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Improving Medication Reviews to Polypharmacy Patients

Effects of a Pharmacist Intervention in the Primary Sector on Patients Medication and Health-related Quality of Life: A Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04945447
Enrollment
400
Registered
2021-06-30
Start date
2021-09-01
Completion date
2025-01-01
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacist Intervention, Polypharmacy Patients

Keywords

polypharmacy patients, pharmacist intervention, health-related quality of life

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?

Interventions

OTHERSystematic pharmacist intervention

Already described in the arm group intervention group for patient level

Sponsors

The Quality Unit for General Practice North Denmark Region
CollaboratorUNKNOWN
Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Masking description

The medical clinics and polypharmacy patients are blinded from the randomisation process.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in polypharmacypatients medication6 monthsThe primary outcome at patient level is changes in the patients medication use at baseline and 6-month follow-up defined as the amount of medicine prescribed. Measuring the amount of medicine is extracted by the pharmacist from the participants SMC.

Secondary

MeasureTime frameDescription
Health-related quality of life6 monthsHRQoL as measures of effect for the economic evaluations. HRQoL is measured by the EQ-5D-5L questionnaire and converted into quality of life which is a scale from o to 1 where 0 correspondts to death and 1 indicates perfect health
Healthcare services6 months months and long term follow-upUse of healthcare services to estimate costs for the economic evaluation. Use of health care services are measured by Danish health registers.
Amount of medicine pr patient in each medical clinic6 monthsThe primary outcome for the medical clinics are changes in the patients medication at baseline and at six months follow-up
Medical clinic number of polypharmacy patients6 months. A count of the total number of polypharmacy patients in each medical clinic is conducted at baseline and six months follow-up

Countries

Denmark

Contacts

Primary ContactJesper Søndergaard, MsC
jhsxn@dcm.aau.dk+4599403527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026