Polypharmacy PatientsNCT04945447
Improving Medication Reviews to Polypharmacy Patients
A study testing Systematic pharmacist intervention in people with Polypharmacy Patients and Pharmacist Intervention, run by Aalborg University at 1 site in Denmark.
Trial summary
Brief summary: The randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypharmacy Patients, Pharmacist Intervention
- What is being tested?
- Systematic pharmacist intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Jan 2025
- 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
- Patients with more than 5 medicinal products prescribed besides skin remedies and antibiotic
- Above 18 years
- Patients in continuous medication treatment
Who cannot join
- Terminal patients
- Patients who are not motivated to comply with the instruction of the trial
- Do not speak/or understand written Danish
- Patients lacking legal capacity
- Patients living at nursing homes
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
The quality unit for genreal practice
Aalborg, North Denmark
Jesper Søndergaard, MsC, +4599403527, jhsxn@dcm.aau.dk
About this study
Official title: Effects of a Pharmacist Intervention in the Primary Sector on Patients Medication and Health-related Quality of Life: A Randomised Controlled Trial
Brief summary: The randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. The purpose is to gain more knowledge to patients and physicians about their medication and to see changes in the patient's medication and health-related quality of life.
Read the detailed description
The main objective of the randomised controlled trial is to investigate the clinical effects of the roll-out of the systematic offer from Nord-KAP in the North Denmark Region at two different levels (medical clinic and patient-level). The primary outcome is changes in the participant's medicine from baseline to follow up and changes in healthcare usage Secondary outcomes include investigation of cost-effectiveness and changes in patients health-related quality of life.
The hypothesis is that the regional intervention delivered by the pharmacists, from Nord-KAP, can lead to a decrease in medical products compared with a control group between baseline and at 6-month follow-up.
- Will the use of a pharmacists intervention lead to a decrease in the number of polypharmacy patients in medical clinics compared to a control group of medical clinics?
- Will the use of a pharmacist intervention lead to an increase in the polypharmacy patients health-related quality of life compared to a control group?
- Conditions
- Polypharmacy Patients, Pharmacist Intervention
- Being tested
- Systematic pharmacist intervention
- Keywords
- polypharmacy patients, pharmacist intervention, health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic pharmacist interventionOther
Already described in the arm group intervention group for patient level
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - Medical clinics | Experimental | Medical clinics receiving the pharmacist intervention described in the intervention group for patient level Receives: Other: Systematic pharmacist intervention |
| Control group - medical clinics | No intervention | All medical clinics that are enrolled in the trial will eventually receive the intervention at some point. As some medical clinics act as the control group to being with. |
| Intervention group - patient level | Experimental | The intervention consists of two subgroups: Intervention pharmacist and intervention proposals. As the pharmacist conducts medication reviews of the polypharmacy patients in the medical clinic they can make a note to the physician about fx a specific medication the physician needs to pay attention to. These polypharmacy patients are enrolled in the group intervention proposals and are asked to complete questionaries at baseline and follow-up. Ultimately, it is up to the physician to react to the note in the polypharmacy patients medical record. Therefore the pharmacist only makes a note in the journal of the patient and does nothing else.
The group intervention pharmacist is polypharmacy patients where the pharmacist conducts a medication review and develops suggested interventions proposals for each participant Receives: Other: Systematic pharmacist intervention |
| Control group - patient level | No intervention | The control group will have access to usual care and other health services within the healthcare systems. Participants randomised to the control group are invited to participate in the evaluation of the current treatment in the primary health care sector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in polypharmacypatients medication
The primary outcome at patient level is changes in the patients medication use at baseline and 6-month follow-up defined as the amount of medicine prescribed. Measuring the amount of medicine is extracted by the pharmacist from the participants SMC.
Measured: 6 months
Secondary outcomes (5)
Health-related quality of life
HRQoL as measures of effect for the economic evaluations. HRQoL is measured by the EQ-5D-5L questionnaire and converted into quality of life which is a scale from o to 1 where 0 correspondts to death and 1 indicates perfect health
Measured: 6 months
Healthcare services
Use of healthcare services to estimate costs for the economic evaluation. Use of health care services are measured by Danish health registers.
Measured: 6 months months and long term follow-up
Healthcare services
Use of healthcare services to estimate costs for the economic evaluation. Use of health care services are measured by Danish health registers.
