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Active, Not Recruiting

NCT Number: NCT06160102

Appropriate Medication Use for Individuals With Intellectual Disabilities - A Matter of Life

The innovation idea is to develop valuable new knowledge about safe drug use in people with intellectual and/or developmental disabilities (IDDs). The main goal is to design a framework (routines and processes) that ensures safe drug use and provides qualitatively better services for people with IDDs. Secondary goals are that employees will experience better security when working with medicines, and interact better with people with IDD and relatives by implementing digital support functions. The innovation idea is specifically to develop/improve the following: 1) Medication management: Coordinating routines, procedures and work processes regarding all aspects of drug use, medication handling, and communication between care units for people with IDDs. 2) Medication therapy: Chart review of prescribed medication and gather knowledge about challenges related to drug use in this group. Based on this, we will develop new methods for drug reconciliation and medication reviews to optimize drug use. 3) New framework for safe drug use in the community-based services for people with IDDs.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Disabilities, Intellectual Developmental Disabilities Disability, Developmental Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestvågøy Municipality

Leknes, 8370, Norway

About this study

Changing, developing, and testing new routines, procedures, and communication methods for safe drug use is challenging. The complexity of systems that are involved in medication management makes it particularly challenging to create well-designed digital solutions that ensure good working procedures. The complex issues faced by people with IDDs, as well as developments within personalized medicine, means that it is crucial to build new knowledge, work in teams, and arrange for medication reconciliation and medication reviews to be carried out regularly. Furthermore, drug information must be provided, and adapted to the specific individual with an intellectual disability. In addition, the focus on personalized medicine means that the municipality must develop new guidelines for the use of pharmacogenetic tests so that the doctor can tailor drug selection and dosage to the individual patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Users of the municipality's Service for people with disabilities

Exclusion criteria

-

Treatment and study plan

Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilities

Other

Collection and analysis of drug lists and information about the users. Open / participatory observations of staff and residents during drug handling. Interviews/focus groups with residents, family, staff in the service, GPs and pharmacy staff. Interdisciplinary drug reviews based on the IMM method drug reviews, further developed by the researchers in the project.

Design thinking. We use a design process with five stages: empathy, define, generate ideas, prototype and test. This involves user participation and experience to design the most optimal solution for the framework.

Evaluate the framework, observations, interviews, questionnaires. Health economic evaluation.

Primary outcomes

  1. To understand what is safe drug therapy and drug handling in people with intellectual and/or developmental disabilities

    Time frame: 12 months

    Map which drugs each patient uses and carry out medication reconciliation (nurse and pharmacist) and medication review (nurse, pharmacist and general general practitioner).

    Interviews of employees, GPs and pharmacy staff.

  2. Formulation of multidisciplinary frameworks for optimizing drug handling and drug therapy.

    Time frame: 18 months

    Design thinking and co-creation of multidisciplinary frameworks

  3. Explore usefulness of multidisciplinary frameworks

    Time frame: 18 months

    Transcripts of qualitative feedback. Follow-up survey of employees, GPs, pharmacy staff, and people with intellectual and/or developmental disabilities. Health economic evaluation.

Sponsors and collaborators

Lead sponsor

Vestvagoy Municipality

Other

Collaborators

  • University of Oslo
  • University of Tromso

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 7, 2023
Registry last updated
Dec 4, 2025

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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