Study aimed at making community-based health insurance benefits more accessible to the poor

ISRCTN	ISRCTN37056185
DOI	https://doi.org/10.1186/ISRCTN37056185
ClinicalTrials.gov number	NCT00421629
Secondary identifying numbers	067926; PHHPBD25

Submission date: 25/06/2007
Registration date: 25/06/2007
Last edited: 16/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study aimed to identify ways of making the benefits of a health insurance scheme in Gujarat, India, more accessible to its poorest members. Normally, in order to be eligible for reimbursement under this insurance scheme, a member had to be hospitalized, had to pay for her hospitalization out-of-pocket, and then had to submit an insurance claim. Research we conducted in 2003 suggested that the poorest members of this insurance scheme were the least likely to benefit from it. Among the problems they faced were jobs and responsibilities that prevented them from seeking hospitalization, and difficulties paying for hospitalization. This study involves testing two different interventions intended to make health insurance benefits more accessible.

Who can participate?
All female and male members of SEWA insurance for 2004 and 2005.

What does the study involve?
One intervention involves paying the insurance benefits upfront when the woman was admitted to hospital, rather than by reimbursement. The second intervention involves strengthening contacts between members and administrators, to make the process of submitting a claim easier and less expensive. Participants are randomly allocated to either the first intervention, the second intervention, or the two interventions together.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
October 2003 to April 2006

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Prof Anne Mills
anne.mills@lshtm.ac.uk

Contact information

Prof Anne J Mills
Scientific

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

ORCID ID	0000-0001-9863-9950
Email	anne.mills@lshtm.ac.uk

Study information

Study design	Health services research, randomised, open label, active control, factorial assignment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title	Experimental study to assess interventions aimed at improving the equity impact of community-based health insurance
Study objectives	Community based health insurance is often cited as a means of improving access and financial protection in developing countries, but such schemes may not benefit the poorest. We evaluate alternative strategies for improving the uptake of benefits of a community based health insurance scheme by its poorest members. The purpose of this study is to assess interventions aimed at improving the distributional impact of a community based health insurance scheme in rural India.
Ethics approval(s)	Received from the local medical ethics committee on 15/03/2003, ref: 948
Health condition(s) or problem(s) studied	Health insurance
Intervention	Three groups are compared to standard insurance scheme members (control): 1. Group one is provided with After-Sale Service and supportive supervision (AfterSS) 2. Group two is provided with Prospective Reimbursement (PR) 3. Group three is provided with these two interventions together (both)
Intervention type	Other
Primary outcome measure	Socioeconomic status of claimants relative to the membership base in their subdistricts of residence.
Secondary outcome measures	1. Enrolment rates in Vimo SEWA 2. Mean socioeconomic of the insured relative to the general rural population 3. Rate of insurance claim submission
Overall study start date	01/10/2003
Completion date	01/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	688
Key inclusion criteria	Subdistrict inclusion criteria: 500 or more female (greater than or equal to 18 years of age) Self Employed Womens Association (SEWA) insurance members in 2003. Individual inclusion criteria: All female and male members of SEWA insurance for 2004 and 2005.
Key exclusion criteria	Subdistrict exclusion criteria: 1. All members were mandatorily enrolled in the scheme by a donor agency 2. The sub-district had no general hospital of 25 beds or more Individual exclusion criteria: Those whose home could not be found based on given address data.
Date of first enrolment	01/10/2003
Date of final enrolment	01/04/2006

Locations

Countries of recruitment

England
India
United Kingdom

Study participating centres

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Self Employed Women's Association

SEWA Reception Centre
Opp. Victoria Garden
Bhadra
Ahmedabad
380 001
India

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
Hospital/treatment centre

Keppel Street
London
WC1E 7HT
England
United Kingdom

Email	anne.mills@lshtm.ac.uk
Website	http://www.lshtm.ac.uk/
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Charity

Wellcome Trust (UK) (grant ref: 067926)
Private sector organisation / International organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	challenges to trial results:	01/01/2006	Yes	No
Results article	results	01/02/2006	Yes	No
Results article	barriers to trial results:	01/03/2006	Yes	No
Results article	preferred provider system results:	01/09/2006	Yes	No
Results article	equitable utilisation results:	23/06/2007	Yes	No
Results article	measuring improved targeting results:	01/07/2007	Yes	No
Results article	management initiatives results:	01/10/2007	Yes	No