AnticoagulantNCT03154489
Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care
A study testing acenocoumarol in people with Anticoagulant and Pharmacogenetics, run by Universidad San Jorge at 1 site in Spain.
Trial summary
The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant, Pharmacogenetics, Community Pharmacy Services
- What is being tested?
- acenocoumarol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSpain
- Study dates
- 22 May 2017to 22 Sep 2019
- Phase
- Interventional
- 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
Who may be able to join
- Submit a TTR less than 70% in the last 6 months.
Who cannot join
- Not sign the informed consent.
- Present cognitive difficulties for the project.
Trial locations and contacts
1 site in 1 country.
About this study
The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the impact of the Program of medication review with follow-up in collaboration with doctors and nurses in primary care improves the degree of control of the patients under treatment with coumarin anticoagulants. Method: a randomized, controlled study for the main objective. Population and scope of study: Patients on treatment with coumarin anticoagulants with time in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each patient will be followed by a period of 6 months. After this period, patients in the control group (CG) will receive the service of medication review with follow-up for a period of time equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result: Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of patients and professionals involved. Statistical analysis and sample size: 204 patients. Multivariate analysis will be used and cost-effectiveness..
- Conditions
- Anticoagulant, Pharmacogenetics, Community Pharmacy Services, Drug Utilization Review, Medication Therapy Management
- Being tested
- acenocoumarol, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acenocoumarolOther
medication review with follow-up in acenocoumarol treatment
controlOther
group
| Study group | Role | What they receive |
|---|---|---|
| Acenocoumarol | Other | Not described Receives: Other: acenocoumarol |
| control group | Other | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of medication review with follow-up
Compare the effectiveness of medication review with follow-up in collaboration with doctors and nurses of primary care patients in treatment with anticoagulants coumarins against the usual practice used actually. Principally studying INR control of this patients during 6 months.
Measured: 6 months
Secondary outcomes (6)
Quality of life related to health
Evaluate the effect of specific pharmaceutical interventions (medication review with follow-up) aimed at patients in treatment with coumarin anticoagulants within the framework of medication review with follow-up quality of life related to health using validated questionnaires.
Measured: 6 months
Study of patients habits
Evaluate the effect of medication review with follow-up on the adherence of the patient, eating habits in relation to the consumption of vitamin K, and their knowledge about the use of acenocoumarol by using validated questionnaires.
Measured: 6 months
Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient
Analyze the clinical utility of the incorporation of additional tools like pharmacogenetic analysis of this four genes (CYP2C9 and VKORC1, ApoE CYP4F2) for clinical decision-making in patients with unstable INR. Thanks to the bibliography is known that these gene affect the individual variability of each patient to the acenocoumarol so is going to be studying patients pharmacogenetics for this four genes.
Measured: 6 months
Satisfaction in primary care professionals
Evaluate the satisfaction of medical prescribers, nurses, patients and community pharmacists with the usefulness of medication review with follow-up realized by a pharmacist with focus groups
Measured: 6 months
Review of clinical guidelines used in primary care
Assess therapeutic appropriateness of coumarins anticoagulants in relation to clinical practice guidelines used actually.
Measured: 6 months
Economic outcomes
Evaluate the effect of specific pharmaceutical interventions (medication review with follow-up) aimed at patients in treatment with coumarin anticoagulants within the framework of medication review with follow-up. The economic outcome is going to be assess by following patients if they have admissions in hospital due to bad INR control or they need some extra visits to doctor. This cost a lot to Health System and if it can be avoided it would save costs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start22 May 2017
- Primary completion22 Jan 2019
- Study completion22 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154489
- Sponsor's protocol ID
- 914913001
- Status last verified
- May 2021
- First submitted
- 17 Apr 2017
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saez-Benito A, Berenguer N, Magallon R, Olivan B, Ezquerra L, Saez-Benito L. Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial. Res Social Adm Pharm. 2023 Dec;19(12):1570-1578. doi: 10.1016/j.sapharm.2023.08.007. Epub 2023 Aug 26.
PubMed 37704534
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care
- ClinicalTrials.gov ID
- NCT03154489
- Acronym / sponsor ID
- 914913001
- Conditions
- Anticoagulant, Pharmacogenetics, Community Pharmacy Services, Drug Utilization Review, Medication Therapy Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 22 May 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Sep 2019 (actual)
- First posted
- 16 May 2017 (actual)
- 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.
The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the impact of the Program of medication review with follow-up in collaboration with doctors and nurses in primary care improves the degree of control of the patients under treatment with coumarin anticoagulants. Method: a randomized, controlled study for the main objective. Population and scope of study: Patients on treatment with coumarin anticoagulants with time in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each patient will be followed by a period of 6 months. After this period, patients in the control group (CG) will receive the service of medication review with follow-up for a period of time equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result: Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of patients and professionals involved. Statistical analysis and sample size: 204 patients. Multivariate analysis will be used and cost-effectiveness..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acenocoumarol | Other | Other: acenocoumarol |
| control group | Other | Other: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Submit a TTR less than 70% in the last 6 months.
Key exclusion criteria (2 listed)
- Not sign the informed consent.
- Present cognitive difficulties for the project.
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 |
|---|---|---|
| acenocoumarolmedication review with follow-up in acenocoumarol treatment | Other | Acenocoumarol |
| controlgroup | Other | control group |
Primary outcome
Effectiveness of medication review with follow-up
Time frame: 6 months
Compare the effectiveness of medication review with follow-up in collaboration with doctors and nurses of primary care patients in treatment with anticoagulants coumarins against the usual practice used actually. Principally studying INR control of this patients during 6 months.
6 secondary outcomes
Quality of life related to health
Time frame: 6 months
Study of patients habits
Time frame: 6 months
Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient
Time frame: 6 months
Satisfaction in primary care professionals
Time frame: 6 months
Review of clinical guidelines used in primary care
Time frame: 6 months
Economic outcomes
Time frame: 6 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 4 May 2021.
- Derived from this study: PubMed 37704534Saez-Benito A, Berenguer N, Magallon R, Olivan B, Ezquerra L, Saez-Benito L. Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial. Res Social Adm Pharm. 2023 Dec;19(12):1570-1578. doi: 10.1016/j.sapharm.2023.08.007. Epub 2023 Aug 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acenocoumarol in people with Anticoagulant and Pharmacogenetics, run by Universidad San Jorge at 1 site in Spain.
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 1 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 4 May 2021. 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 Spain. 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?
Effectiveness of medication review with follow-up (time frame: 6 months). 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 NCT03154489, which also lists 1 linked publication.
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 4 May 2021.