A Medication Plan for Safer Medication Treatment in Older Persons

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Safety
• Intervention / Treatment: Other: Medication plan

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Jönköping, Sweden, 55185
    • Region Jonkoping County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Medication Plan Prototype	Other: Medication plan; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention	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	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the medication plan	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.	Three months
Usability of the medication plan	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.	Three months
Patient safety	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.	Three months
Patient safety	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.	Three months
Acceptability of the intervention	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	Three months
Healthcare utilisation	Healthcare utilisation will be measured as number and cause, of hospital admission, emergency visits and unplanned physician visits during the follow up period	Three months

Collaborators and Investigators

• Sponsor: Region Jönköping County
• Collaborators: Jonkoping University
• Investigators: Principal Investigator: Malin Holmqvist, Region Jonkoping County

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: medication; primary care; feasibility study; aged
• Other Study ID Numbers: 2022-04430-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No