Pharmacist-led Intervention to Enhance Medication Adherence in Post-acute Coronary Syndrome Patients in Vietnam

Acute Coronary Syndrome Clinical Trial

Official title:

Pharmacist-delivered Multifaceted Intervention to Enhance Medication Adherence Among Post-acute Coronary Syndrome Patients in Vietnam: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02787941
• Other study ID #: PI-MA-ACS-Vietnam
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2016
• Last updated: May 31, 2016
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: May 2016
• Source: University of Groningen
• Contact: Katja Taxis, PhD
• Phone: 0031 50 3638205
• Email: k.taxis[@]rug.nl
• Is FDA regulated: No
• Health authority: Vietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial Summary

Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in several studies. Pharmacists play a significant role in enhancing medication adherence and reducing rates of mortality and re-admission to hospital by performing medication reconciliation and tailoring, and patient education. The purpose of this study is to determine the effect of pharmacist-delivered multifaceted intervention on medication adherence and clinical outcomes of post-acute coronary syndrome patients. The study will be designed as a randomised controlled trial with blinded outcome assessors. The population includes patients who survive during hospitalisation with discharge diagnosis of acute coronary syndrome. Pharmacist-delivered multifaceted intervention consists of two counselling sessions within 1 week before and after hospital discharge including medication reconciliation and tailoring, and support with pill organiser and drug information leaflet. Primary outcome measure is the proportion of patients adherent to medication at 1 month after discharge. Secondary outcome measures are the proportions of patients (1) adherent to medication at 3 months after discharge, (2) readmitted to hospital and (3) dying within 3 months after discharge. The investigators also measure (4) the change in quality of life and (5) beliefs about medicines from baseline at 3 months.

Description:

Ischemic heart disease, including acute coronary syndrome, is among the leading causes of death worldwide. Several factors have been shown to attribute to early re-admission to hospital for these conditions including comorbidities, insufficient discharge planning, lack of health literacy, and non-adherence to drug therapy. Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in several studies. Pharmacists play a significant role in enhancing medication adherence and reducing rates of mortality and re-admission to hospital by performing medication reconciliation and tailoring, and patient education. The purpose of this study is to determine the effect of pharmacist-delivered multifaceted intervention on medication adherence and clinical outcomes of post-acute coronary syndrome patients in Vietnam.

The study will be designed as a randomised controlled trial with blinded outcome assessors. Random allocation sequence will be generated using the website randomization.com. The participants will be stratified by age (<65 and 65 years or higher) and sex (male and female), and randomised into two parallel groups in a 1:1 ratio via block technique with random permuted blocks of 2, 4 or 6 patients. Investigators who perform patient recruitment and interventions will be concealed the sequence until the intervention is assigned. One group will receive usual care, called control group, while the parallel group will receive pharmacist-delivered multifaceted intervention in addition to usual care, called intervention group.

Participants will be selected from patients who present to the Cardiology Institute at Ho Chi Minh city, Vietnam. The trial will continue till achievement of sample size and 3-month follow-up thereafter. Estimated duration of recruitment is about 12 months from November, 2015 to November, 2016. The investigators will include patients who survive during hospitalisation with discharge diagnosis of acute coronary syndrome.

The intervention group will receive two counselling sessions in-person and via telephone within 1 week before and after hospital discharge. The interventions will be performed by pharmacists and include medication reconciliation and tailoring, and support with pill organiser and drug information leaflet.

Primary outcome measure is the proportion of patients adherent to medication at 1 month after discharge assessed by the Morisky Medication Adherence Scale - 8 items. Secondary outcome measures are the proportions of patients (1) adherent to medication at 3 months after discharge assessed by the Morisky Medication Adherence Scale - 8 items, (2) readmitted to hospital and (3) dying within 3 months after discharge. The investigators also measure (4) the change in quality of life assessed by the EuroQol EQ-5D-3L and (5) beliefs about medicines assessed by the Beliefs about Medicines Questionnaire (BMQ) from baseline at 3 months.

The process of data collection and management at baseline and during follow-up period is summarised in 9 steps as follows: (1) patient list review; (2) patient recruitment; (3) first data collection at baseline (data from patient interviews); (4) random allocation; (5) first counselling (intervention group only); (6) second data collection at baseline (data from medical records); (7) second counselling (intervention group only); (8) first outcome measurement (at 1 month after discharge); (9) second outcome measurement (at 3 months after discharge).

Analysis will be performed using the intention to treat principle. Reasons for dropouts and proportions for each treatment group will be reported. The investigators will compare the differences in proportions of medication adherence and rates of mortality and hospital readmission between intervention and control groups.

All patients taking part in the trial will be required to provide written informed consent at the time of recruitment. Consent form and the study protocol will be submitted to achieve approval from the Institutional Biomedical Research Ethics Committee of Cardiology Institute at Ho Chi Minh city, Vietnam. The participants will have the right to withdraw at any moment during the study period; their inclusion or exclusion from the study will not affect the usual care provided to them.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The investigators include patients who survived during hospitalisation with one of the following diagnoses according to coding of the International Classification of Diseases, 10th revision (ICD-10): unstable angina (I20.0), acute myocardial infarction (I21) or subsequent myocardial infarction (I22)

Exclusion Criteria:

• Have discharge diagnosis not unstable angina (I20.0), acute myocardial infarction (I21) and subsequent myocardial infarction (I22)

• Currently participate in another medication adherence study

• Discharge without prescription

• Unwilling to participate the study

• Unable to communicate in Vietnamese

• Unable to identify their own medications

• No telephone number

• Have cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Medication Adherence
• Syndrome

Intervention

Behavioral:
• Pharmacist-delivered multifaceted intervention
First counselling: A pharmacist performs a 30-minute in-person counselling within 1 week before discharge including: (1) assessment and giving advice on basic knowledge of acute coronary syndrome: definition, risk factors, possible cardiac events, and prevention; (2) assessment of past experiences of using medications, encouragement and tailored advice; (3) providing support with pill organiser and drug information leaflet; (4) teaching back and correcting misunderstanding. Second counselling: A pharmacist performs a 30-minute telephone counselling within 1 week after discharge including: (1) assessment of general and medication-related issues patients concerning; (2) encouragement and tailored advice; (3) teaching back and correcting misunderstanding.

Locations

Country	Name	City	State
Netherlands	University of Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University of Groningen	Ho Chi Minh City University of Medicine and Pharmacy

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items		1 month	No
Secondary	Proportion of patients adherent to medication at 3 months after discharge as assessed by the Morisky Medication Adherence Scale - 8 items		3 months	No
Secondary	Proportion of patients readmitted to hospital of any cause at 3 months.		3 months	Yes
Secondary	Proportion of patients dying of any cause at 3 months.		3 months	Yes
Secondary	Change in quality of life from baseline assessed with EuroQol questionnaire EQ-5D-3L at 3 months.		Baseline and 3 months	No
Secondary	Change in beliefs about medicines from baseline assessed with the Beliefs about Medicines Questionnaire (BMQ) at 3 months.		Baseline and 3 months	No