Medication Administered in Error Clinical Trial
— MEDCOOROfficial title:
The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment (MEDCOOR) - Randomized Controlled Trial
Verified date | April 2024 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 140 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Sygehus Sønderjylland | Aabenraa | Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of potentially inappropriate medication according to Potentially Inappropriate Medication List | Evaluating the patients drug treatment based on two Potentially Inappropriate Medication List: the Danish National Discontinuation List (Seponeringsliste) and the international Screening Tool of Older Person's Potentially Inappropriate Prescriptions | Baseline and 6 months | |
Secondary | 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. |
Baseline and 3 months | |
Secondary | 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 quali-ty of life you can image" (0) and "The highest quality of life you can image" (100). |
Baseline and 3 months | |
Secondary | 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). |
Baseline and 3 months | |
Secondary | 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). | Baseline and 3 months | |
Secondary | 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. | 30 days after the patient has been discharged from the hospital. | |
Secondary | 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. | 30 days after the patient has been discharged from the hospital. |
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