCT05094986

Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence

This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.

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Key information

Conditions

Adherence, Medication Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Cornellà de Llobregat (La Gavarra), Cornellà de Llobregat, Barcelona, Spain

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About this study

A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC).

The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients.

The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary healthcare professionals and pharmacists who:

  • Agree to participate in the pilot study.

Primary care patients who:

  • Are prescribed a new treatment of cardiovascular disease o diabetes by a GP who participates in the clinical trial.
  • Are >18 years old.
  • Do not reject to participate.

Treatment and study plan

Initial Medication Adherence (IMA) Intervention

Behavioral

The IMA intervention promotes health literacy and patient participation in the decision-making process during the recommendation and prescription of a new drug for the management of cardiovascular disease and diabetes. The IMA intervention has four main components: 1. Training for healthcare professionals (GPs, nurses, and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; 2. Intervention support tools; decision aids (leaflets and website) and implementation tools (dispensing alert in community pharmacies when dispensing insulins and antiplatelet drugs); 3. Shared decision-making process during the GP's consultation; and 4. Information support provided by the nurses and community pharmacists that use the intervention decision aids to explore the patients' doubts and standardise the discourse between primary healthcare professionals.

Usual Care

Other

Patients received the usual care when being prescribed a new prescription for treatments of cardiovascular disease or diabetes. Nurses and community pharmacists were asked to also provide usual care to those patients. Community pharmacists from the control group had the dispensing alert available when dispensing insulins and antiplatelet drugs.

Primary outcomes

  1. Rate of clinical registries related to diabetes mellitus II

    Time frame: 5 months before and after recruitment

    Rate of registries recorded five months before and after the prescription of:

    • Glycated haemoglobin
    • Glomerular filtrate
    • Blood glucose

  2. Rate of clinical registries related to dyslipidemia

    Time frame: 5 months before and after recruitment

    Rate of registries recorded five months before and after the prescription of:

    • Total colesterol
    • HDL cholesterol
    • LDL colesterol

  3. Rate of clinical registries related to hypertension

    Time frame: 2 months before and after recruitment

    Rate of registries recorded one to two months before and after the prescription of:

    • Systolic blood pressure
    • Diastolic blood pressure

  4. Rate of clinical registries related to cardiovascular risk

    Time frame: 5 months before and after recruitment

    Rate of registries recorded five months before and after the prescription of:

    • REGICOR

  5. Rate of use of services

    Time frame: 5 months before and after recruitment

    Rate of use of services recorded five months before and after the prescription of:

    • Visits to primary care (nurse, GP)
    • Referrals to secondary care
    • Productivity losses (sick leave days)
    • Outpatient diagnostic tests

Secondary outcomes

  1. Active diagnosis registry

    Time frame: 5 months before and after recruitment

    Proportion of patients with a new prescription of cardiovascular disease and diabetes treatments and an active diagnosis in the electronic system.

  2. Missing registries

    Time frame: 5 months before and after recruitment

    Number of registries missing.

  3. Outliers registries

    Time frame: 5 months before and after recruitment

    Number of registries with values out of their range.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • CIBER of Epidemiology and Public Health
  • Col·legi de Farmacèutics de la Província de Barcelona
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Institut Català de la Salut
  • Parc Sanitari Sant Joan de Déu

Registry information

Official study title

Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2021
Registry last updated
Feb 18, 2022

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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