Drug Therapy ManagementNCT02703727
Medication Review Focusing on Anticoagulation Therapy in Swiss Community Pharmacies
An observational study of Drug Therapy Management, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Therapy Management
- What is being tested?
- Extended polymedication check
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- living in a nursing home
- provision of polymedication check in the past
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pharmaceutical Care Research Group University of Basel
Basel, Basel, 4056
About this study
Official title: 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.
- Conditions
- Drug Therapy Management
- Being tested
- Extended polymedication check
- Keywords
- polypharmacy, polymedication check, anticoagulation treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended polymedication checkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| OAC | Patients on oral anticoagulation therapy (OAC) will receive a pharmacists led medication review with a focus on anticoagulation therapy (extended polymedication check) Receives: Behavioral: Extended polymedication check |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Knowledge gaps about oral anticoagulation therapy
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.
Measured: 2 Weeks
Secondary outcomes (1)
Medication possessio ratio (MPR)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug Therapy ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Kurt E Hersberger, Prof., Principal investigator, Pharmaceutical Care Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703727
- Sponsor's protocol ID
- evalPMC-OAC
- Status last verified
- Dec 2016
- First submitted
- 19 Jan 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.
PubMed 22486599Krska J, Avery AJ; Community Pharmacy Medicines Management Project Evaluation Team. Evaluation of medication reviews conducted by community pharmacists: a quantitative analysis of documented issues and recommendations. Br J Clin Pharmacol. 2008 Mar;65(3):386-96. doi: 10.1111/j.1365-2125.2007.03022.x. Epub 2007 Oct 8.
PubMed 17922887Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006 Jun;28(3):165-70. doi: 10.1007/s11096-006-9026-6. Epub 2006 Sep 27.
PubMed 17004019Kwint HF, Faber A, Gussekloo J, Bouvy ML. Effects of medication review on drug-related problems in patients using automated drug-dispensing systems: a pragmatic randomized controlled study. Drugs Aging. 2011 Apr 1;28(4):305-14. doi: 10.2165/11586850-000000000-00000.
PubMed 21428465Bryant LJ, Coster G, Gamble GD, McCormick RN. The General Practitioner-Pharmacist Collaboration (GPPC) study: a randomised controlled trial of clinical medication reviews in community pharmacy. Int J Pharm Pract. 2011 Apr;19(2):94-105. doi: 10.1111/j.2042-7174.2010.00079.x. Epub 2011 Feb 25.
PubMed 21385240
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durchführung Einer Beobachtungsstudie im Rahmen Einer Masterarbeit Zur Identifikation Von Pharmaceutical Care Issues Bei Patienten, Welche Mit Oralen Antikoagulantien Behandelt Werden
- ClinicalTrials.gov ID
- NCT02703727
- Acronym / sponsor ID
- evalPMC-OAC
- Conditions
- Drug Therapy Management
- Keywords
- polypharmacy, polymedication check, anticoagulation treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OAC | – | Behavioral: Extended polymedication checkPatients on oral anticoagulation therapy (OAC) will receive a pharmacists led medication review with a focus on anticoagulation therapy (extended polymedication check) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- living in a nursing home
- provision of polymedication check in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended polymedication checkBehavioral: 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. | Behavioural | OAC |
Primary outcome
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.
1 secondary outcome
Medication possessio ratio (MPR)
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Background: PubMed 22486599Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.
- Background: PubMed 17922887Krska J, Avery AJ; Community Pharmacy Medicines Management Project Evaluation Team. Evaluation of medication reviews conducted by community pharmacists: a quantitative analysis of documented issues and recommendations. Br J Clin Pharmacol. 2008 Mar;65(3):386-96. doi: 10.1111/j.1365-2125.2007.03022.x. Epub 2007 Oct 8.
- Background: PubMed 17004019Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006 Jun;28(3):165-70. doi: 10.1007/s11096-006-9026-6. Epub 2006 Sep 27.
- Background: PubMed 21428465Kwint HF, Faber A, Gussekloo J, Bouvy ML. Effects of medication review on drug-related problems in patients using automated drug-dispensing systems: a pragmatic randomized controlled study. Drugs Aging. 2011 Apr 1;28(4):305-14. doi: 10.2165/11586850-000000000-00000.
- Background: PubMed 21385240Bryant LJ, Coster G, Gamble GD, McCormick RN. The General Practitioner-Pharmacist Collaboration (GPPC) study: a randomised controlled trial of clinical medication reviews in community pharmacy. Int J Pharm Pract. 2011 Apr;19(2):94-105. doi: 10.1111/j.2042-7174.2010.00079.x. Epub 2011 Feb 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E Hersberger, Prof. principal investigator
Pharmaceutical Care Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Therapy Management, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Knowledge gaps about oral anticoagulation therapy (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703727, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.