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Table 2 Study Protocol and Cancer Prevention CDS Changes Made by CFIR Outer Setting and Inner Setting Domains and Constructs [26]

From: Pre-implementation adaptation of primary care cancer prevention clinical decision support in a predominantly rural healthcare system

CFIR Domains & Related ConstructsChange NumberElements of the Initial ProtocolBarriers
New Protocol (Change Made)Source of Barriers or Facilitators Encountered
 D. External Policy & IncentivesA broad construct that includes external strategies to spread interventions, including policy and regulations (governmental or other central entity), external mandates, recommendations and guidelines, pay-for-performance, collaboratives, and public or benchmark reporting.
 7Biannual mammography for women of average breast cancer risk ages 50 to 74 based on USPSTF guidelines [34]. Also providing BCRAT scores for women ages 50 to 74.Healthcare system encouraging annual mammography starting at age 40 for all women, which does not align with USPSTF guidelines [34] followed in the cancer prevention CDS. Offer biannual mammography for women of average breast cancer risk ages 50 to 74 based on USPSTF guidelines [34].
Recommend discussion with PCP for women at higher than average risk ages 35 to 49 due to the BCRAT calculating scores from ages 35 and up [29, 30].
Pre-implementation engagement (primary care leaders).
 8Targeted secondary cancer screenings: breast, cervical, and colorectal cancers. Healthcare system leadership asked for lung cancer screening to be included to encompass all four USPSTF recommended screenings [33,34,35,36].
Healthcare system offered lung cancer screening.
Added lung cancer screening to the cancer prevention CDS.Pre-implementation engagement (Healthcare system primary care and other leaders).
 B. Networks & CommunicationsThe nature and quality of webs of social networks and the nature and quality of formal and informal communications within an organization.
 9Conduct PCP and medical assistant focus groups.Healthcare system study clinics span three upper Midwestern states in predominately rural areas.Healthcare system has virtual networking capabilities and tools.Conduct PCP and medical assistant interviews, including using the healthcare system’s virtual networking tools.Pre-implementation engagement (Healthcare system primary care leaders).
 10Clinic trainings, later replaced by e-learning disseminated to intervention clinic leaders, PCPs, and medical assistants.Uneven uptake of the previous cardiovascular CDS system's e-learning.Recommendations for multiple learning points and training types.Multi-modal training plan including e-learning, webinars recorded and uploaded to intranet, and in-person/virtual trainings with clinics over a 6-month post-implementation window.Key informant interviews.
 11Surveying intervention and control clinic patients through the healthcare system's patient portal.All patient surveys must first go through the healthcare system’s marketing department.
Patient surveys cannot be targeted to specific clinics through the patient portal.
Institution developing the cancer prevention CDS has a Survey Research Center.Using the Survey Research Center to survey study patients either through: written mailed or telephone surveys.Pre-implementation engagement (Healthcare system marketing and patient portal departments).
 D. Implementation ClimateThe absorptive capacity for change, shared receptivity of involved individuals to an intervention, and the extent to which use of that intervention will be rewarded, supported, and expected within their organization.
  2. CompatibilityThe degree of tangible fit between meaning and values attached to the intervention by involved individuals, how those align with individuals’ own norms, values, and perceived risks and needs, and how the intervention fits with existing workflows and systems.
 12One intervention arm to have trained medical assistants give eligible patients scripted cancer prevention CDS recommendations and information, as well as initiate orders, prior to PCPs entering the room.Medical assistants cannot initiate all necessary orders for PCPS in the healthcare system EHR.
Medical assistants do not have similar roles in the cardiovascular CDS system studies.
Decision to have only one integrated CDS system with both cancer prevention and cardiovascular risk reduction goals.
Healthcare system interest in shared decision-making and SDMT.
Medical assistants already asked to print and distribute cardiovascular CDS materials for patients and PCPs.
Replaced medical assistant arm with an intervention arm that receives both the cancer prevention CDS and five SDMT.
Medical assistants, and other rooming staff, are still trained to provide patient cancer prevention CDS materials to patients prior to PCPs entering the room and give PCPs’ print outs to PCPs in both intervention arms.
Pre-implementation engagement (Healthcare system primary care leaders, gastroenterology shared decision-making group, breast cancer shared decision-making group, technology learning and support staff, and cardiovascular CDS study staff).
 4Cancer prevention CDS trigger for body mass index alone.Pilot testing showed frequent triggering of the cancer prevention CDS based on body mass index alone.Healthcare system-level goal to address body mass index. Body mass index also triggers the cardiovascular CDS.The cancer prevention CDS only triggers for body mass index if at least one other primary or secondary cancer area is also triggered.Pre-implementation engagement (Healthcare system primary care leaders).
Pilot testing.
 6Cancer prevention CDS PCP goal-setting function and patient follow-up and monitoring plan.Inconsistent patient follow-up and monitoring infrastructure across the healthcare system’s three markets.Healthcare system has own system of best practice advisories and screening and prevention recommendations within the EHR.Eliminated CDS PCP goal-setting function and patient follow-up and monitoring plan.Pre-implementation engagement (Healthcare system staff managing patient communication).
 E. Readiness for ImplementationTangible and immediate indicators of organizational commitment to its decision to implement an intervention.
  1. Leadership EngagementCommitment, involvement, and accountability of leaders and managers with the implementation.
 3Risk calculators for breast [29, 30] and colorectal cancers [31]. Healthcare system offered lung cancer screening.
Healthcare system leadership asked for a lung cancer risk calculator to be included.
Added a lung cancer risk calculator [32].Pre-implementation engagement (Healthcare system primary care and other leaders).
  2. Available ResourcesThe level of resources dedicated for implementation and on-going operations, including money, training, education, physical space, and time.
 1330 clinic randomization scheme.The cardiovascular CDS system studies already included the largest healthcare system clinics.36 clinic randomization scheme (with three clinics randomized together) for the cardiovascular CDS system studies.Same 36 clinic randomization scheme (with three clinics randomized together) as the cardiovascular CDS system studies.Pre-implementation engagement (Healthcare system primary care leaders and cardiovascular CDS study team).
 14Offer flexible sigmoidoscopy and fecal occult blood tests for colorectal cancer screening.The healthcare system no longer offers flexible sigmoidoscopy or fecal occult blood tests.The healthcare system offers FIT (also referred to as IFOB) and FIT Cologuard® DNA tests, as well as colonoscopy.Removed flexible sigmoidoscopy and fecal occult blood tests as options for the cancer prevention CDS. Included FIT/IFOB and FIT DNA (Cologuard®) options.Pre-implementation engagement (Healthcare system primary care leaders, gastroenterology department members, and EHR programmers).
  1. Note. Only CFIR [26] domains and constructs relevant to study changes are included here. Complete key informant interview results are reported elsewhere [15]. CDS, clinical decision support; D&I, dissemination and implementation; EHR, electronic health record; FIT/FIT DNA, fecal immunochemical test deoxyribonucleic acid; IFOB, immunoassay fecal occult blood test; PCP, primary care provider; SDMT, shared decision-making tool; USPSTF, U.S. Preventative Services Task Force