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African Health Markets for Equity (AHME) IMPACT EVALUATION
Last registered on February 11, 2014

Pre-Trial

Trial Information
General Information
Title
African Health Markets for Equity (AHME) IMPACT EVALUATION
RCT ID
AEARCTR-0000217
Initial registration date
February 07, 2014
Last updated
February 11, 2014 3:25 PM EST
Location(s)
Region
Primary Investigator
Affiliation
University of California, Berkeley
Other Primary Investigator(s)
Additional Trial Information
Status
In development
Start date
2013-07-24
End date
2017-10-31
Secondary IDs
Abstract
The African Health Markets for Equity (AHME) Impact Evaluation aims to rigorously evaluate the extent to which transforming the business model of franchised healthcare providers and expanding access to demand-side financing generates effective and cost-effective coverage of priority technologies and interventions amongst the poor. The evaluation is a collaborative effort between Innovations for Poverty Action and researchers from multiple institutions, and is funded by the Bill and Melinda Gates Foundation and the Department for International Development of the United Kingdom of Great Britain and Northern Ireland (DFID). The AHME intervention package will seek to improve efficiencies in private health care delivery by reducing both supply-side and demand-side constraints. Specifically, supply-side intervention will include (1) the social franchising of private clinics in order to improve consistency and quality of care and to reduce costs and (2) quality monitoring linked to capital financing in order to help clinics expand and improve clinical services. On the demand side, AHME interventions, such as vouchers, health insurance schemes and medical savings accounts will be integrated into the AHME package in later years to reduce financial barriers to accessing provider services. In addition opportunities to improve the operational efficiency of supply and/or demand-side financing interventions using information and communication technology (ICT) interventions will be explored.

The AHME intervention package will be evaluated using a randomized control trial (RCT) design. The RCT will be designed to measure the effectiveness and cost-effectiveness of the AHME model (franchising, supply-side financing and demand-side financing) at improving quality of care, service utilization, access to high-quality care, and health outcomes. Clinics will be screened for eligibility during baseline data collection. Using criteria established by the AHME implementing partners, clinics will be grouped by how likely they are to be eligible for the AHME package of interventions. Clinics in top eligibility tiers (those most likely to be eligible for the package of AHME interventions) will be randomly assigned a number to determine the order in which they will be approached for recruitment into AHME. Random assignment will be stratified by county and eligibility tier. The top half of the list will be assigned to the treatment group (clinics that should be approached for recruitment to the AHME package immediately) and the control group (clinics that will be recruited after the completion of the AHME evaluation). The random number assigned to each clinic will also determine the order in which clinics will be approached within both treatment and controls arms. Subsequent interventions (i.e., demand-side financing and information and communication technology interventions) will be randomly allocated in a similar fashion. Data will be collected over a 4 year period at both the clinic and household level to measure healthcare utilization and quality of care, clinic financial outcomes, and child health outcomes. Outcomes will be compared between treatment and control clinics to estimate impacts of the overall AHME package. Cost-effectiveness analyses will also conducted






External Link(s)
Registration Citation
Citation
GERTLER, PAUL. 2014. "African Health Markets for Equity (AHME) IMPACT EVALUATION." AEA RCT Registry. February 11. https://doi.org/10.1257/rct.217-2.0.
Former Citation
GERTLER, PAUL. 2014. "African Health Markets for Equity (AHME) IMPACT EVALUATION." AEA RCT Registry. February 11. https://www.socialscienceregistry.org/trials/217/history/1056.
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Experimental Details
Interventions
Intervention(s)
The AHME package is a set of interventions that seek to improve private health care delivery inefficiencies by integrating supply- and demand-side interventions. The primary focus of the supply-side interventions will be to improve and expand the delivery of high quality health care services through a private network of providers. In the first stage of the supply-side intervention, AHME implementation partners Marie Stopes International (MSI) and Population Services International (PSI) will expand the scope and scale of their existing franchise model. MSI and PSI will expand the scope of existing family planning services to include: maternal and perinatal care, and malaria, diarrhea, and pneumonia treatment services for children less than 5 years old (with plans to add child nutrition and TB services in later years). In addition, MSI and PSI will expand the scale of their services to include new private clinics in both Eastern and Western Kenya. MSI and PSI will recruit new providers (private clinics) to their respective franchise models and provide training and support in franchised services (e.g., clinical protocols and clinical best practices), subsidize select clinical materials, and provide marketing (branding and community demand generation messaging). As part of their recruitment into the MSI and PSI franchises, private clinics agree to maintain records that MSI/PSI can monitor for quality assurance (annual visits), abide by price limits for services and materials, and pay membership fees. The franchise intervention will be rolled out in the first year of the intervention among randomly selected clinics; the order in which treatment clinics are recruited by MSI and PSI will also be randomized.

