NCT06016140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

June 20, 2023

Last Update Submit

January 8, 2024

Conditions

Keywords

agedmedicationfeasibility studyprimary care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Usability of the medication plan

    Three months

  • Usability of the medication plan

    Three months

  • Patient safety

    Three months

  • Patient safety

    Three months

  • Acceptability of the intervention

    Three months

  • +1 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

Medication Plan Prototype

Other: 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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Jonkoping County

Jönköping, 55185, Sweden

Location

Related Publications (1)

  • Holmqvist M, Ros A, Thor J, Johansson L. Applying a co-designed medication plan for safer medication treatment in older persons: a feasibility study. Pilot Feasibility Stud. 2025 Jul 3;11(1):92. doi: 10.1186/s40814-025-01661-1.

Study Officials

  • Malin Holmqvist

    Region Jönköping County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, pharmacist

Study Record Dates

First Submitted

June 20, 2023

First Posted

August 29, 2023

Study Start

June 1, 2022

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations