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

May 31, 2016 updated by: Katja Taxis, University of Groningen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 AV
        • Recruiting
        • University of Groningen
        • Contact:
          • Katja Taxis, PhD
          • Phone Number: 0031 50 3638205
          • Email: k.taxis@rug.nl
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
The intervention group will receive the pharmacist-delivered multifaceted intervention with two counselling sessions in addition to usual care.
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.
NO_INTERVENTION: Control group
The control group will receive usual care without the pharmacist-delivered multifaceted intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients adherent to medication at 3 months after discharge as assessed by the Morisky Medication Adherence Scale - 8 items
Time Frame: 3 months
3 months
Proportion of patients readmitted to hospital of any cause at 3 months.
Time Frame: 3 months
3 months
Proportion of patients dying of any cause at 3 months.
Time Frame: 3 months
3 months
Change in quality of life from baseline assessed with EuroQol questionnaire EQ-5D-3L at 3 months.
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in beliefs about medicines from baseline assessed with the Beliefs about Medicines Questionnaire (BMQ) at 3 months.
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Groningen

Collaborators

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Principal Investigator: Katja Taxis, PhD, Unit PharmacoTherapy, -Epidemiology & -Economics, Faculty of Mathematics and Natural Sciences, University of Groningen, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (ESTIMATE)

June 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-MA-ACS-Vietnam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medication Adherence

Clinical Trials on Pharmacist-delivered multifaceted intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe