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Healthcare Nudging in the Development Context: an RCT in the Republic of Armenia
Last registered on June 21, 2019

Pre-Trial

Trial Information
General Information
Title
Healthcare Nudging in the Development Context: an RCT in the Republic of Armenia
RCT ID
AEARCTR-0004243
Initial registration date
June 11, 2019
Last updated
June 21, 2019 11:57 AM EDT
Location(s)
Primary Investigator
Affiliation
Zhongnan University of Economics and Law; United Nations Development Program
Other Primary Investigator(s)
PI Affiliation
University of Venice Ca'Foscari
PI Affiliation
University of Padova
Additional Trial Information
Status
On going
Start date
2019-05-06
End date
2019-07-15
Secondary IDs
Abstract
Little is known whether low-cost behavioral interventions may increase the uptake of cancer screening programs in the development context. To fill in this gap, we run a randomized controlled trial to study the impact of invitation letter and reminder manipulations on a cervical cancer screening program participation rate in the poorest region in the Republic of Armenia.
We are mainly interested in the effects of two manipulations of the invitation letters: (i) enhancing the salience of the potential negative consequences of not participating in the screening program; (ii) enforcing the importance of the checkup for the sake of one’s family members. Moreover, we are interested in assessing the effects of “treatment-specific” reminders sent a week before the screening date.
The randomized controlled trial is run by Armenia National SDG Innovation Lab (a joint initiative of the Government of the Republic of Armenia and the United Nations), in collaboration with the Ministry of Health of the Republic of Armenia. The experimental sample consists of 20800 females aged 30-60, representing roughly 50% of the target population in the region.
External Link(s)
Registration Citation
Citation
Antinyan, Armenak, Marco Bertoni and Luca Corazzini. 2019. "Healthcare Nudging in the Development Context: an RCT in the Republic of Armenia." AEA RCT Registry. June 21. https://doi.org/10.1257/rct.4243-1.0.
Former Citation
Antinyan, Armenak, Marco Bertoni and Luca Corazzini. 2019. "Healthcare Nudging in the Development Context: an RCT in the Republic of Armenia." AEA RCT Registry. June 21. https://www.socialscienceregistry.org/trials/4243/history/48451.
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Experimental Details
Interventions
Intervention(s)
We run a population-level randomized controlled trial (RCT) to understand the impact of targetted invitation letters and reminders on the take-up rate of a cervical cancer screening program implemented by the Government of the Republic of Armenia. The cervical cancer screening program is part of the "Disease Prevention and Control Project" financed by the World Bank (P128442).
Our experiment randomly assigned 20800 eligible females aged 30-60 in Shirak province to receive different invitation letters (neutral, negatively framed, concern for others) and reminders (no reminder, neutral, negatively framed, concern for others). Roughly 60% of the sample was randomly selected to receive a reminder.
The no-frame no-reminder letter constitutes the control group for our experiment.
The invitation letters are received by subjects 3 weeks before the scheduled screening week, whereas the reminders are received 1 week before. Both the letters and the reminders are sent to the postal address of each woman via registered mail through Haypost (the official national postal operator of the Republic of Armenia).
Intervention Start Date
2019-05-06
Intervention End Date
2019-06-28
Primary Outcomes
Primary Outcomes (end points)
The key outcome variable we are interested in is the participation rate in the cervical cancer screening program.
The de-identified data will be accessed through the e-health platform that contains all the necessary information: the medical history of the patient, her address, the hospital she is registered at and the doctor she is registered with. When a patient visits a specific practitioner and undertakes tests, the information is stored in the platform. This will allow us to assess, whether a given patient visited her general practitioner and undertook the screening test or not.
During the experiment the Health Project Implementation Unit distributed participation lists to the practitioners and asked them to fill in the names of the patients who visited the medical institution with the primary aim to take part in the screening program. We will also be given access to these de-identified data.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The aim of our experiment is fewfold:

a) First, we want to assess the effect of specific manipulations of the invitation letter format on the take-up rate of the cervical cancer screening program.
b) Second, we strive to understand the impact of reminders on the take-up rate of the cervical cancer screening program.
c) Third, we want to uncover the most optimal letter-reminder combination.

a. Invitation letter

We tested three versions of the invitation letters:

-Neutral (slightly positive)
-Enhanced loss frame
-Concern for others

The "Neutral" letter informes the recipient about the screening program, the scheduled screening date and provides very brief information about the positive effects of participating in the screening.
Unlike the "Neutral" letter, the "Negatively Framed" letter provides the recipients with extended information about the negative consequences of not participating in the screening program. The rest of the information is exactly the same as that in the neutral letter.
Everything else the same, the "Concern for Others" letter replaces the negative information with a concern for others message, manipulating the social preferences of the recipients. More specifically, the letter asks the recipients to participate in the screening program for the sake of their loved ones, who expect them to live a happy and long life.

b. Reminders

The content of the reminders is exactly the same as that of the invitation letters. Roughly 60% of the sample is randomly selected to receive a reminder.

Overall, the RCT consists of 8 treatments.
1. Negatively framed letter- No reminder (N=2600)
The patients in this treatment received a negatively framed letter and no reminder.
2. Negatively framed letter- Negatively framed reminder (N=2600)
The patients in this treatment received a negatively framed letter and a negatively framed reminder.
3. Concern for Others Letter- No reminder (N=2600)
The patients in this treatment received an other-regarding letter and no reminder.
4. Concern for others Letter- Concern for Others reminder (N=2600)
The patients in this treatment received an other-regarding letter and an other-regarding reminder.
5. Neutral Letter- No reminder (N=2600)
The patients in this treatment received a neutral letter and no reminder.
6. Neutral Letter-Negatively framed reminder (N=2600)
The patients in this treatment received a neutral letter and a negatively framed reminder.
7. Neutral Letter- Neutral reminder (N=2600)
The patients in this treatment received a neutral letter and a neutral reminder.
8. Neutral Letter-Concern for Others Reinder (N=2600)
The patients in this treatment received a neutral letter and an other-regarding reminder.

We will also have access on subjects not involved in the RCT (i.e, not receiving invitation letters) from the population health registers.
Both the letters and the reminders were disbursed via registered mail. The letters were received 3 weeks prior to the screening date, whereas the reminders were received 1 week prior to the screening date. The RCT was implemented in Shirak province between May-July, 2019 in collaboration with the Ministry of Health of the Republic of Armenia, United Nations Development Program in Armenia and Armenia National SDG Innovation Lab (joint initative of the Government of the Republic of Armenia and the United Nations). Shirak province was chosen for fewfold reasons. First, Shirak is the most economically disadvantaged region of the Republic of Armenia. Thus, if cancer is detected at later stages, the majority of the population cannot afford the high treatment costs. Under these circumstances, early detection of potential cancer is of vital importance. Second, the participation rate in the cervical cancer screening program in this region was one of the lowest in the country before the experimental intervention .
Experimental Design Details
Randomization Method
Randomization was carried out by the reseachers in office using STATA 15. The seed was set to 123456789.
Randomization Unit
We carried out Individual level randomization for both the treatment group each subject should be exposed to and for the timing of letter delivery (i.e., week of invitation).
Allocation to treatment group was stratified by general practitioners to make sure that there was full support by the general practitioners. Hence, the analysis will be conditional on GP fixed effects, but there is no need to cluster by GP since the randomization is done individually.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
The RCT was not clustered.
Sample size: planned number of observations
The representative sample contains 20800 females aged 30-60 randomly selected from the population of eligible females in Shirak province. The 20800 individuals were randomized into 8 treatments with 2600 subjects in each treatment.
Sample size (or number of clusters) by treatment arms
Overall population of eligible females in Shirak province: roughly 42000 females aged 30-60.
Randomly selected for the study: 20800 females aged 30-60.
Number of treatment arms: 8
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Assuming a standard deviation of the outcome of 0.259 (currently observed in the Armenian population), we estimate a minimum detectable effect with power 0.8 and significance 0.05 for pairwise comparison of the take-up rate across any two treatment groups of the size we have allocated (2600 subject per group) of 2.01 percentage points (we assume two-tailed tests are being carried out). A higher MDE is obtained if we consider that letters may fail to be delivered or the standard deviation of the outcome may be higher.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Ethical Committee of the Department of Economics, Ca'Foscari University of Venice
IRB Approval Date
2019-03-13
IRB Approval Number
N/A
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