Clinical trial NCT04945447: Improving Medication Reviews to Polypharmacy Patients
Official title: Effects of a Pharmacist Intervention in the Primary Sector on Patients Medication and Health-related Quality of Life: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polypharmacy Patients
Pharmacist Intervention
Keywords: polypharmacy patients
pharmacist intervention
health-related quality of life
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: The Quality Unit for General Practice North Denmark Region
First posted: 2021-06-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT of The intervention and control groups will both have access to their physician as usual. At the medical clinic level the intervention group will receive the pharmacist intervention and other medical clinics will act as control groups. At patient level the intervention group will receive the pharmacist intervention and the control group are asked to evaluate the current treatment option.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Brief summary: The randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. The purpose is to gain more knowledge to patients and physicians about their medication and to see changes in the patient's medication and health-related quality of life.

Detailed description: The main objective of the randomised controlled trial is to investigate the clinical effects of the roll-out of the systematic offer from Nord-KAP in the North Denmark Region at two different levels (medical clinic and patient-level). The primary outcome is changes in the participant's medicine from baseline to follow up and changes in healthcare usage Secondary outcomes include investigation of cost-effectiveness and changes in patients health-related quality of life.

The hypothesis is that the regional intervention delivered by the pharmacists, from Nord-KAP, can lead to a decrease in medical products compared with a control group between baseline and at 6-month follow-up.

* Will the use of a pharmacists intervention lead to a decrease in the number of polypharmacy patients in medical clinics compared to a control group of medical clinics?
* Will the use of a pharmacist intervention lead to an increase in the polypharmacy patients health-related quality of life compared to a control group?

Eligibility criteria: Inclusion Criteria:

* Patients with more than 5 medicinal products prescribed besides skin remedies and antibiotic
* Above 18 years
* Patients in continuous medication treatment

Exclusion Criteria:

* Terminal patients
* Patients who are not motivated to comply with the instruction of the trial
* Do not speak/or understand written Danish
* Patients lacking legal capacity
* Patients living at nursing homes

Primary outcomes:
measure: Changes in polypharmacypatients medication
timeFrame: 6 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 6 months
measure: Healthcare services
timeFrame: 6 months months and long term follow-up
measure: Healthcare services
timeFrame: Up to 10 years
measure: Amount of medicine pr patient in each medical clinic
timeFrame: 6 months
measure: Medical clinic number of polypharmacy patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: The quality unit for genreal practice
state: North Denmark Region
Study officials:
References: