*+ Overview of key study procedures - - PDF document

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• Overview of key study procedures

– Introducing the study to participants – Administering informed consent – Completing the registration document – Conducting random assignment and informing the client

• Navigating EPIS and reporting features
• Resources and next steps
• Questions & Answers

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• Potential clients may have already heard of the pilot

program, but you’ll want to recap major points of the study in everyday language to make sure clients understand. – “Washington is participating in a study to learn how services in this program help Basic Food recipients increase their skills and find jobs.” – “These results will be used to shape programs in your community and around the country to better help people reach their job goals and earn more money.”

• Stress that his/her participation in the study is important

and will help the research team figure out whether these new services actually help people or not.

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• Explain that we use a process called random

assignment to put people into one of two groups. – “Individuals who are eligible and who agree to be in the study will be placed at random into one of two groups.”

• “One group is eligible for services available through the

BFET program.”

• “The other group is eligible for BFET services plus some

additional support and training services.”

– “Random assignment is like a lottery or flipping a coin.” – “The decision about which group a person goes into is made by a computer program, so assignment to a group is purely by chance. This method keeps random assignment fair and objective for everyone.”

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• Make it clear that this is not a guarantee of receiving

services – Even if they are assigned to treatment they may not receive all services, like work-based learning. – “…may have the opportunity to receive services…”

• Don’t “under-sell” the BFET services; there are still a

large number of services available to the BFET group.

• If the individual is interested in participating, then

proceed with reading them the consent form.

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• Make it clear to the participant that their participation is

voluntary – they can still receive BFET services if they don’t want to participate

– “It is up to you whether to take part in the study.” – “If you DO take part in the study, you will have a 50-50 chance to get more education and training services than you can get now.” – “If you do NOT want to take part in the study, you will not have the chance to receive any of the new RISE pilot services, but not taking part in the study will not affect your Basic Food benefits.” – “Whatever group you are assigned to, you will be helping researchers and policymakers to learn if the new services work, and the results will help you and others in the future.”

• If the individual is interested in participating, then proceed

with reading them the consent form.

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• To administer informed consent: log into EPIS and

click the button to “Enroll a new participant.” The consent form will be the first tab you complete with the participant.

• You must read the consent form to each participant.
• Encourage participants to ask questions!
• If eligible individuals do not understand the study and

its requirements, they cannot be randomly assigned and become part of the study.

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• Explain to the participant that you will first read them

the consent form and then collect information from them by asking a set of questions. – “Now we will review the information on this consent

• form. When you sign this form, you are agreeing to

participate in this important study.” – “In a few minutes, we will ask you to tell us about such things as your education, health, employment, and use

• f public assistance. We also will ask you to give us

information about who might help us get in touch with you over the next few years, when we conduct follow-up surveys for the study. Some information is required for you to be part of the study.”

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• If working with a youth participant (ages 16-17),

determine whether the youth is the head of their own SNAP household or assistance unit.

• For youth who are not the head of their own SNAP

household or assistance unit, you will need to obtain parental consent for the youth to participate in RISE. The youth will also need to provide his or her own assent.

• For youth who are the head of their own SNAP

household or assistance unit, they can provide their

• wn consent to participate.

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• The consent form for a youth participant will look slightly

different than the consent form for an adult participant because we are required to obtain parent consent for some youth.

Consent Checkbox To be completed by: Youth – Not Head

• f Household

Youth – Head of Household Parent

“I understand the information provided and voluntarily agree to participate.”

X X

“I understand the information provided and voluntarily agree to allow my child to participate.”

X X

“I am indicating that I do NOT agree to be part of this study (or do not allow my child to participate).”

All youth or parents of youth who decline to give their consent.

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• You will likely encounter participants who are unsure if

they want to participate or decline to participate.

• You should talk to them about what aspects of the study,

pilot, or process concern them and try to alleviate those concerns.

– “If you DO take part in the study, you will have a 50-50 chance to get more education and training services than you can get now.” – “If you do NOT want to take part in the study, you will not have the chance to get any of the new RISE services, but not taking part in the study will not affect your Basic Food benefits.” – “Whatever group you end up being assigned to, you will be helping researchers and policymakers to learn if the new services work, and the results will help you and others in the future.”

