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

Quality of Life Clinical Trial

— MEDCOOR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06383364
• Other study ID #: SHS-Pharm - 1 - 2024
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Medication Review
• Medication Therapy Management
• Polypharmacy
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Denmark	Sygehus Sønderjylland	Aabenraa	Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 quality 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.