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A Medication Plan for Safer Medication Treatment in Older Persons

Applying a Medication Plan for Safer Medication Treatment in Older Persons - a Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06016140
Enrollment
30
Registered
2023-08-29
Start date
2022-06-01
Completion date
2023-11-01
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Safety

Keywords

aged, medication, feasibility study, primary care

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.

Interventions

Involved participants will jointly agreed on continued medication treatment (treatment aim, planned monitring and evaluation and responsibility, and the physician will document the plan in the electronic health record

Sponsors

Jonkoping University
CollaboratorOTHER
Region Jönköping County
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the interventionThree monthsFor feasibility of the intervention, the secondary outcome measures will be analyzed together to address the feasibility of chosen study methods and of the intervention of using a co-designed medication plan

Secondary

MeasureTime frameDescription
Usability of the medication planThree monthsA modified version of Brookes The System Usability Scale, SUS will be used to measure usability of the medication plan. SUS is a widely used questionnaire for measuring the perception of the user experience and has been translated and evaluated in Swedish. The questions will be distributed by e-mail or mail (which is preferred of the participants) at the end of the three-month follow-up period.
Patient safetyThree monthsWe will use a selected number of questions, which addresses concerns related to safety, from the Swedish National Patient survey in primary care, and ask the older persons to complete the questionnaire. No similar measurement will be used for healthcare professionals and next-of-kin.
Acceptability of the interventionThree monthsAcceptability of the intervention will be assessed by collecting the number of completed and adjusted medication plans, the content in the medication plans and medications prescribed for each older person during the follow up period
Healthcare utilisationThree monthsHealthcare utilisation will be measured as number and cause, of hospital admission, emergency visits and unplanned physician visits during the follow up period

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026