Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns

Novel oral anticoagulant drugs (NOACs) are now increasingly used in clinical practice. Although there are outstanding advantages of NOACs, there are also some shortcomings in use. The behavioral pattern of patients using novel oral anticoagulant drugs can directly affect the effect of anticoagulant therapy.

However, at present, there is no study on behavioral patterns of compliance and cognition in patients using NOACs in China. There are few reports on the management outcomes of NOACs anticoagulant therapy as well. Above all, exploring whether pharmacists change behavioral patterns in patients using NOACs is of great significance to improve the effectiveness and safety and to prove the value of pharmacists who provide pharmaceutical care.

Study Overview

• Status: Recruiting
• Conditions: Behavioral Symptoms; Anticoagulants; Intention
• Intervention / Treatment: Other: Pharmacists' intervention

Detailed Description

The study is a prospective randomized controlled trial. Patients who will use NOACs are prospectively divided into routine group and pharmacist intervention group.

For the intervention group, pharmacists regularly provide telephone and outpatient follow-up combined with patient medication education, establishing database system, telephone reminder, etc. At the 12-week follow-up, behavioral patterns of compliance, self-anxiety, depression status and satisfaction with the pharmacist service will be evaluated in both groups. Pharmacodynamic substitution indicators and endpoints will be collected as well.

Clinical data is designed to be collected from 400 patients, 200 patients each group. Data will be recorded by Epidata dual-track, analyzed by SPSS19.0 software. P<0.05 is considered significant.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Recruiting
    • Peking University First Hospital
    • Contact: Qian Xiang, Ph.D
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • China Rehabilitation Research Center Beijing Boai Hospital
      • Contact: Wen Li, M.S; Email: crrc_lw@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Outpatients or inpatients with anticoagulation indications of novel oral anticoagulant drugs (NOACs).
2. New prescriptions for NOACs, or previous prescriptions for NOACs, not received any intervention by pharmacists before.
3. Written informed consent was obtained from patients or their families.

Exclusion Criteria:

1. Patients who did not use novel oral anticoagulants.
2. Patients who had received interventions from pharmacists, such as medication education.
3. Written informed consent was not obtained from patients or their families.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacists' intervention; A group of participants assigned to a pharmaceutical intervention	Other: Pharmacists' intervention; Medication education: When the patient is enrolled in the intervention group, pharmacists issue an education manual to give a medical education which contains the reasons for using NOACs, the characteristics of the drug, the precautions, and how to monitor the efficacy. Pharmacists re-educate through telephone or clinic during follow-up.; Establish a medical record and remind their follow-up by message, phone every 2 weeks.; Follow-up in the 4th week and 8th week : Pharmacists recommend patients for drug therapy optimization after conducting a full pharmacotherapy review of each patient's medication regimen and remind them to test urinary occult blood every 1-3 months, detect hemoglobin and liver/kidney function every 3-6 months.
No Intervention: Routine therapy; A group of participants assigned to a control (routine therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	The Morisky, Green, and Levine Adherence Scale (MGLS) was used to evaluate the medication compliance of dabigatran etexilate and rivaroxaban during treatment. According to the scores of MGLS, compliance was divided into three groups: A score of 0 indicated high compliance; a score of 1 or 2 illustrated intermediate compliance; and a score of 3 or 4 indicated low compliance.	12 weeks
Mental status	Mental status is assessed by Self-rating Depression Scale (SDS) and Self-rating Anxiety Scale (SAS). The threshold value of depression assessment was 53, the higher the score, the more obvious the tendency of depression. 53-62 is defined as mild depression, 63-72 for moderate depression, 72 points above for severe depression. The standard score of SAS was 50, of which 50-59 is mild anxiety, 60-69 is moderate anxiety and 69 is severe anxiety. The patient's awareness of medication is assessed by a self-designed awareness questionnaire.	12 weeks
anti-Xa and IIa activities	Anti-Xa/IIa activity test is divided into peak concentration and valley concentration detection; peak concentration is 100 ng/ml as the critical value, Valley concentration is 50 ng/ml as the limit, divided into better or poor pharmacodynamic indicators. patients with peak concentration > 100 ng/ml or valley concentration > 50 ng/ml are defined as better pharmacodynamic indicators.	12 weeks

Collaborators and Investigators

• Sponsor: Cui Yimin

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms
• Other Study ID Numbers: 2018[173]

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No