Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol

Abstract

Background Screening for colorectal cancer (CRC) not only detects disease early when treatment is more effective but also prevents cancer by finding and removing precancerous polyps. Because many of our nation’s most disadvantaged and vulnerable individuals obtain health care at federally qualified health centers, these centers play a significant role in increasing CRC screening among the most vulnerable populations. Furthermore, the full benefits of cancer screenings must include timely and appropriate follow-up of abnormal results. Thus, the purpose of this study is to implement a multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care in federally qualified health centers, as well as simultaneously to observe and to gather information on the implementation process to improve the adoption, implementation, and sustainment of the intervention. The multilevel intervention will target three different levels of influences: organization, provider, and individual. It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation. Methods This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four clusters of clinics from four different FQHC systems. In the first phase, there will be a 3-month waiting period during which no intervention components will be implemented. After the 3-month waiting period, we will randomize two clusters to cross from the control to the intervention and the remaining two clusters to follow 3 months later. All clusters will stay at the same phase for 9 months, followed by a 3-month transition period, and then cross over to the next phase. Discussion There is a pressing need to reduce disparities in CRC outcomes, especially among racial/ethnic minority populations and among populations who live in poverty. Single-level interventions are often insufficient to lead to sustainable changes. Multilevel interventions, which target two or more levels of changes, are needed to address multilevel contextual influences simultaneously. Multilevel interventions with multiple components will affect not only the desired outcomes but also each other. How to take advantage of multilevel interventions and how to implement such interventions and evaluate their effectiveness are the ultimate goals of this study. Trial registration This protocol is registered at clinicaltrials.gov (NCT04514341) on 14 August 2020.

Factors That Support Sustainability of Health Systems Change to Increase Colorectal Cancer Screening in Primary Care Clinics: A Longitudinal Qualitative Study

“…Providing funding to partner clinics can facilitate program start-up and implementation. Our results suggest adequate funding can facilitate strong EBI and SA implementation, particularly in FQHCs providing comprehensive primary care to medically underserved communities and vulnerable populations that may be financially strained (Kim et al, 2020). However, this study emphasized the need for funding amounts to be “just right”– enough to support successful expansion and replication of EBIs and SAs without creating financial dependency on CRCCP awardees.…”

Interventions for cancer screening among Chinese Americans: A systematic review and meta-analysis

“…Fourth, single component interventions are often insufficient to lead to sustainable change. On the contrary, multiple-component interventions not only affect the desired outcomes but also multiple associated outcomes [ 51 ]. It is necessary to have multiple components to address multi-level influences simultaneously, since multiple strategies are generally more effective than a single strategy for increasing cancer screening [ 52 ].…”

Evaluating Uptake of Evidence-Based Interventions in 355 Clinics Partnering With the Colorectal Cancer Control Program, 2015–2018

“…Furthermore, many clinics could not provide data on the racial and ethnic characteristics of patients, and we were not able to examine if those characteristics were related to the uptake of intervention strategies, particularly patient navigation. Future studies should assess theoretical constructs that are relevant for implementation to illuminate the determinants of implementation and sustainability ( 38 ). We also did not have information about the quality of EBI and SA implementation, which likely varies considerably across clinics.…”