1 0906-0092 1_Program Eligiblity Protocol (Redline 0730202

OMB No: 0906-0095

Expiration Date: 7/31/2027

Public Burden Statement: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The OMB control number for this information collection is 0906-0095 and it is valid through 7/31/2027. This information collection will be used to assess nominated ECHV programs’ interest in and eligibility for participation in the Assessing and Describing Practice Transitions Among Evidence-Based Home Visiting Programs in Response to the COVID-19 Public Health Emergency (ADAPT-HV) study. The time required to complete this information collection is estimated to average less than 1 hour per response, including the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection. This information collection is voluntary and confidentiality is followed according to law. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: HRSA Information Collection Clearance Officer, 5600 Fishers Lane, Room 14N39, Rockville, MD or [email protected].

Program Eligibility Protocol

Introduction

[Note: if we have already had informal conversations with this respondent via phone or email, we will skip any elements of the introduction script that have been covered previously.]

My name is [NAME] and I work with The Policy & Research Group (PRG). On behalf of the Health Resources and Services Administration and in partnership with Administration for Children and Families, we are conducting a study that seeks to identify and test changes in home visiting practices in response to the pandemic that have the potential to improve home visiting services in the future. This study focuses on identifying and testing strategies for coaching caregivers to promote positive caregiving skills.

Coaching refers to a practice in which the home visitor supports caregiver-led, child-directed skills or activities through verbal guidance or direction. This is in contrast to other approaches such as modeling strategies, when the home visitor demonstrates skills or activities while families observe. We want to identify and discuss strategies that enable more effective uses of coaching –when that technique is appropriate–in order to improve services. Examples of related activities include videos of parent-child interaction for review by home visitors and parents (either synchronous during visits or asynchronous through text) and reflective supervision with home visitors about ways to increase coaching during visits. I will refer to these strategies as “coaching strategies.”

We plan to conduct the study using a rapid cycle learning framework. This framework provides an opportunity to identify practices of interest, then improve and deliver them as defined strategies that, eventually, can be scaled across other programs and contexts. The study will take between six and eight months to complete from start to finish; we aim to start the study in [start date]. Right now, we are talking to a range of organizations and collecting information on programs that might be a good fit for the study; we will invite programs to participate in the study after these initial conversations.

The purpose of this discussion is to ask you some questions about your organization and services to determine whether they are well suited to be included in the study. After explaining the study process in more detail, we want to gauge your interest in participating in the study. If you are a good fit and want to participate, we will work closely with you (and any other members of your leadership team who should be involved) to jointly complete a study agreement that lays out roles and responsibilities. Regardless of whether you participate in the study, we would like to provide your program with $100 as a token of our appreciation for your time and participation in this initial discussion.

If you are selected and want to participate, the study has potential benefits to you, other programs like yours, and the clients you serve. Primarily, the study will serve as an opportunity to build knowledge and refine guidance on strategies implemented by home visiting programs to promote engagement and active participation in virtual visits. Ultimately, the study aims to improve the services offered to families. All programs participating in the study will receive a site payment of $1,500 for their participation.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. This information collection has been approved under OMB information collection request [OMB number], which expires on [expiration date].

This conversation should take about an hour. Your participation in this information-gathering conversation is voluntary and you have the right to refuse any question. You may end the conversation at any point. There is no penalty if you choose not to participate in this conversation. There are no risks or benefits to your participation in this conversation. If you decide you are interested in participating in the study, we will use the information you provide today to help us make decisions about which programs to ultimate recruit. As such, we may share specific details about your program with HRSA staff members who are part of the ADAPT-HV team during conversations about recruitment. Although your name will not be used in connection with this information, it may be possible to attribute these details to you given your role as a program administrator and other information about your program.

With your permission, I’d like to record this conversation. The recording is simply to supplement our notes as we gather information about your program; it will not be transcribed or shared with anyone outside of the ADAPT-HV study team. The recording will be stored securely and will be deleted at the end of the study. Do I have your permission to record?

Before we begin, do you have any questions about the project? Do you agree to participate in this discussion?

[If permission is granted, begin recording.]

Part 1: Respondent Background

To get started, I’ll ask a few questions about you and your role at [program].

Question: What is your job title?

• Follow-up: How long have you been working at [organization name]?

