Safety IssuesNCT03527615
Clinical Pharmacist Anticoagulant Stewardship
An observational study of Safety Issues and Anticoagulant Toxicity, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety Issues, Anticoagulant Toxicity
- What is being tested?
- Clinical Pharmacist Medication Review
- How many people
- 4,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 1 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants.
Who may be able to join
- Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants (apixaban, rivaroxaban, or dabigatran).
Who cannot join
- Patients hospitalized in departments without computerized physician order entry.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
Amichai Perlman, PharmD
About this study
Official title: Clinical Pharmacist Led Hospital-Wide Direct Oral Anticoagulant Stewardship Program
Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.
Read the detailed description
The Hadassah Hebrew University Medical Centers' Clinical Pharmacy team initiated a hospital-wide program, in collaboration with the institutions' coagulation specialists, including two hematologists and a clinical pharmacologist, for monitoring and promoting safe and effective prescription of direct oral anticoagulants (DOAC) during hospitalization. Electronic medical records throughout the hospital are screened for DOAC orders. All DOAC orders are assessed by a clinical pharmacist for potentially-inappropriate prescribing. When potentially-inappropriate prescribing or a drug-related problem is identified, the clinical pharmacist provided consultation on management options. In specific cases, additional guidance is provided by coagulation specialists. Consultations are recorded in the electronic medical record. Performance measures are collected and summarized.
- Conditions
- Safety Issues, Anticoagulant Toxicity
- Being tested
- Clinical Pharmacist Medication Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist Medication ReviewOther
Programmatic review of physician orders for direct anticoagulants by clinical pharmacists.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of clinical pharmacist consultations accepted by attending physician.
Calculated by dividing the number of clinical pharmacist consultations accepted, by the number of clinical pharmacist consultations given, during the period. Data for consultation counts will be obtained from patient electronic medical record.
Measured: At forty-eight months
Secondary outcomes (1)
Percent of clinical pharmacist consultations accepted by attending physician.
Calculated by dividing the number of clinical pharmacist consultations accepted, by the number of clinical pharmacist consultations given, during the period. Data for consultation counts will be obtained from patient electronic medical record.
Measured: At six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
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 Safety IssuesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mordechai Muszkat, MD, Principal investigator, Hadassah University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527615
- Sponsor's protocol ID
- DOACPHARM-HMO-CTIL
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perlman A, Horwitz E, Hirsh-Raccah B, Aldouby-Bier G, Fisher Negev T, Hochberg-Klein S, Kalish Y, Muszkat M. Clinical pharmacist led hospital-wide direct oral anticoagulant stewardship program. Isr J Health Policy Res. 2019 Feb 1;8(1):19. doi: 10.1186/s13584-019-0285-9.
PubMed 30709417
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacist Led Hospital-Wide Direct Oral Anticoagulant Stewardship Program
- ClinicalTrials.gov ID
- NCT03527615
- Acronym / sponsor ID
- DOACPHARM-HMO-CTIL
- Conditions
- Safety Issues, Anticoagulant Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 17 May 2018 (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.
Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.
Detailed description
The Hadassah Hebrew University Medical Centers' Clinical Pharmacy team initiated a hospital-wide program, in collaboration with the institutions' coagulation specialists, including two hematologists and a clinical pharmacologist, for monitoring and promoting safe and effective prescription of direct oral anticoagulants (DOAC) during hospitalization. Electronic medical records throughout the hospital are screened for DOAC orders. All DOAC orders are assessed by a clinical pharmacist for potentially-inappropriate prescribing. When potentially-inappropriate prescribing or a drug-related problem is identified, the clinical pharmacist provided consultation on management options. In specific cases, additional guidance is provided by coagulation specialists. Consultations are recorded in the electronic medical record. Performance measures are collected and summarized.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants.
Key inclusion criteria (1 listed)
- Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants (apixaban, rivaroxaban, or dabigatran).
Key exclusion criteria (1 listed)
- Patients hospitalized in departments without computerized physician order entry.
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 |
|---|---|---|
| Clinical Pharmacist Medication ReviewProgrammatic review of physician orders for direct anticoagulants by clinical pharmacists. | Other | – |
Primary outcome
Percent of clinical pharmacist consultations accepted by attending physician.
Time frame: At forty-eight months
Calculated by dividing the number of clinical pharmacist consultations accepted, by the number of clinical pharmacist consultations given, during the period. Data for consultation counts will be obtained from patient electronic medical record.
1 secondary outcome
Percent of clinical pharmacist consultations accepted by attending physician.
Time frame: At six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 30709417Perlman A, Horwitz E, Hirsh-Raccah B, Aldouby-Bier G, Fisher Negev T, Hochberg-Klein S, Kalish Y, Muszkat M. Clinical pharmacist led hospital-wide direct oral anticoagulant stewardship program. Isr J Health Policy Res. 2019 Feb 1;8(1):19. doi: 10.1186/s13584-019-0285-9.
- 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.
Mordechai Muszkat, MD principal investigator
Hadassah University Medical Center
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 Safety Issues and Anticoagulant Toxicity, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 17 May 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amichai Perlman, Pharmd (972505172768, amichaip@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of clinical pharmacist consultations accepted by attending physician. (time frame: At forty-eight 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 NCT03527615, 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 17 May 2018.