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

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.

Study Overview

• Status: Recruiting
• Conditions: Polypharmacy Patients; Pharmacist Intervention
• Intervention / Treatment: Other: Systematic pharmacist intervention

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?

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Søndergaard, MsC; Phone Number: +4599403527; Email: jhsxn@dcm.aau.dk

Study Locations

• Denmark
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark
      • Recruiting
      • The quality unit for genreal practice
      • Contact: Jesper Søndergaard, MsC; Phone Number: +4599403527; Email: jhsxn@dcm.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group - Medical clinics; Medical clinics receiving the pharmacist intervention described in the intervention group for patient level	Other: Systematic pharmacist intervention; Already described in the arm group intervention group for patient level
NO_INTERVENTION: 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.
EXPERIMENTAL: 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	Other: Systematic pharmacist intervention; Already described in the arm group intervention group for patient level
NO_INTERVENTION: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	HRQoL 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	6 months
Healthcare services	Use of healthcare services to estimate costs for the economic evaluation. Use of health care services are measured by Danish health registers.	6 months months and long term follow-up
Healthcare services	Use of healthcare services to estimate costs for the economic evaluation. Use of health care services are measured by Danish health registers.	Up to 10 years
Amount of medicine pr patient in each medical clinic	The primary outcome for the medical clinics are changes in the patients medication at baseline and at six months follow-up	6 months
Medical clinic number of polypharmacy patients	. A count of the total number of polypharmacy patients in each medical clinic is conducted at baseline and six months follow-up	6 months

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Research Unit for General Practice at Aalborg University; The Quality Unit for General Practice North Denmark Region; Danish Center for Clinical Health Services Research at Aalborg University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (ACTUAL): June 30, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: health-related quality of life; pharmacist intervention; polypharmacy patients
• Other Study ID Numbers: Aalborg University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No