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

NCT06160102 | Active Not Recruiting

• 2 other identifiers: 22/658-6Project number: 341297
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disabilities, Intellectual; Disability, Developmental

Keywords

Intellectual Disabilities; Developmental Disabilities; Intersectoral Collaboration; Medication Therapy Management; Medication Reconciliation; Medication Review

Outcome Measures

Primary Outcomes (3)

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

  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.

  12 months

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

  Design thinking and co-creation of multidisciplinary frameworks

  18 months

• Explore usefulness of multidisciplinary frameworks

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

  18 months

Study Arms (1)

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

OTHER

Optimizing medication management and medication therapy poses complex challenges related to the different groups, actors, and not least the data systems. To meet these challenges, we have chosen a method where the participants contribute actively in the research: participatory action research (PAR). This method involves both the action and the knowledge production being done in collaboration between all the participants, since neither the researcher nor others have exclusive right to the understanding of reality. Normalization process theory offers an analytical tool that helps to understand and explain the dynamic processes that occur during the implementation of complex interventions and technological and organizational innovations in health care, which includes institutional and organizational contexts and focuses on what social processes can promote and inhibit it through the integration of new routines and work forms in established social structures.

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

Interventions

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.

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

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Vestvagoy Municipality: lead
• University of Oslo: collaborator
• University of Tromso: collaborator

Study Sites (1)

Vestvågøy Municipality

Leknes, 8370, Norway

Location

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Heidi Wiik, MBA

  Vestvågøy Municipality

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Science of Professions

Model Details: Participatory action research

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: December 7, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)