Patient SafetyNCT06016140
A Medication Plan for Safer Medication Treatment in Older Persons
A study testing Medication plan in people with Patient Safety, run by Region Jönköping County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety
- What is being tested?
- Medication plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Patient Safety
- Being tested
- Medication plan
- Keywords
- aged, medication, feasibility study, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication planOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Medication Plan Prototype Receives: Other: Medication plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jun 2022
- Primary completion1 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Jonkoping University
- Responsible party
- Principal investigator, Malin Holmqvist, Region Jönköping County
- Investigators
- Malin Holmqvist, Principal investigator, Region Jönköping County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016140
- Sponsor's protocol ID
- 2022-04430-01
- Status last verified
- Jan 2024
- First submitted
- 20 Jun 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40611301
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying a Medication Plan for Safer Medication Treatment in Older Persons - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06016140
- Acronym / sponsor ID
- 2022-04430-01
- Conditions
- Patient Safety
- Keywords
- aged, medication, feasibility study, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Jonkoping University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Medication planMedication Plan Prototype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication planInvolved 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 | Other | Intervention group |
Primary outcome
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
6 secondary outcomes
Usability of the medication plan
Time frame: Three months
Usability of the medication plan
Time frame: Three months
Patient safety
Time frame: Three months
Patient safety
Time frame: Three months
Acceptability of the intervention
Time frame: Three months
Healthcare utilisation
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 40611301Holmqvist 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malin Holmqvist principal investigator
Region Jönköping County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication plan in people with Patient Safety, run by Region Jönköping County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.