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NCT Number: NCT06016140

A Medication Plan for Safer Medication Treatment in Older Persons

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.

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Key information

Conditions

Patient Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Jonkoping County

Jönköping, 55185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication plan

Other

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

Primary outcomes

  1. Feasibility of the intervention

    Time frame: Three months

    For 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 outcomes

  1. Usability of the medication plan

    Time frame: Three months

    A 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.

  2. Usability of the medication plan

    Time frame: Three months

    Semi-structured interviews, with questions addressing usability will be conducted with participants (older persons, next-of-kin, physicians, nurses) at the end of the three-month follow-up period. The interview guide will be guided by topics addressed in SUS. A strategic selection of all participants will be used to gather different experiences. The interviews will be audio-recorded and then will be transcribed verbatim.

  3. Patient safety

    Time frame: Three months

    We 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.

  4. Patient safety

    Time frame: Three months

    We will complement the questionnaire with semi-structured interviews performed with older persons, nurses, next-of-kin and physicians. Questions addressing patient safety will be asked to the same population and at the same occasion as the interviews about usability. The interview guide will be guided by questions in the Swedish National Patient survey and inspired by indicators for safety monitoring in healthcare as proposed by Vincent et al.

  5. Acceptability of the intervention

    Time frame: Three months

    Acceptability 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

  6. Healthcare utilisation

    Time frame: Three months

    Healthcare utilisation will be measured as number and cause, of hospital admission, emergency visits and unplanned physician visits during the follow up period

Sponsors and collaborators

Lead sponsor

Region Jönköping County

Other Gov

Collaborators

  • Jonkoping University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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