Safe Drug Use in People With Intellectual and/or Developmental Disabilities - it Applies to Life

Disability, Developmental Clinical Trial

Official title:

Safe Drug Use in People With Intellectual and/or Developmental Disabilities - it Applies to Life

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06160102
• Other study ID #: 22/658-6
• Secondary ID: Project number:
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: November 2023
• Source: Vestvagoy Municipality
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

Inclusion Criteria:

• Users of the municipality's Service for people with disabilities Exclusion Criteria: -

Related Conditions & MeSH terms

• Developmental Disabilities
• Disability, Developmental
• Intellectual Disability

Intervention

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

Locations

Country	Name	City	State
Norway	Vestvågøy Municipality	Leknes

Sponsors (3)

Lead Sponsor	Collaborator
Vestvagoy Municipality	University of Oslo, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Formulation of multidisciplinary frameworks for optimizing drug handling and drug therapy.	Design thinking and co-creation of multidisciplinary frameworks	18 months
Primary	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