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Completed

NCT Number: NCT06383364

The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment

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.

Completed

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Key information

Conditions

Medication Review Behavior Empowerment Medication Therapy Management Polypharmacy Potentially Inappropriate Medication Quality of Life Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all hospitalized patients, who are prescribed at least five medications specified in the Electronic Patient Journal (EPJ) used at ward

Exclusion criteria

  • 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

Treatment and study plan

Medication Coordinator

Behavioral

The Medication Coordinator calls the patient app seven days after discharge in the transition of care from hospital to home

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS.

    Time frame: Baseline and 3 months

    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.

  2. Evaluation of patients experienced quality of life with visual analogue scale (VAS).

    Time frame: Baseline and 3 months

    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).

  3. Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ).

    Time frame: Baseline and 3 months

    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).

  4. Evaluation of patients experienced medication burden with visual analogue scale (VAS).

    Time frame: Baseline and 3 months

    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).

  5. Patient readmission 30 days after hospital discharge

    Time frame: 30 days after the patient has been discharged from the hospital.

    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.

  6. Patient contact to the ward 30 days after hospital discharge

    Time frame: 30 days after the patient has been discharged from the hospital.

    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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment (MEDCOOR) - Randomized Controlled Trial

Acronym: MEDCOOR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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