Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool ("I2") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the "I2" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the "when," "where" and "how" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participation (2000 in total). All patients eligible for CRC screening will be offered the I2 tool. Their choices will be communicated automatically to clinics for order entry. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff); completion of the I2 tool and CRC screening completion (by patients) over 6 months of patient follow-up. For Aim 2, surveys based on the NPT domains (the "NOMAD") will be used to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential impact of using the tool in their setting. Investigators will conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in "real-world" primary care clinical settings.
None
patients ineligible for routine screening based on a personal or close family history of colorectal cancer or who have increased genetic risk of colon cancer.
cognitive or decisional incapacity will be excluded from the implementation teams, after completion of a brief, validate screening tool, the Mini-Cog Exam.
Parallel
NPT-PLA
BehavioralNPT-PLA was developed and initially tested in 5 European countries in the EU-funded RESTORE study. PLA "Participatory Learning in Action" is a set of participatory research techniques in which participants use democratic processes to identify key actions needed to achieve a specific goal e.g. implementation of a tested decision making tool such as I2; and prioritize which of these need to be acted upon first and subsequently (in which order). Normalization Process Theory (NPT) is combined with PLA to help implementation teams using PLA to assess organization capacity and readiness to enact the selected action steps vis-a-vis NPT constructs, iteratively. These are coherence "does everyone understand what needs to be done?"; Cognitive participation "Does everyone who needs to act 'buy in' to take action"; collective action "Is everyone who needs to act taking steps to make the change?'; and reflexive monitoring "After the step has been taken, has it had the desired impact on the goal?"
Usual Quality Improvement
BehavioralUsual quality improvement includes principles of continuous quality improvement, such as Plan-Do-Study-Act cycles, to implement a specific goal. In this study, 'usual QI' methods already in use in 'active comparator' arm will be documented during the baseline assessment of clinical workflows in clinics assigned to that arm; and will be provided with a 'preset protocol' to implement the study shared decision-making tool (I2). Processes that implementation teams in these clinics use to achieve implementation will be documented.
Aim 1: Completion of CRC screening orders
Extracted from patient participant electronic medical records by DARTNet staff, this will be an indicator variable (0= not completed, 1= completed) indicating if the event occurred within 6 months of the date that the patient was first presented the I2 tool
Aim 1: Completion of recommended CRC screening
Extracted from patient participant electronic medical records by DARTNet staff, this will be an indicator variable (0= not completed, 1= completed) indicating if the event occurred within 6 months of the date that the patient was first presented the I2 tool
Aim 2: Summative focus group discussion qualitative data
We have chosen focus group discussions to collect qualitative data in which I-team members will synergistically identify and clarify their views about implementation intervention, as would not take place in individual interviews. The purpose of the focus group discussions is to (1) review the TIDieR survey responses to clear up any questions about treatment fidelity (2), review the workflow maps they made in the initial session and discuss how workflow has changed; and (3) explore levers and barriers to work flow changes to implement I2. These focus group discussions will focus on levers and barriers to implementing I2 using the approach that each clinic has used (NPT-PLA or usual QI) using the 2022 NPT framework that accounts for context. We will audiorecord and transcribe and deidentify focus group interview data for qualitative thematic analysis.
Aim 1: Completion of the I2 shared-decision making tool
Extracted from a DARTNet-hosted Redcap database into which enrolled I2 results will be recorded, data for this study will be an indicator variable (0= not completed, 1=completed, 2= fully completed) indicating if the event occurred within 6 months after the date that the patient was first presented the I2 tool.
Aim 2: NOMAD Survey
The NOMAD is a validated survey that includes 23 Likert-style statements (range 0-10) indicating agreement to the statement) corresponding to statements regarding each of the 4 mechanism constructs of the Normalization Process Theory implementation framework. Individual members of the implementation teams in clinics in the NPT-PLA arm of the study will respond to NOMAD to assess the capacity of their clinic to implement the I2 tool and carry out the intervention to which their clinic has been randomized.
Aim 2: Qualitative meeting notes
NPT-PLA intervention and usual QI control groups will provide reports of their implementation meetings. In NPT-PLA groups this will include a report of of NPT-informed PLA sessions. NPT-PLA Team Leads from each clinic will also DARTNet/AAFP NRN study staff in monthly 'checkin' meetings, during which a staff report will be made . Similar 'checkin' meetings will occur between usual QI control clinic Team leads and a separate study staff member. These minutes will be analyzed with TIDieR checklist data to analyze implementation team fidelity to the assigned arm intervention activities.
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University of Kansas Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
DARTNet Institute
Collaborator
