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Clinical Pharmacist Intervention for Blood Clot Management

N/A

Waitlist Available

Led By Alok Kapoor, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post enrollment

Awards & highlights

Study Summary

This trial will help determine whether an intervention can improve quality of care for patients prescribed blood-thinners (DOACs), by reducing medication errors and improving patient knowledge and adherence.

Who is the study for?

This trial is for adults (18+) who've recently been prescribed a DOAC, either as new users or those with worsening blood clotting or bleeding issues. It's also for patients discharged from the hospital with a DOAC prescription. Participants must understand English, Portuguese, or Spanish. Hospitalized individuals, minors, prisoners, and pregnant women cannot join.Check my eligibility

What is being tested?

The study is testing how well clinical pharmacist interventions can help manage the risks of direct oral anticoagulants (DOACs). The goal is to prevent medication errors and improve care transitions, patient knowledge about their medication, and adherence to DOAC therapy.See study design

What are the potential side effects?

While this trial focuses on improving management rather than drug effects directly, potential side effects of DOACs generally include increased risk of bleeding events that could range from minor bruising to more serious internal bleeds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors

Secondary outcome measures

Medication Possession Ratio (MPR) to assess medication adherence

Number of missed or extra doses to assess medication adherence

Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Clinical Pharmacist InterventionExperimental Treatment1 Intervention

Two intervention pharmacists will deliver the intervention. First, a pharmacy technician will call the patient to ensure access and affordability. Next the clinical pharmacist will call to conduct an initial consultation and educational session, documenting the findings and recommendations related to this consultation in the Electronic Medical Record (EMR). Finally, the intervention staff will send educational materials customized to the patient preference - short video clips, print materials, or an email with links to print materials. Over the remaining weeks of the study, the intervention pharmacists will field questions from patients, perform two follow up monthly phone calls, order and follow up on renal and hepatic function lab work, and write an off-service note.

Group II: ControlActive Control1 Intervention

Control Patients will be provided with educational materials. Control patients will receive no additional guidance.

0 / 1Eligibility criteria met