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

Not Applicable

Recruiting

• Conditions: Anticoagulants; Intention; Behavioral Symptoms
• Interventions: Other: Pharmacists' intervention

• Registration Number: NCT03670446
• Lead Sponsor: Cui Yimin

Brief Summary

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.

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 Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacists' intervention	Pharmacists' intervention	A group of participants assigned to a pharmaceutical intervention

Primary Outcome Measures

Name	Time	Method
Mental status	12 weeks	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.
anti-Xa and IIa activities	12 weeks	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.
Medication adherence	12 weeks	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.

Trial Locations

Locations (2)

China Rehabilitation Research Center Beijing Boai Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China