Medication ReviewMEDCOORNCT06383364
The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment
A study testing Medication Coordinator in people with Medication Review and Polypharmacy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Review, Polypharmacy, Potentially Inappropriate Medication
- What is being tested?
- Medication Coordinator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2024to 1 May 2026
- 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
- all hospitalized patients, who are prescribed at least five medications specified in the Electronic Patient Journal (EPJ) used at ward
Who cannot join
- unable to communicate in Danish, cognitively impaired e.g. suffering from dementia or Alzheimer's, or cannot cooperate due to e.g. hallucination or aggressive behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment (MEDCOOR) - Randomized Controlled Trial
To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage.
Read the detailed description
Patients' safety can be compromised in the transition of care between healthcare sectors. Optimal information flow across healthcare sectors and individualized medication treatment tailored to each patient is key to prevent adverse events and optimize patient treatment. Particularly, the inclusion of the general practitioner is important in this process; it could become a challenge to keep medication changes if this communication link is missing. The framework for complex intervention allows flexibility and adaption in meeting patients' needs by implementing tailored, possibly complex interventions in different healthcare settings. To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan. The primary outcome is the proportion of potentially inappropriate medications. Secondary outcomes include patient-reported outcomes i.e., quality of life and medication burden. Additional outcomes include the patient's individual Medication Risk Score, if the patients are readmitted, and if the patients have contacted the staff at the hospital unit after the hospital discharge.
- Conditions
- Medication Review, Polypharmacy, Potentially Inappropriate Medication, Quality of Life, Medication Therapy Management
- Being tested
- Medication Coordinator
- Keywords
- Polypharmacy, Medication review, Patient care management, Empowerment, Potentially inappropriate medication list, Hospital to home transition, Medication quality, medication optimization, Treatment burden
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication CoordinatorBehavioural
The Medication Coordinator calls the patient app seven days after discharge in the transition of care from hospital to home
| Study group | Role | What they receive |
|---|---|---|
| Interventions group | Active comparator | The Medication Coordinator facilitates the medication reviews in close collaboration with the patients by applying concepts of motivational interview in combination with My Medication Plan Receives: Behavioral: Medication Coordinator |
| Control group | No intervention | Usual treatment from a team consisting of hospital physicians, nurses, nurse assistants, and as needed occupational therapists, physiotherapist, and clinical dieticians. Medication reconciliation might be a part of the patients' usual care performed by physicians or pharmacologist present at the acute ward. Hospital physicians and/or nurses might perform patient counselling about medication treatment during hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in potentially inappropriate medication according to Potentially Inappropriate Medication List
Evaluating the patients drug treatment to assess if a drug is a potentially inappropriate medication
Measured: Baseline and 6 months
Secondary outcomes (6)
Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS.
EQ-5D contains five questions regarding five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression each with five answer categories: no problems, slight problems, moderate problems, severe problems, and extreme problems. Permission for using the Danish EQ-5D version have been granted by EuroQol.
The EQ-VAS is a vertical VAS with the patient reporting their perceived quality of life from 0-100 (60). The endpoints are labelled with "The worst health you can imagine" (0) and "The best health you can imagine" (100). This VAS is used to quantify the measure of health that reflects the patient's own perception.
Measured: Baseline and 3 months
Evaluation of patients experienced quality of life with visual analogue scale (VAS).
The patients are to score their experienced VAS regarding quality of life with VAS.
The VAS is a vertical VAS and ranges from zero (low quality of life) to 100 (the highest quality of life) by numbers. The endpoints are label with "The worst quality of life you can image" (0) and "The highest quality of life you can image" (100).
Measured: Baseline and 3 months
Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ).
The MTBQ is a validated tool to assess patients perceived treatment burden. Treatment burden is described as patients perception of the effort required to look after their health and the effect of this on their everyday life. A Danish version of the MTBQ has been validated and is applied upon permission.
The MTBQ is a ten-item questionnaire with good content validity, high internal reliability, and good construct validity. The questions covers aspects of medication management self-monitoring, contact with healthcare professionals, obtaining information, implementing life-style changes, and relying on help. The answers are a five point Likert scale with the possibilities: "Not difficult" (0), "A little difficult" (1), "Quite difficult" (2), "Very difficult" (3), "Extremely difficult" (4), and "Does not apply" (0). The MTBQ scores are categorized into no burden (score 0), low burden (score < 10), medium burden (score 10-22), and high burden (score ≥ 22).
Measured: Baseline and 3 months
Evaluation of patients experienced medication burden with visual analogue scale (VAS).
An additional VAS regarding treatment burden is added. The VAS is a vertical VAS and ranges from zero (no burden at all) to 100 (the highest burden imagined) by numbers. The endpoints are labelled with "The worst burden you can imagine" (0) and "The highest burden you can imagine" (100).
Measured: Baseline and 3 months
Patient readmission 30 days after hospital discharge
Patient readmissions are evaluated 30 days after hospital discharge. As a "did" or "did not" and a time-to-event, with a restriction of 30 days. The readmissions are assessed through the electronic patient journal.
