Medication Review Focusing on Anticoagulation Therapy in Swiss Community Pharmacies

December 7, 2016 updated by: University Hospital, Basel, Switzerland

Durchführung Einer Beobachtungsstudie im Rahmen Einer Masterarbeit Zur Identifikation Von Pharmaceutical Care Issues Bei Patienten, Welche Mit Oralen Antikoagulantien Behandelt Werden

Oral anticoagulation therapy (OAC) entails a high potential for adverse events and strict adherence is needed.Thus, medication review and identification of safety issues and knowledge gaps about OAC is critically important. The polymedication check (PMC) is a reimbursed intermediate medication review focusing on adherence and medication management for Swiss primary care. Investigators aime to assess the impact of the PMC extended with a semi-structured interview focusing on OAC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • Pharmaceutical Care Research Group University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated with oral anticoagulants (vitamin K antagonists and new oral anticoagulants) on long term polypharmacy ( more than 3 drugs over at least 3 months prior to recruitment) who are able to understand written and oral German language.

Description

Inclusion Criteria:

  • intake of an oral anticoagulant
  • more than 3 drugs over at least 3 months prior to recruitment
  • german language (written and spoken)
  • medicines use in self management

Exclusion Criteria:

  • living in a nursing home
  • provision of polymedication check in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OAC
Patients on oral anticoagulation therapy (OAC) will receive a pharmacists led medication review with a focus on anticoagulation therapy (extended polymedication check)
Behavioral: Extended polymedication check

Behavioral: Medication review

Patients on oral anticoagulants and polypharmacy will receive extended polymedication check to identify Pharmaceutical Care Issues, Adherence Issues, Drug related problems and Knowledge Gaps

The PMC has been implemented in 2010 as a new cognitive service provided by any community pharmacist to patient with polypharmacy (n>3 drugs) on long term conditions (> 3 months) and is reimbursed by swiss health insurance. The semi-structured interview contains questions about knowledge on oral anticoagulation therapy. This extended PMC follows a structured predefined protocol.

As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Knowledge gaps about oral anticoagulation therapy
Time Frame: 2 Weeks
Knowledge about oral anticoagulation therapy will be assessed during the extended Polymedication check which includes 8 specific questions on oral anticoagulation knowledge. After 2 Weeks a follow-up telephone interview will be performed and the same 8 questions will be assessed.
2 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication possessio ratio (MPR)
Time Frame: 12 Months
Medication history from pharmacy software will be used to calculate the MPR of all drugs, retrospectively starting 12 months before the extended PMC takes place.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University of Basel

Investigators

  • Principal Investigator: Kurt E Hersberger, Prof., Pharmaceutical Care Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • evalPMC-OAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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