Condition category
Haematological Disorders
Date applied
11/01/2011
Date assigned
31/01/2011
Last edited
15/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Scott Rozelle

ORCID ID

Contact details

616 Serra Street
Encina Hall
East Wing
Room 402
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Paying-for-performance and cost effectiveness of strategies to combat anaemia in China: an interventional, multicentre cluster-randomised trial

Acronym

Study hypothesis

To study the impact of financial incentives to primary school principals on anaemia reductions among students in rural China.

As of 15/03/2011 the target number of participants for this study has been increased from 2,957 to 3944

Ethics approval

Stanford University Human Subjects Research Institutional Review Board approved on the 21st July 2009 (ref: 17071)

Study design

Interventional multicentre cluster-randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Iron deficiency anaemia

Intervention

Information only:
To some randomly-assigned schools we provided three types of information to school principals:
1. The share of enrolled students who are anaemic
2. Descriptions of efficacious methods for reducing anaemia (including vitamin supplementation, lunch fortification, and other dietary changes as well as the possible role of educating parents about anaemia)
3. Details about anaemia's relationship to school attendance, educational performance, and cognitive development as reported in peer-reviewed academic studies

Information and earmarked operating budget subsidy (hereafter termed "Subsidy" for
simplicity):
Because purchasing inputs to reduce anaemia may be difficult given current operating budgets (which have little discretionary funds available), we randomly assigned some schools to receive earmarked operating budget subsidies. The subsidy schools were given 1.5 RMB per student per day, an amount that was enough to buy two to three ounces of red meat if the entire amount was spent on red meat. These subsidies are only allowed to be used for nutrition-related expenses.

However, it is always possible that other components of a school budget could be re-allocated, effectively resulting in subsidies being used for other more highly prioritised purposes (if a school's own nutrition spending fell in response to the subsidy); we investigate this possibility directly. In addition, we provide exactly the same information to principals as in Information only schools.

Information and earmarked operating budget subsidy and anaemia reduction incentive
(hereafter termed "Incentive"):
To test the effectiveness of direct rewards for health improvement, we randomly assigned a third group of school principals to receive performance payments for reductions in anaemia among their student populations. Given the governance structure of Chinese primary schools, school principals make executive decisions about school operations (National People's Congress 1995).

Incremental incentive payments were linear in the absolute reduction in students with anaemia (150 RMB per student) between baseline and follow-up. The amount 150 RMB was chosen to equal roughly two months of salary (3000 RMB) if the principal was successful in reducing the number of students with anaemia by 20 students – a feasible reduction according to our early pilot experience. These schools also received the same information and subsidies as in the Information only and Subsidy schools.

Control Group (Added 15/03/2011):
No intervention in these schools.

The treatment lasted 6 months. The evaluation survey was done over the course of a week.

As of 15/03/2011 the trial record has been updated to include an additional control group.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Haemoglobin concentrations, obtained by finger prick testing using HemoCue AB point-of-care diagnostics, measured during the evaluation survey, six months after the start of the treatment

Secondary outcome measures

Measured during the evaluation survey, six months after the start of the treatment:
1. Differential approaches of principals to reduce anaemia
2. Changes over time in the composition of meals at home (meat, tofu, and fruit)
3. Changes in school budgetary allocations in both the Subsidy, Incentive and Information only groups relative to the Control group

Overall trial start date

10/01/2009

Overall trial end date

06/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All fourth and fifth grade students (both male and female students ages 8 - 11 years) in 57 randomly selected rural primary schools in ten nationally designated poor counties in China's Ningxia and Qinghai provinces.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3,944 (2,957 at time of registration)

Participant exclusion criteria

1. Students found to be extremely anaemic were excluded and sent to a clinician for treatment
2. Students identified as having thalassaemia

Recruitment start date

10/01/2009

Recruitment end date

06/04/2010

Locations

Countries of recruitment

China

Trial participating centre

616 Serra Street, Encina Hall
Stanford
94305
United States of America

Sponsor information

Organisation

Stanford University (USA)

Sponsor details

450 Serra Mall
Stanford
94305
United States of America

Sponsor type

University/education

Website

http://www.stanford.edu/

Funders

Funder type

Research organisation

Funder name

International Initiative for Impact Evaluation (3ie), Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stanford University (USA)

Alternative name(s)

SU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes