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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451692
Other study ID # SHS-Pharm2 - 2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2027

Study information

Verified date June 2024
Source University of Southern Denmark
Contact Joo Hanne Poulsen Revell
Phone +45 79974906
Email Joo.Hanne.Poulsen.Revell@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To examine the effect of a cross-sectoral medication review intervention to admitted multi-morbid, polypharmacy patients aged 65+ at SHS in two settings; an acute admission unit (typical admission time < 48 hours) and a medical outpatient setting (patients routinely visits for follow-up, diagnosis or treatment, but do require a bed or overnight care).


Description:

Lack of medication treatment coordination among especially multi-morbid patient's results in suboptimal medication treatment, adverse effects, increased use of resources, hospital admissions and premature death. Further, an aging population is a challenge to healthcare systems worldwide as older adults are vulnerable to non-communicable diseases and multi-morbidity. The age distribution varies across Denmark creating demographic inequality with a higher proportion of elderly in several municipalities in Southern Jutland and on a national level, the population aged 70+ already accounts for more than a third of all hospital days. As the population ages, the concept of frailty becomes increasing in the provision of health care to an ageing population, and the Clinical Frailty Scale (CFS) can be used as a judgement-based frailty tool to evaluate specific domains including comorbidity, function, and cognition to generate a frailty score. In addition, an attempt to detect patients at high risk of medication errors is the Medicine Risk Score (MERIS) where acutely admitted patients are allocated into low and high risk of potential ADEs by predefined detection limits. Further, These components will be used to determine In addition, an understudied patient group within polypharmacy and PIPs, are patients with dementia creating inequality among patient groups. The use of polypharmacy and Potential Inappropriate Prescribing are widespread in this patient group, and dementia is well-known to have a negative effect on overall mortality, which demonstrates the need for interventions to improve medication treatment in people with dementia. Intervention studies have examined the effects of pharmacist-led medication reviews in different hospital settings with various outcomes, but no exact model for prioritising patient medication review exists. Thus, there is a need to identify patients who will benefit most from a medication review in terms of outcomes, such as readmission, emergency department and general practitioner contacts. The aim of this project is to examine the effect of a cross-sectoral medication review between a clinical pharmacist and a medical specialist in coordination with the General Practitioner (GP), including patients from Hospital Sønderjylland, University Hospital of Southern Denmark (SHS).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 800
Est. completion date June 1, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - all hospitalized patients who are prescribed at least seven medications specified in the Electronic Patient Journal (EPJ) at admission Exclusion Criteria: - terminal patients or patients with a short life expectancy, patients residing in another region, patients who are discharged on the day of inclusion, and finally patients who do not speak Danish.

Study Design


Intervention

Other:
Clinical pharmacist
The clinical pharmacist calls the patients' GP 90 days after discharge for follow-up

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Southern Denmark

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction with the intervention Patients' satisfaction and experience with the medication review and intervention are explored through a smaller sample of intervention patients (approx. 25%, 50 patients) using an evaluation survey and a 5-likert scale. The evaluation will be conducting through telephone by the project manager, who will follow a structured evaluation survey and register the patients reply continuously in an online survey form in RedCap. 7 to 10 days after discharge
Other Evaluation of the collaboration among clinical pharmacists, medical specialists, and GPs The evaluation of the collaboration will be explored through a survey to clinical pharmacists, medical specialists, and GPs. The main focus are the collaboration with the GP and medical doctors; potential barriers to a fruitful collaboration in the team of clinical pharmacist, medical specialist and the GP; the feasibility of the intervention with pharmacist-led medication review to admitted patients, and the experience with the optimized discharge summary containing pharmacist interventions from medication reviews. A 5-likert scale will be used. 10 months after the randomization of the first participant in each setting an online survey link will be sent clinical pharmacists, medical specialists, and GPs
Primary Readmission and emergency department rate. The number of acute readmissions and emergency department visits between 4 hours and 30 days after discharge from the index hospital stay in the intervention group compared with the control group. As a "yes" or "no" and a time-to-event. Potential readmissions are assessed through the electronic patient journal. Up to thirty days after discharge
Secondary Acute admission Time to first acute admission after discharge from index hospital stay for the intervention and control group (up to 90 days follow-up). As a "yes" or "no" and a time-to-event. Potential acute admissions are assessed through the electronic patient journal. Up to 90 days after discharge
Secondary Mortality The mortality rate after 30 and 90 days respectively after discharge will be evaluated. As a "yes" or "no" and a time-to-event. The mortality will be identified from patient journals. 30 and 90 days after discharge
Secondary GP contacts The GP visit rate (number) will be identified at a follow-up telephone contact with the GP 90 days after discharge. As a "yes" or "no" to GP contact within the time frame and a time-to-event related to "yes". Up to 90 days after discharge
Secondary Implementation rate The implementation rate (number) of pharmacist recommendations and potential medication changes from the medication review made by the GP will be identified, 30 and 90 days respectively after index hospital stay. Each recommendation will be evaluated as a "yes", "no", "partly" or "unsure", where "partly" or "unsure" requires additional free text information to support the evaluation. The information will be obtained from the patients' shared medication record Up to 90 days after discharge
Secondary Compliance with medical treatment Patient compliance with their medical treatment will be obtained from the patients' shared medication record with information on all patient purchases of prescribed medications. As a "yes", "no", "partly" or "unsure". Up to 90 days after discharge
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