• Follow-up: What are your main responsibilities at [organization name]?

Part 2: Program Background

[Note: In some cases, we may have already collected some of this information through informal conversations with federal staff or program staff, or through preliminary research conducted to identify potential programs to recruit. If that is the case, we will use the information already collected under that effort, and we may ask respondents to confirm the accuracy of previously collected information, but we will not ask respondents to repeat information.]

Now I’d like to get some background information about the home visiting services offered by your program.

Question: Where does your program operate?

Question: What home visiting model or models does your program implement?

• Follow-up: how long the organization has been implementing the model

Question: How many families does your program have the capacity to serve?

• Follow-up: How many families are you currently serving?

• Follow-up: How many home visitors are currently on the team?

• Follow-up: What is the current average caseload for home visitors working at [organization]?

  • Probe: maximum caseload for home visitors working at [organization]

• Follow-up: About how many home visits do home visitors typically schedule/complete in a week? How much does this vary?

• Follow-up: How many home visits does each family receive per [week, month], on average?

I have a few questions about the population served by your home visiting program.

Question: Who does your program aim to serve?

• Follow-up: Are there communities that you would like to serve but have not engaged?

  • Probe: age, race/ethnicity, income, location (including urbanicity)

• Follow-up: Are there any cultural or community contexts of the families you typically serve that influence the services you provide?

  • Probe: lack of daycare centers in the community; families cautious of being video or audio recorded

Part 3: Program Eligibility

Next, I have some questions about how services are being implemented at your program to determine whether your current processes are a good fit for the study.

Question: In what circumstances do you currently deliver services virtually? By virtual visits, for purposes of this study, we mean a video-based home visit conducted in real time with a caregiver and child. The visit may be conducted using a smartphone, tablet, or computer, as long as the device allows for video-based interaction.

• Follow-up: What considerations do home visitors make when scheduling virtual services as opposed to in-person services?

  • Probe: services that can and cannot be delivered virtually

  • Probe: home visitors’ capacity and technological capabilities

Follow-up: How frequently do home visitors deliver services virtually? What proportion of services would you say home visitors deliver virtually?

Question: What is the mode of delivery for virtual services (i.e., phone, tablet, computer)?

• Probe: how often the mode differs for home visitors versus families

• Follow-up: Do most families you serve have the technological capacity to participate in virtual services?

  • Probe: access to a computer or tablet with a camera for all families; access to adequate internet or Wi Fi for all families; adequacy of phones for video services; support provided for families to participate in virtual services

• Follow-up: When home visitors have in-person sessions what type of devices or technological capabilities do they typically have? (e.g., internet connection, tablet, laptop, cell phone)

Question: Are there any additional important family, cultural, community, or program-specific contexts that we should be aware of that may influence a family’s ability to effectively participate in virtual home visits (home visits conducted via video)?

Question: Is your program currently implementing any coaching strategies? Please describe them if so.

• Follow-up: How widespread is implementation of these strategies at your program?

  • Probe: implementation of strategies by all home visitors versus a subset

  • Probe: formality of strategies implemented - systematic implementation of explicit strategy by program, initially testing implementation of explicit strategy, implementing strategy more informally or on an ad hoc basis

• Follow-up: Can you briefly explain how these strategies came to be used by your home visitor staff? For example, were they suggested by program model developers as a result of the COVID-19 PHE, or proposed by program leadership, or did they emerge from informal discussion amongst staff?

Question: Are you aware of any documentation that your program has received from model developers, local or state organizations, or funding agencies related to coaching strategies? If so, would you be willing to share it with us if we agree to partner together?

• Follow-up: Has your program leadership or staff developed any formal or informal documentation about or guidance on your program’s use of these strategies? If so, would you be willing to share that with us if we agree to partner together?

Question: Tell me about how you expect the rate of virtual visits to change over [XX time period].

• Follow-up: What might influence changes in how often home visitors are providing virtual visits to families?

Part 4: Program Capacity and Interest

If we reach mutual agreement to partner with your program for the study, we will work with program-level leadership to jointly complete a study agreement that lays out roles and responsibilities. Agencies will receive a site payment of $1,500 for participation in the full study. I’d like to describe a few of the key components and get your feedback on whether the processes sound feasible for your program. In this conversation, I’d like to focus on some of the study processes that stand out to us as potential challenges to incorporate into your program’s workflow. However, we will also have a chance to discuss any questions that have come up for you based on the information sheet we provided that describes the study phases.

If we decide to partner with each other, we will work with your program leadership to formalize a staff and family recruitment plan. In total, the study will request participation from up to 3 program administrative staff (such as program directors, managers, and supervisors) and up to 10 home visitors. Six of these program staff (administrative and/or home visitors) will be asked to participate in focus groups at up to 6 timepoints. We will work with program leadership to develop a plan for selecting these administrative staff and home visitors.

We will also need assistance recruiting up to 6 family members served by your program’s home visitors to participate in 2 focus groups. The participating home visitors will be asked to complete a brief 10- to 15-minute online form weekly during learning cycles (each cycle is ~3 weeks) and to administer a 5-minute form with up to 12 family members (across all participating home visitors) at the end of visits conducted during learning cycles. As tokens of appreciation for participation in the study, we will provide caregivers who participate in focus groups with a payment of $40 for each family focus group

Question: Do you think the proposed process for the home visitor and family questionnaires would be feasible at your program?

• Probe: questions about this process

If we were to implement the study at your program, we would work with you to designate one program liaison who would help conduct recruitment activities as described above and as detailed in the recruitment plan formalized with program staff. This person would also help us coordinate focus groups with program staff and help with ongoing data collection.

Question: Do you think the proposed process would be feasible at your program?

• Probe: questions about this process

During the first phase of the study (the co-definition phase), we will work closely with program staff (i.e., program managers, supervisors, and home visitors) to understand the coaching strategies your program is using during virtual and in-person home visits. We will hold two focus groups in this phase. During the first focus group we will learn how, why, and when these strategies are used. During the second focus group, we will identify and define specific strategies that we will ask participating home visitors to implement during their visits in the study period.

Question: Do you think the proposed process would be feasible at your program?

• Probe: questions about this process

Question: Who at your program would need to sign off on the strategies selected for implementation during the focus group?

• Follow-up: Would it be possible for those individuals to attend the focus group to make it possible to have an approved set of strategies at the end of the focus group?

Over the course of the study, we will also recruit up to 12 family members receiving home visiting services from your program. Up to 6 of these family members would be recruited to participate in 1 or 2 focus groups, using flyers developed by the study team that outline the purpose and benefits of participation. Up to 12 will also be asked by participating home visitors to complete a brief form at the end of visits.

Question: Do you think the proposed process would be feasible at your program?

• Probe: questions about this process

Question: Based on what I’ve described of the study so far, does it seem like something your program would be interested in pursuing?

• Probe: questions or concerns about logistics described

• Probe: questions or concerns about anything detailed in the study information sheet not yet discussed

Part 5: Next Steps

Before we wrap up our conversation, I’d like to talk about a few possible next steps.

Question: Is there anyone else at your program who would need to review or approve partnering with us for the ADAPT-HV study?

• Follow-up: Who else at your program would want to review and/or sign a study agreement if we were to formalize a partnership?

• Follow-up: Does anyone else at your program need to review and approve recruitment materials for either program staff or families?

• Follow-up: Are there regulatory bodies like an Institutional Review Board that would need to review and approve of the study before implementing it at your organization?

• Follow-up: If yes, what does that process typically look like? How long does that process typically take?

As a reminder, if we decide to move forward with next steps after this call, we’d like to request any documentation you are aware of that your program has developed or received from model developers, local or state organizations, or funding agencies related to coaching strategies. We will use this information to get acquainted with the practices at your program before the initial focus group.

Part 6: Wrap-up

Thank you very much for your time today. I know I asked a lot of questions and probably raised some questions for you.

Question: What questions do you have? What concerns?

We are currently having conversations with other programs to assess their suitability for the study. We may have some further questions for you before deciding which programs will be recruited to participate. Could we reach out if there are additional questions?

Thank you again for your time! I will reach out with more information soon. Please let me know if you have any questions in the meantime.

If you have any questions about the study, please contact Teresa Smith at The Policy & Research Group ([email protected] or (225) 281-3783).

If you have questions about your rights as a research volunteer, you can call Health Media Lab Institutional Review Board at (202) 246-8504.

The Policy & Research Group 7