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 measure
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 (if study stopped)
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
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)
Stanford, The Leland Stanford Junior University, Leland Stanford Junior University, SU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
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
Basic results (scientific)
Publication list