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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
First received
Last updated
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
Health authority
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: -

Study Design


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
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