Clinical trial NCT03670446: Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
Official title: Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anticoagulants
Intention
Behavioral Symptoms
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication adherence
timeFrame: 12 weeks
measure: Mental status
timeFrame: 12 weeks
measure: anti-Xa and IIa activities
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Rehabilitation Research Center Beijing Boai Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: