Improving Medication Reviews to Polypharmacy Patients

Study Overview
=================
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?

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

Conditions
-----------------
Polypharmacy Patients, Pharmacist Intervention

Intervention / Treatment
-----------------
* Other: Systematic pharmacist intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group - Medical clinics<br>Medical clinics receiving the pharmacist intervention described in the intervention group for patient level | Other: Systematic pharmacist intervention<br>* Already described in the arm group intervention group for patient level<br>|
| No Intervention: Control group - medical clinics<br>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<br>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<br>* Already described in the arm group intervention group for patient level<br>|
| No Intervention: Control group - patient level<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacist intervention, polypharmacy patients, health-related quality of life