Improving Medication Reviews to Polypharmacy Patients

NCT ID: NCT04945447

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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?

Conditions

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Polypharmacy Patients Pharmacist Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

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

Study Groups

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Intervention group - Medical clinics

Medical clinics receiving the pharmacist intervention described in the intervention group for patient level

Group Type EXPERIMENTAL

Systematic pharmacist intervention

Intervention Type OTHER

Already described in the arm group intervention group for patient level

Control group - medical clinics

All medical clinics that are enrolled in the trial will eventually receive the intervention at some point. As some medical clinics act as the control group to being with.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group - patient level

The intervention consists of two subgroups: Intervention pharmacist and intervention proposals. As the pharmacist conducts medication reviews of the polypharmacy patients in the medical clinic they can make a note to the physician about fx a specific medication the physician needs to pay attention to. These polypharmacy patients are enrolled in the group intervention proposals and are asked to complete questionaries at baseline and follow-up. Ultimately, it is up to the physician to react to the note in the polypharmacy patients medical record. Therefore the pharmacist only makes a note in the journal of the patient and does nothing else.

The group intervention pharmacist is polypharmacy patients where the pharmacist conducts a medication review and develops suggested interventions proposals for each participant

Group Type EXPERIMENTAL

Systematic pharmacist intervention

Intervention Type OTHER

Already described in the arm group intervention group for patient level

Control group - patient level

The control group will have access to usual care and other health services within the healthcare systems. Participants randomised to the control group are invited to participate in the evaluation of the current treatment in the primary health care sector

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Systematic pharmacist intervention

Already described in the arm group intervention group for patient level

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Quality Unit for General Practice North Denmark Region

UNKNOWN

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Josefine Mikkelsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The quality unit for genreal practice

Aalborg, North Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jesper Søndergaard, MsC

Role: CONTACT

+4599403527

Facility Contacts

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Jesper Søndergaard, MsC

Role: primary

+4599403527

Related Links

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https://vpvp.dk/

Link to the homepage of the pharmacist intervention from the quality unit for general practice north denmark region

Other Identifiers

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Aalborg University

Identifier Type: -

Identifier Source: org_study_id

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