- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06160102
Safe Drug Use in People With Intellectual and/or Developmental Disabilities - it Applies to Life
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leknes, Norway, 8370
- Vestvågøy Municipality
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Users of the municipality's Service for people with disabilities
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Framework for safe drug use in people with intellectual and/or developmental disabilities
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 months
|
Formulation of multidisciplinary frameworks for optimizing drug handling and drug therapy.
Time Frame: 18 months
|
Design thinking and co-creation of multidisciplinary frameworks
|
18 months
|
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.
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Turid Amundsen, MD, Vestvågøy Municipality
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22/658-6
- Project number: 341297 (Other Grant/Funding Number: The Research Council of Norway)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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