Improving Medication Reviews to Polypharmacy Patients

NCT04945447 | Unknown DMC

• 1 other identifier: Aalborg University
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy Patients; Pharmacist Intervention

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in polypharmacypatients medication

  The 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.

  6 months

Secondary Outcomes (5)

• Health-related quality of life

  6 months

• Healthcare services

  6 months months and long term follow-up

• Healthcare services

  Up to 10 years

• Amount of medicine pr patient in each medical clinic

  6 months

• Medical clinic number of polypharmacy patients

  6 months

Study Arms (4)

Intervention group - Medical clinics

EXPERIMENTAL

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

Other: Systematic pharmacist intervention

Control group - medical clinics

NO INTERVENTION

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.

Intervention group - patient level

EXPERIMENTAL

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

Other: Systematic pharmacist intervention

Control group - patient level

NO INTERVENTION

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

Interventions

Systematic pharmacist intervention OTHER

Already described in the arm group intervention group for patient level

Intervention group - Medical clinics; Intervention group - patient level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• The Quality Unit for General Practice North Denmark Region: collaborator

Study Sites (1)

The quality unit for genreal practice

Aalborg, North Denmark, Denmark

RECRUITING

Related Links

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

Central Study Contacts

Jesper Søndergaard, MsC

CONTACT

+4599403527; jhsxn@dcm.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The medical clinics and polypharmacy patients are blinded from the randomisation process.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 30, 2021
• Study Start: September 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)