Effectiveness of A Health Microinsurance Scheme for Private Primary Care in Malaysia (HMI)

March 9, 2016 updated by: Muralllitharan Munisamy, Chulalongkorn University

Effectiveness of A Health Microinsurance Scheme in Improving Health Equity and Clinical Outcomes for Private Primary Care in Kuala Lumpur, Malaysia

This is the Phase 3 of a 3 phase study to determine the feasibility, acceptability and effectiveness of a health microinsurance scheme in improving health equity and clinical outcomes for private primary care (PPC) in Kuala Lumpur, Malaysia. This two-arm, pre-post, quasi-experimental trial consisted of utilizing a HMI scheme (experimental clinic) and normal OOP payments (control clinic) for 6 months. The HMI scheme enabled subscribed households to access a defined benefit package at a selected PPC for treatment and follow-up.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

This will be a quasi-experimental study designed to determine the effectiveness of a community health microinsurance scheme (HMI) in private primary care clinics in Malaysia via a pre-post study of an experimental and control clinic. A proposed HMI scheme, whose price and benefit package have been defined through the earlier Phases 1 and 2, will be accessible to subscribed households at the experimental clinic, while the control clinic has subscribed patients paying as per normal practise, which is by Out-Of-Pocket payment. The HMI scheme enabled subscribers to visit the selected clinic chosen for any form of primary care diagnosis, treatment and follow-up. Both the clinics are located in the Jalan Ipoh area, a suburb of Kuala Lumpur, and have common sociodemographic characteristics. A pre-intervention questionnaire will aim to capture health seeking behaviour, delay in seeking medical care, monthly health expenditure and improvements in clinical outcome (assessed by clinical test results). After six months, a post-intervention questionnaire is administered again to the respondents which then allows assessment of the outcome variables.

Study Type

Interventional

Enrollment (Anticipated)

114

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.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Households were located in the study area
  2. Method of payment to clinic is by out-of-pocket
  3. This is household's regular choice of primary care provider.
  4. Patient has been seen in the clinic since at least the past two years i.e from before Jan 1, 2014

Exclusion Criteria:

  1. Households had members who died in the year 2014.
  2. Households had members who were away from this place of residence for work/transferred for more than 1 month in 2014.
  3. Households had members who had regular follow-up in public facilities for chronic disease.
  4. Households with members who have switched methods of payment in the last year- (e.g newly bought insurance or retired and lost health benefits so paying OOP)
  5. Patients who refuse consent

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Microinsurance Scheme
Households owning the HMI package, entitling them to visit and receive treatment from the selected primary care clinic
A defined priced package of primary care services, including investigation and treatment such as procedures and medication, available at a selected clinic for 6 months
Other Names:
  • Health Microinsurance Scheme
No Intervention: Out-Of-Pocket
Households who visit the selected primary care clinic, but pay by Out-Of-Pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-seeking behavior
Time Frame: Change from Baseline health seeking behavior at 6 months
Delays in seeking healthcare (days)
Change from Baseline health seeking behavior at 6 months
Monthly health expenditure
Time Frame: Change from Baseline Monthly Health Expenditure at 6 months
How much has been spent for monthly health expenses (in Ringgit Malaysia)
Change from Baseline Monthly Health Expenditure at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome of Diabetes Mellitus
Time Frame: Change from Baseline HbA1c at 6 months
Measurement of HbA1c
Change from Baseline HbA1c at 6 months
Clinical Outcome of Hypertension
Time Frame: Change from Baseline Resting Mean Blood Pressure at 6 months
Resting mean blood pressure
Change from Baseline Resting Mean Blood Pressure at 6 months
Clinical outcome of dyslipidemia
Time Frame: Change from Baseline serum cholesterol and LDL at 6 months
Total serum cholesterol and LDL
Change from Baseline serum cholesterol and LDL at 6 months
Clinical outcome of bronchial Asthma
Time Frame: Change from Baseline spirometry levels at 6 months
Spirometry levels
Change from Baseline spirometry levels at 6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Dr Murallitharan Munisamy, College of Public Health Sciences Chulalongkorn University

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

April 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • NMRR 29311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Study Data/Documents

  1. Study Protocol
    Information comments: Username: HMI Password: insurance Total protocol FILE named protocol.pdf
  2. Informed Consent Form
    Information comments: Username: HMI Password: insurance Patient Information Sheet and Consent forms in English and Bahasa Malaysia
  3. Questionnaires
    Information comments: Username: HMI Password: insurance All questionnaires (English) uploaded

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.

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