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• If the person ultimately chooses not to participate:

– Reiterate that they will not be eligible to receive RISE services. – Follow your regular procedures for referring a client to BFET. – Close the case in EPIS.

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• You must read the consent form to each participant.
• You can select an English or Spanish consent form.
• Participants must be given a hard copy of the

consent form to take with them.

• Draw the participant’s attention to key information on

the consent form.

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• Work with the participant to complete the

Registration Document by reading questions out loud to the participant and filling in the answers: – “Now that you have signed the Informed Consent document, the next step in the process of enrolling you in the study is to provide study registration information. These questions ask for information on your background, such as the number of people in your household, your education, employment history, and health and contact information.”

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• If the participant has concerns about answering the questions:

– “This information is really important to the study. It will helps the study team describe the characteristics of the people who participate in the study.” – “All information collected about you will be used for study purposes

• nly. It will be kept private unless the law requires otherwise.”

– “Your name will never be used in any report written for the project. No information will be reported that in any way can identify you.” – “All people on the study team have been trained to protect sensitive information and have signed a confidentiality pledge. Any paper or computer files that contain your name, or any information that can identify you, will be kept in a locked area or secure computer

• network. Only a very small number of people on the study team will

have access to this information.”

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• See EPIS Data Variables Table

– Contact Info and Other Contact Info: If possible, update information throughout the study. – SSNs will be masked after random assignment.

• We may need to collect information about the

participant’s assistance unit number or their eJAS ID number.

• Some data fields are required and others are optional,

but optional variables are still very important!

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• After entering the participants data, complete the

Counselor tab in EPIS, which consists of two questions.

• The questions will not affect random assignment.
• This tab is not read aloud to clients. It is only for you

to complete.

• You should answer the questions as best you can,

using what you know about the client being enrolled in the study.

• There will be no consequences for you, your
• rganization, or the participants if the responses to

these questions turn out to be wrong; these data are required for research purposes only.

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• The two questions you will be asked to complete are listed below. Select an

answer to each question.

• Suppose for a moment that this person will be assigned to the RISE pilot

(treatment group). Taking into account everything you know about this person’s current barriers, and using your own intuition, how likely is this person to advance to the following components of RISE: – Strategies for Success training:

• Very Likely
• Somewhat Likely
• Somewhat Unlikely
• Very Unlikely

– Work-Based Learning (Including internships, employment, or work experience):

• Very Likely
• Somewhat Likely
• Somewhat Unlikely
• Very Unlikely

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• After completing the two questions on the Counselor tab,

proceed to the Review tab, verify all of the required information has been entered, and then click the random assignment button.

• Notify study participants of their research group using an

even tone and similar language, regardless of the group to which they are assigned. – Do NOT say, “Congratulations, you were assigned to the Treatment Group,” or “I’m sorry, you were assigned to the Control Group.” – Rather, in both situations, say, “The random assignment system has placed you in the ______ Group. This assignment means that you will get XXXX services.” Then, explain the next steps for the participant.

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• Four reports are available in EPIS:

– Enrollment Summary Report – Demographics Report – RA Group Report – Pending Random Assignments Report

• You will only see information for your organization.

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• RISE group receives meaningful amount of services

they are eligible for

• Significant contrast between services across

research groups

– Ensure BFET group does not receive RISE services – No special effort to deviate from “business as usual” for BFET participants

• Individuals retain original research group assignment

regardless of services received

– Once a control, always a control – Once in the treatment group, always in the treatment group

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• Site liaison: Julia Lyskawa (jlyskawa@mathematica-mpr.com)
• Study Help Desk

– Phone: 1-844-SNAPET1 (1-844-762-7381) – Email: SNAPETPilotEvaluation@mathematica-mpr.com

• Random assignment manual
• Frequently Asked Questions

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• Review the random assignment manual
• Complete EPIS follow-up activities with a partner
• Attend a follow-up webinar in January (if necessary)
• Contact Julia Lyskawa with questions

(jlyskawa@mathematica-mpr.com)

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