In conjunction with franchising efforts, PharmAccess will roll out its "SafeCare"/Medical Credit Fund (MCF) intervention to MSI/PSI franchisees. The goal of the SafeCare/MCF intervention is to first improve quality assurance systems within clinics by providing clinics with a quality improvement plan based on observed operations. The SafeCare process includes a monitoring system with step-based certificates to reward clinic quality improvements. As clinics achieve "higher" steps (improve quality) they will become eligible for MCF loans. It is expected that increased access to capital will allow providers (private clinics) to make the necessary investment to further improve the quality and range of services they offer.

Demand-side financing (DSF) and information and communication technology (ICT) components of the AHME package will be randomly overlayed franchising and supply-side financing interventions in later years of the evaluation. DSF interventions could include vouchers, health insurance schemes, and medical savings accounts.
Intervention Start Date
2014-10-16
Intervention End Date
2017-10-31
Primary Outcomes
Primary Outcomes (end points)
The key outcomes of interest will be: (1) provider quality, (2) cost of care (the amount that is charged for services, the share of patients that receive discounts and the cost of care, including cost of services, travel and medicines, etc., reported by patients in the household survey), (3) client load by service categories, (4) patient utilization through self-reported care-seeking behavior in the household survey, (5) facilities’ revenues and costs, (6) management practices (record-keeping, supply-chain management practices, human resource management practices, etc.), and (7) integration with financial institutions (access to formal loans and collaboration with insurance providers) and (8) market impacts. While we are not powered to measure child health impacts, we will also collect health outcomes among children <5 years in households that accessed clinics services during baseline. Health outcomes will include: summary health measures such as weight-for-height, height-for-age and mid upper arm circumference; self-reported symptoms for diarrhea, acute respiratory illness, and malaria; in addition, health measures may include assessment of anemia using a finger prick test for hemoglobin and RDTs for malaria.
Primary Outcomes (explanation)
A note on facility quality:
Facility quality will be measured along several dimensions, including: (1) structural quality (e.g. hand-washing stations, proper storage of medicines, etc.), (2) provider knowledge of appropriate clinical practices for key disease areas prioritized by AHME (measured through medical vignettes, or hypothetical medical cases, in which providers say what actions they would take), and (3) provider adherence to appropriate clinical protocols in these disease areas (most likely to be measured through direct observation).

Client perception of quality (e.g., general perceptions of quality, whether they were treated nicely, whether they waited long for service, etc.) and client-reported adherence to appropriate clinical protocols (measured by asking about provider actions taken during visits) will be measured in the household survey.

A note on market impacts:
Market impacts will be measured by (1) entry and exit of competitors to the clinics in the evaluation sample and (2) patient switching patterns. To measure entry and exit, the research team will map out all providers within a certain distance of treatment and control providers and will collect the name and location of other facilities used by households in our survey in order to identify competitors to clinics in the evaluation sample. In follow-up rounds of the survey, we will again map the area and measure entry and exit of competitors. We will measure switching patterns among current patients (patients that began using clinics prior to the introduction of AHME) during follow-up rounds of the household survey. We will also refresh the household sample in each of the follow up surveys conducted in 2015 and 2016. We will ask new clients about their care-seeking behavior prior to visiting the clinic of interest in the evaluation sample (if they sought care before and where if so). As a result, we will be able to determine whether new clients are switching from public facilities, switching from other private facilities or entering the healthcare system for the first time.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The overall impact of the AHME package of interventions will be estimated using a randomized control trial design (RCT). During baseline data collection, clinics in counties throughout Eastern and Western Kenya will be mapped and screened by Innovations for Poverty Action (IPA), using established MSI and PSI criteria and protocols. Clinics that are considered "likely" to be eligible are assigned a randomly generated number by the investigators in order to 1) assign clinics to intervention (early recruitment), or control (recruitment at the end of the study) and 2) determine the sequence in which clinics are approached to be recruited for franchising and SafeCare/Medical Credit Fund by the implementation partners. In Year 1, after baseline clinic data collection, and randomization are complete, MSI and PSI will approach clinics for final determination of franchise eligibility and for recruitment. SafeCare/MCF interventions will also be rolled out in Year 1 as part of the AHME package and will follow the same recruitment order as that used for franchising recruitment. In Year 2, treated clinics will receive demand-side financing interventions when PSI and MSI provide training and support to their franchised clinics to register with NHIF and to improve clients’ experience in using NHIF at their clinics.

