This clinical trial studies how best to implement a colorectal cancer (CRC) screening intervention at primary care clinics. Primary care clinics deliver healthcare to 90 percent of adults in the United States. The primary responsibility for introducing CRC risk to patients and referring for screening resides with primary care clinics providing preventive care to their patients. While primary care clinic patients who receive recommendations to screen from their clinicians are much more likely to complete screening, such recommendations are significantly less likely to be given to those with limited English proficiency. For CRC, language differences between healthcare providers and patients negatively impacts the likelihood of screening. Determining how a CRC screening tool can best be implemented for which patients and under which circumstances is crucial to future CRC screening research and clinical improvement efforts. In this trial, the implementation strategy combines Normalization Process Theory (NPT) with “participatory learning in action” (PLA), a participatory health research method that emphasizes the development of meaningful partnerships based on the core values of co-creation, providing mutual benefit, trust, active participation, and shared decision-making from project start to finish, as well as the resilience, capabilities and agency of people from these groups. NPT is a framework originally developed to describe the implementation of complex primary care practice-based interventions, with an emphasis on patient-clinician communication and promotion of culturally-sensitive practices. This trial may help researchers determine if using NPT and PLA together works as well as usual methods to implement a CRC screening intervention at multiple primary care clinics.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06682650.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer CenterStatus: Active
Contact: Joseph LeMaster
Phone: 913-574-0483
PRIMARY OBJECTIVES:
I. To test whether a Normalization Process Theory-guided Participatory Learning in Action (NPT-PLA) guided implementation of a proven Implementation Intentions (I^2) based colorectal cancer screening tool versus usual quality improvement (control) implementation in primary care practices using a cluster randomized trial improves screening uptake (i.e. screening completion) within 6 months of enrollment.
II. To evaluate, using qualitative methods, the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework.
OUTLINE: Participating clinics are randomized to 1 of 2 arms. Participants receive study interventions according to which arm their clinic is randomized to.
ARM I (NPT-PLA): Clinic staff and patients participate in "implementation teams” (i-teams) on study. I-team participants produce a workflow map at baseline describing how they currently conduct CRC screening and complete the NOMAD survey. I-team participants are then provided a pre-specified protocol that follows an approach to implementing I^2 and are asked to integrate into their clinic workflow using NOMAD survey-based assessment of their clinic’s capacity for implementation. Thereafter, i-team participants meet monthly and use PLA methods to adapt the protocol and implement I^2 to their clinical context.
ARM II (QUALITY IMPROVEMENT [QI]): Clinic staff and patients participate in i-teams on study. I-team participants produce a workflow map at baseline describing how they currently conduct CRC screening and complete the NOMAD survey. I-team participants are then provided a pre-specified protocol that follows an approach to implementing I^2. Thereafter, i-team participants meet monthly and use their usual QI methods to adapt the protocol and implement I^2 to their clinical context.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorJoseph LeMaster