Measured: 30 days after the patient has been discharged from the hospital.
Patient contact to the ward 30 days after hospital discharge
Patient contact to the ward are evaluated 30 days after hospital discharge. As a "did" or "did not" and a time-to-event, with the restriction of 30 days. And if possible to assess which question the patient had to the ward, if it was drug-related or more disease specific. The readmission are assessed through the electronic patient journal.
Measured: 30 days after the patient has been discharged from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jun 2024
- Primary completion1 May 2026
- Study completion1 May 2026
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 Medication ReviewStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383364
- Sponsor's protocol ID
- SHS-Pharm - 1 - 2024
- Acronym
- MEDCOOR
- Status last verified
- May 2026
- First submitted
- 18 Mar 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schlunsen M, Graabaek T, Pedersen AK, Kampmann JD, Kjeldsen LJ. Study protocol: The effect of a Medication Coordinator on the quality of patients' medication treatment (MEDCOOR)-Randomized controlled trial. PLoS One. 2024 Nov 26;19(11):e0314023. doi: 10.1371/journal.pone.0314023. eCollection 2024.
PubMed 39591420
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment (MEDCOOR) - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06383364
- Acronym / sponsor ID
- MEDCOOR / SHS-Pharm - 1 - 2024
- Conditions
- Medication Review, Polypharmacy, Potentially Inappropriate Medication, Quality of Life, Medication Therapy Management
- Keywords
- Polypharmacy, Medication review, Patient care management, Empowerment, Potentially inappropriate medication list, Hospital to home transition, Medication quality, medication optimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 25 Apr 2024 (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.
To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage.
Detailed description
Patients' safety can be compromised in the transition of care between healthcare sectors. Optimal information flow across healthcare sectors and individualized medication treatment tailored to each patient is key to prevent adverse events and optimize patient treatment. Particularly, the inclusion of the general practitioner is important in this process; it could become a challenge to keep medication changes if this communication link is missing. The framework for complex intervention allows flexibility and adaption in meeting patients' needs by implementing tailored, possibly complex interventions in different healthcare settings. To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan. The primary outcome is the proportion of potentially inappropriate medications. Secondary outcomes include patient-reported outcomes i.e., quality of life and medication burden. Additional outcomes include the patient's individual Medication Risk Score, if the patients are readmitted, and if the patients have contacted the staff at the hospital unit after the hospital discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventions group | Active comparator | Behavioral: Medication CoordinatorThe Medication Coordinator facilitates the medication reviews in close collaboration with the patients by applying concepts of motivational interview in combination with My Medication Plan |
| Control group | No intervention | –Usual treatment from a team consisting of hospital physicians, nurses, nurse assistants, and as needed occupational therapists, physiotherapist, and clinical dieticians. Medication reconciliation might be a part of the patients' usual care performed by physicians or pharmacologist present at the acute ward. Hospital physicians and/or nurses might perform patient counselling about medication treatment during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all hospitalized patients, who are prescribed at least five medications specified in the Electronic Patient Journal (EPJ) used at ward
Key exclusion criteria (1 listed)
- unable to communicate in Danish, cognitively impaired e.g. suffering from dementia or Alzheimer's, or cannot cooperate due to e.g. hallucination or aggressive behavior
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 CoordinatorThe Medication Coordinator calls the patient app seven days after discharge in the transition of care from hospital to home | Behavioural | Interventions group |
Primary outcome
Change in potentially inappropriate medication according to Potentially Inappropriate Medication List
Time frame: Baseline and 6 months
Evaluating the patients drug treatment to assess if a drug is a potentially inappropriate medication
6 secondary outcomes
Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS.
Time frame: Baseline and 3 months
Evaluation of patients experienced quality of life with visual analogue scale (VAS).
Time frame: Baseline and 3 months
Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ).
Time frame: Baseline and 3 months
Evaluation of patients experienced medication burden with visual analogue scale (VAS).
Time frame: Baseline and 3 months
Patient readmission 30 days after hospital discharge
Time frame: 30 days after the patient has been discharged from the hospital.
Patient contact to the ward 30 days after hospital discharge
Time frame: 30 days after the patient has been discharged from the hospital.
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 20 May 2026.
- Derived from this study: PubMed 39591420Schlunsen M, Graabaek T, Pedersen AK, Kampmann JD, Kjeldsen LJ. Study protocol: The effect of a Medication Coordinator on the quality of patients' medication treatment (MEDCOOR)-Randomized controlled trial. PLoS One. 2024 Nov 26;19(11):e0314023. doi: 10.1371/journal.pone.0314023. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coordinator in people with Medication Review and Polypharmacy, run by University of Southern Denmark 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 1 inclusion and 1 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 20 May 2026. 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?
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?
Change in potentially inappropriate medication according to Potentially Inappropriate Medication List (time frame: Baseline and 6 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 NCT06383364, 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 20 May 2026.