Four rounds of data collection will be used to measure baseline characteristics, and evaluation outcomes. In Year 1 (Q4: 2013) baseline surveys will be conducted in all clinics. In addition, clinic exit surveys will be used to identify and collect contact information from a sample of clinic clientele, and ask permission to visit their homes to conduct a baseline household interview. In Year 2 (Q1: 2015), follow up surveys will be conducted in all clinics to measure intermediate clinic outcomes, and to monitor intervention implementation. In Years 3 and 4 (Q1: 2016; Q1: 2017) full follow ups surveys will be conducted in all clinics and all households to measure longer-term impacts of the AHME package and to measure incremental impacts of DSF and ICT interventions.

This randomized design will allow us to directly compare outcomes in the intervention and control arms, and identify the effect of the intervention. Since not all clinics will agree to be franchised, or participate in SafeCare/MCF, intention-to-treat (ITT) principles will used to identify an unbiased effect of offering the package to the clinic. The effect of the treatment on the treated will be estimated by using an instrumental variables approach. In addition, randomizing the order in which clinics are approached for the intervention packages will allow us to estimate "dose responses", as different clinics will be on treatment for different amounts of time at each follow up round.
Experimental Design Details
Randomization Method
Clinics will be assigned a random number between 0 and 1 by an investigator (STATA 13). A clinic’s random number will determine the order in which clinics will be visited for recruitment to AHME and whether a clinic is assigned to treatment or control. Clinics in the top half of the visit order list are assigned to the treatment group and will be recruited for AHME immediately, and clinics in the bottom half of the visit order list are assigned to the control group and will be visited only after the study is complete.

Randomization will be stratified by clinic size, eligibility tier and county. All clinics that are alone in their strata (for example, if there is only 1 medium-size clinic in the highest eligibility tier in a given county) will instead be stratified by size, eligibility tier and by region (Eastern or Western Kenya) rather than by county.

Within the treatment group, the AHME implementing partners will visit clinics according to (1) “how eligible” they are (i.e. clinics that meet all of the eligibility criteria are visited first, those that meet most of the criteria are visited next, those that meet fewer of the criteria are visited third, etc.) and (2) the order determined by the random number initially assigned to each clinic.
Randomization Unit
Randomization will occur at the individual clinic level; households will be sampled from and clustered at the clinic level.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
The final sample size is to be determined. As of January 2014, we have randomized 1,528 clinics into the treatment arm and 1,475 clinics into the control arm. However, we will eliminate from both arms clinics that are less likely to be eligible, because we expect take-up rates among this group to be very small. The precise eligibility level at which we will cut clinics from the sample is to be determined. We anticipate the final clinic sample size to be between 800 and 1,200 clinics, with roughly half of the clinics in treatment and half in control. Procedures for eliminating clinics from the sample will be identical in treatment and control arms.

Households will be clustered at the clinic level. We will identify, sample and enroll approximately 10,000 households in the study from clinic exit interviews, of which approximately 5,000 will be from treatment clinics and 5,000 will be from control clinics.
Sample size: planned number of observations
Approximately 1500 clinics, and 10,000 households.
Sample size (or number of clusters) by treatment arms
The final number of observations that will be used in the study is to be determined. As of January 2014, we have collected data on 3,003 clinics that have been randomized into treatment and control arms (1,528 and 1,475, respectively). However, we will eliminate from both treatment and control arms clinics that are less likely to be eligible. The precise eligibility level at which we will cut clinics from the sample is to be determined. We anticipate the number of observations to be between 800 and 1,200 clinics (with roughly half in treatment and half in control). Procedures for eliminating clinics from the sample will be identical in treatment and control arms.

We will enroll approximately 10,000 households in the study, of which approximately 5,000 will be from treatment clinics and 5,000 will be from control clinics.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Kenya Medical Research Institute (KEMRI)
IRB Approval Date
2014-06-12
IRB Approval Number
NCST/RCD/12A/013/68B
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers