Our methods followed the structured Implementation Mapping process.
The CORE team leveraged previously conducted needs assessments relevant to the rural region. Data was identified and aggregated from existing county and/or regional health assessments as well as from a cancer needs assessment conducted by our academic NCI funded cancer institute, utilizing publicly available state level data, specifically for the regional cancer center. We included cancer incidence/mortality rates, cancer prevention metrics and modifiable risk factors to inform the development of a clinical trial assessment process.
In order to collect individual and organizational level ‘assessment’ data, the CORE team conducted 13 virtual video interviews with individuals who could offer perspectives from the county, community, hospital, clinic, provider, and patient level to an implementation strategy. Interviews took place over 5 months in 2020-21. To identify participants, we leveraged the Community Research Liaison who lived and worked in the area and utilized a snowball approach in our interviews to identify potential adopters, implementers, maintainers and other leaders who could best respond about regional assets and gaps.
The initial set of 52 (not inclusive of sub-questions) CFIR interview questions were collected utilizing the CFIR Guide Interview Guide tool; linking to the ‘Choose Interview Questions’(CFIR & Domains, 2009) site and were reduced to 25 based on expert review from the local Community Research Liaison and the CORE team lead. These questions focused on gaining participant perspectives on 1) the compatibility of their organization’s priorities with CPC research; 2) their organization’s openness to the implementation of CPC research based on organizational culture, internal champions and opinion leaders as well as outside pressures; and 3) needs of the community members served by their organization. All interviews were video or audio recorded and members of the research team (n = 3) took their own notes to capture quotes, ideas and perspectives of relevance to the project.
Interview recordings were transcribed and coded by the CORE team using the CFIR codebook and CFIR codebook spreadsheet documenting data analysis prompts, inclusive of detailed definitions about, inclusion and exclusion criteria for CFIR domains and descriptions of domain subitems.(CFIR & Templates, 2009) Emergent codes were identified within the broader categories pulled from CFIR, from interview notes and additional codes unique to the location and questions, such as “small town,” and “provider landscape” were added. The three CORE team members co-coded 1–2 of the transcripts in order to support the team’s collective understanding of the codes and assure intercoder reliability. We analyzed the data to the CFIR domains (Table 1) of inner setting, outer setting, individual characteristics,
Table 1
CFIR Constructs and Interview Question Categories
Inner Setting
(Community Organizations)
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Outer Setting
(Community/Region wide)
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Individual Characteristics
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Process Implementation
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Structural Characteristics
Goals and Feedback
Compatibility
Culture
Relative Priority
Implementation Climate
Tension for Change
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Cosmopolitanism
Peer Pressure
Patron Needs, Resources and Barriers
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Knowledge and Beliefs about the Intervention
Adopters and Implementers
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Engaging Opinion Leaders
Engaging Champions
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Table 2. Thematic Findings
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Inner Setting
(Community Organizations)
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Outer Setting
(Community/Region wide)
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Individual Characteristics
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Process Implementation
|
Adopters
Implementation Climate:
• Hard
• Easy
• Engagement Strategies
How to Engage, How Not to Engage with Participants, Engagement Considerations
• Resource Need Opportunities
• Resource Need Challenges
Maintenance and Sustainability
• Who/Entities
• How to Align CPC Research with Current Organizational Priorities
• Available Resources
Decision-Makers/Entities Conducting CPC-Related Work Currently
• Challenges
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Community wide:
• Fierce Independence
• Characteristics/Culture-Opportunities
• Characteristics/Culture-Challenges
• Resource Needs-Opportunities
• Resource Needs-Challenges
Provider Landscape:
• Recruitment and Retention
• Fierce Independence
• Opportunities
Small Town:
• Resource Need Challenges
|
People/Implementers for Different CPC Components
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NOTE: the research team determined there were no codes that fit this CFIR category since 1) we had conducted our needs assessment interviews at the community organization level, 2) these community organizations were not to be the ‘host’ of the research review process and 3) an implementation system had not yet been created.
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and process implementation. In addition to identifying assets and gaps that may support and hinder cancer prevention work in the region, we were also able to code for details such as “complexity of resource needs,” identify natural opportunities, locations or fit for cancer control clinical trial implementation and specific approaches to engaging in the community. The coded themes (Table 2) showed commonalities across regional challenges, opportunities, community-wide characteristics (community members and providers) as well as actionable guidance (e.g. engagement strategies, how to/not to engage with participants), organizational alignment with CPC work and community member needs but, ultimately, did not fully describe the community context which organizations operate within and how CPC research could be implemented, leading to a later step of creating a researcher reference tool, based on a non-CFIR framework, to better share a deeper community context (the Regional Cultural Landscape) with researchers.
Interviews were used to identify adopters and implementers in the region, some of whom were invited to participate in two community workgroups consisting of 4–6 participants each. The CORE team referenced Implementation Mapping tasks 1–5 to organize workgroup meetings and outcomes. Workgroups met virtually and a virtual whiteboard platform was used to create engagement and capture participant responses, feedback, and input. Both workgroup meetings had the same agenda items, activities to cover, and received a reminder email a week in advance. Each workgroup met four times separately and once as a larger group over the course of a month and a half. Between each meeting, the CORE team compiled workgroup ideas and feedback into action, documents, or frameworks in order to iteratively develop a research review process and relevant documents supporting the process. In each reminder email, we asked for participants to review documents and consider proposed processes.
During the first workgroup meeting we utilized Task 1 questions to guide community member activities and identify who the adopters, implementers and maintainers of the “intervention” (specifically, the process we were collaboratively developing to support CPC research) might be in their community. We specifically requested input about; Who will decide to adopt and use the process we develop? Which stakeholders will decision makers need to consult? Who will make resources available to implement the process we develop and CPC research? Who will implement the process we develop and CPC research? Will CPC research require different people to implement different components (and should those people be involved in the working group? And who will ensure that the process we develop continues as long as it is needed? We received input to all but the final question in the first workgroup meeting; circling back to the final question to begin the discussion at the second workgroup meeting.
Between the first and second workgroup meetings, the CORE team summarized the previous meeting outcomes and community member feedback to initiate draft performance objectives for implementing a research review process, inclusive of two (draft) forms.
The CORE team organized the needs assessment data with a lens toward immediately actionable items and input. During the second workgroup meeting, we introduced a mini strategic Strengths, Weaknesses, Opportunities, Threats/Challenges (SWOT) analysis as a method for organizing researcher requests as strengths and weaknesses against the opportunities and challenges in the region that we had identified from thematic analysis.(Gürel & E, 2017) We also introduced, conceptually, the use of a PESTLE Analysis as a framework to organize the broad, in-depth needs assessment that we had been iteratively collecting throughout this project.(PESTLE & ANALYSIS, 2011) We will discuss the use of PESTLE in relation to Implementation Mapping Task 3 as a step included in the implementation strategy. The goal of the SWOT process was to identify a potential approach and scoring mechanism for how well incoming research requests could match, leverage the assets and fill in gaps of the region, per the multi-level needs assessment, and which would lead to successful or feasible implementation of CPC research. Based on the prompts of a SWOT scoring matrix, the CORE team developed a draft “Researcher Request to the Community” form and “Regional Capacity Response” form.
The Researcher Request to Community form was adapted from an existing site assessment questionnaire developed to assess rural cancer center’s ability to conduct clinical trials. We retained open and closed ended questions about assets and gaps a clinical trial might be able to fill (e.g., strengths and weaknesses of our mini-SWOT analysis), and included questions specific to how a proposed trial could acknowledge and be consciously responsive to stated needs about the community of interest (e.g., opportunities and challenges of our mini-SWOT analysis). The Regional Capacity Response form was adapted from existing clinical trial feasibility assessments also currently in use by our cancer institute. The purpose of this form is to assess fit between an incoming research request and the region’s ability to support the specific project request. These draft forms were shared prior to and reviewed during the second workgroup meeting for input to the question; “What has to change in order to bring about the performance objective (implementation of CPC research in the region)?” Workgroup members reviewed the draft forms in the context of their own lived experiences, knowledge about regional resources, needs assessment data and contributed ideas in the online white board space. Edits requested by the workgroups to both forms were incorporated by the CORE team between meetings 2 and 3.
“Using Task 3 in Implementation Mapping allows the planner to make decisions about strategy selection or development that logically follow the previous Implementation Mapping steps. (Kok et al., 2016; Koutoukidis et al., 2018) …Additionally, it is very important that the methods are translated into a practical strategy in a way that preserves the parameters for effectiveness and fits with the target population, culture, and context.” (Kok et al., 2016) Between the second and third meetings, the CORE team organized all needs assessment data into a standardized format that included information about the political, economic, social, technological, legal and environmental characteristics of the region, adding a ‘C’ to represent ‘cancer’ (C-PESTLE).
During the third workgroup meetings, the CORE team presented the organized needs assessment data (cancer rates, cancer prevention metrics, modifiable risk factors and thematic analysis results) into a densely populated C-PESTLE slide deck. The C-PESTLE informed discussion around two specific questions: 1) what information about the community, patient population, and region (e.g. the cultural context within which partnering community organizations work) would be useful for researchers to understand and respond to prior to initiating a study, and 2) what resources, assets and processes are necessary for clinicians, the hospital, other clinical settings, CPC-aligned community-based organizations and community members to consider in assessing the feasible implementation and collaborative initiation of a regionally-conducted research study. To address question 1, each workgroup reviewed the C-PESTLE, contributed additional contextual perspectives, requested additions and refinements and also proposed developing a more easy-to-digest summary of the region for researchers to reference; the Regional Cultural Landscape. To address question 2, the workgroups reviewed the revised Regional Capacity Response form to assure it addressed the areas identified as needs in the initial assessment, adding 13 prompts in three different sections (Population of Interest [n = 2], Project Plan/Protocol [n = 2], Budget and/or Resource Needs [n = 9]). As a reminder, the Regional Capacity Response form is meant to align the research project (the Strengths and Weaknesses potentially impacting a region) against Opportunities & Threats/Challenges relevant to and identified in the region (per mini-SWOT and all collected data). This form therefore includes prompts the community requires for deciding whether a project can be run successfully or not. The CORE team finalized forms before the next workgroup meeting.