Measured: Up to 10 years
Amount of medicine pr patient in each medical clinic
The primary outcome for the medical clinics are changes in the patients medication at baseline and at six months follow-up
Measured: 6 months
Medical clinic number of polypharmacy patients
. A count of the total number of polypharmacy patients in each medical clinic is conducted at baseline and six months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Sep 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypharmacy PatientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT of The intervention and control groups will both have access to their physician as usual. At the medical clinic level the intervention group will receive the pharmacist intervention and other medical clinics will act as control groups. At patient level the intervention group will receive the pharmacist intervention and the control group are asked to evaluate the current treatment option.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Quality Unit for General Practice North Denmark Region
- Responsible party
- Principal investigator, Josefine Mikkelsen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945447
- Sponsor's protocol ID
- Aalborg University
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pharmacist Intervention in the Primary Sector on Patients Medication and Health-related Quality of Life: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04945447
- Acronym / sponsor ID
- Aalborg University
- Conditions
- Polypharmacy Patients, Pharmacist Intervention
- Keywords
- polypharmacy patients, pharmacist intervention, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- The Quality Unit for General Practice North Denmark Region
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 30 Jun 2021 (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.
Brief summary: The randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. The purpose is to gain more knowledge to patients and physicians about their medication and to see changes in the patient's medication and health-related quality of life.
Detailed description
The main objective of the randomised controlled trial is to investigate the clinical effects of the roll-out of the systematic offer from Nord-KAP in the North Denmark Region at two different levels (medical clinic and patient-level). The primary outcome is changes in the participant's medicine from baseline to follow up and changes in healthcare usage Secondary outcomes include investigation of cost-effectiveness and changes in patients health-related quality of life.
The hypothesis is that the regional intervention delivered by the pharmacists, from Nord-KAP, can lead to a decrease in medical products compared with a control group between baseline and at 6-month follow-up.
- Will the use of a pharmacists intervention lead to a decrease in the number of polypharmacy patients in medical clinics compared to a control group of medical clinics?
- Will the use of a pharmacist intervention lead to an increase in the polypharmacy patients health-related quality of life compared to a control group?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- RCT of The intervention and control groups will both have access to their physician as usual. At the medical clinic level the intervention group will receive the pharmacist intervention and other medical clinics will act as control groups. At patient level the intervention group will receive the pharmacist intervention and the control group are asked to evaluate the current treatment option.
| Arm | Type | Receives |
|---|---|---|
| Intervention group - Medical clinics | Experimental | Other: Systematic pharmacist interventionMedical clinics receiving the pharmacist intervention described in the intervention group for patient level |
| Control group - medical clinics | No intervention | –All medical clinics that are enrolled in the trial will eventually receive the intervention at some point. As some medical clinics act as the control group to being with. |
| Intervention group - patient level | Experimental | Other: Systematic pharmacist interventionThe intervention consists of two subgroups: Intervention pharmacist and intervention proposals. As the pharmacist conducts medication reviews of the polypharmacy patients in the medical clinic they can make a note to the physician about fx a specific medication the physician needs to pay attention to. These polypharmacy patients are enrolled in the group intervention proposals and are asked to complete questionaries at baseline and follow-up. Ultimately, it is up to the physician to react to the note in the polypharmacy patients medical record. Therefore the pharmacist only makes a note in the journal of the patient and does nothing else. The group intervention pharmacist is polypharmacy patients where the pharmacist conducts a medication review and develops suggested interventions proposals for each participant |
| Control group - patient level | No intervention | –The control group will have access to usual care and other health services within the healthcare systems. Participants randomised to the control group are invited to participate in the evaluation of the current treatment in the primary health care sector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with more than 5 medicinal products prescribed besides skin remedies and antibiotic
- Above 18 years
- Patients in continuous medication treatment
Key exclusion criteria (5 listed)
- Terminal patients
- Patients who are not motivated to comply with the instruction of the trial
- Do not speak/or understand written Danish
- Patients lacking legal capacity
- Patients living at nursing homes
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 |
|---|---|---|
| Systematic pharmacist interventionAlready described in the arm group intervention group for patient level | Other | Intervention group - Medical clinics, Intervention group - patient level |
Primary outcome
Changes in polypharmacypatients medication
Time frame: 6 months
The primary outcome at patient level is changes in the patients medication use at baseline and 6-month follow-up defined as the amount of medicine prescribed. Measuring the amount of medicine is extracted by the pharmacist from the participants SMC.
5 secondary outcomes
Health-related quality of life
Time frame: 6 months
Healthcare services
Time frame: 6 months months and long term follow-up
Healthcare services
Time frame: Up to 10 years
Amount of medicine pr patient in each medical clinic
Time frame: 6 months
Medical clinic number of polypharmacy patients
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Link to the homepage of the pharmacist intervention from the quality unit for general practice north denmark regionLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic pharmacist intervention in people with Polypharmacy Patients and Pharmacist Intervention, run by Aalborg University at 1 site in Denmark.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper Søndergaard, MsC (+4599403527, jhsxn@dcm.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in polypharmacypatients medication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.