Clinical trial NCT06016140: A Medication Plan for Safer Medication Treatment in Older Persons
Official title: Applying a Medication Plan for Safer Medication Treatment in Older Persons - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety
Keywords: aged
medication
feasibility study
primary care
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Jonkoping University
First posted: 2023-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Harm from medications is still a concern in an aged population. As medication treatment for older persons many times are complex, a feasibility study can be helpful to support decisions about future evaluation and implementation of an intervention.

In this study, the overall aim is to assess feasibility, acceptability and potential effects of usage of a co-designed medication plan for older persons with medication treatment.

The study will take place in the primary care setting in Sweden, and involve persons 75 years or older using five or more medications on daily basis, physicians at primary care centers and persons supporting the older person in their medication use a home.

During an appointment, the physician and older person will agree on a medication plan, that will be documented in the older person's electronic health record and printed out on paper.

After three month, the potential outcomes of a medication plan will be collected, together with data about feasibility and acceptability of the intervention. Two questionnaires will be used, addressing usability and patient safety. Moreover, remote interviews with participants will be performed to address usability and patient safety. Information about the medication plan will be collected from the electronic health record. Data analysis will be done with descriptive statistics and qualitative content analysis.

Expected outcomes are an assessment of feasibility and acceptability, and potential outcomes, to support decision on a future evaluation of the medication plan.


Eligibility criteria: Inclusion Criteria:

* Physicians and nurses: regular contact with the older person regarding medications, employment at a primary care center and ability to understand and communicate in Swedish
* Older persons: age \>75 years old, five or more medications on a regular basis and ability to understand and communicate in Swedish
* Next-of-kin: age \> 18 years old, regular contact with the older person regarding medications, ability to understand and communicate in Swedish

Exclusion Criteria:

* Older persons: impaired cognitive ability affecting the ability to provide informed consent (Diagnosis code for dementia) and late palliative phase, here defined as estimated life expectancy shorter than six months
* Next-of-kin: impaired cognitive ability affecting the ability to provide informed consent

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Three months
Secondary outcomes:
measure: Usability of the medication plan
timeFrame: Three months
measure: Usability of the medication plan
timeFrame: Three months
measure: Patient safety
timeFrame: Three months
measure: Patient safety
timeFrame: Three months
measure: Acceptability of the intervention
timeFrame: Three months
measure: Healthcare utilisation
timeFrame: Three months
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Region Jonkoping County
Study officials:
affiliation: Region Jönköping County
name: Malin Holmqvist
role: PRINCIPAL_INVESTIGATOR
References: