scholarly journals 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

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Karen Kim ◽  
Blasé Polite ◽  
Donald Hedeker ◽  
David Liebovitz ◽  
Fornessa Randal ◽  
...  

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.

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Teri L. Malo ◽  
Sara Y. Correa ◽  
Alexis A. Moore ◽  
Renée M. Ferrari ◽  
Jennifer Leeman ◽  
...  

Abstract Background Although colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial. Methods We will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants. Discussion This hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations. Trial registration The trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).


2021 ◽  
Author(s):  
Teri L. Malo ◽  
Sara Y. Correa ◽  
Alexis A. Moore ◽  
Renée M. Ferrari ◽  
Jennifer Leeman ◽  
...  

Abstract BackgroundAlthough colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial.MethodsWe will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4,000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants.DiscussionThis hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations.Trial registrationThe trial was registered on May 28, 2020 at ClinicalTrials.gov (identifier NCT04406714).


2020 ◽  
Vol 21 (6) ◽  
pp. 891-897
Author(s):  
Mary Ellen Conn ◽  
Stephenie Kennedy-Rea ◽  
Sujha Subramanian ◽  
Adam Baus ◽  
Sonja Hoover ◽  
...  

The purpose of this study is to evaluate the effectiveness of the West Virginia Program to Increase Colorectal Cancer Screening in implementing patient reminders to increase fecal immunochemical test (FIT) kit return rates in nine federally qualified health centers (FQHCs). Using process measures and cost data collected, the authors examined the differences in the intensity of the phone calls across FQHCs and compared them with the return rates achieved. They also reported the cost per kit successfully returned as a result of the intervention. Across all FQHCs, 5,041 FIT kits were ordered, and the initial return rate (without a reminder) was 41.1%. A total of 2,201 patients received reminder phone calls; on average, patients received 1.61 reminder calls each. The reminder interventions increased the average FIT kit return rate to 60.7%. The average total cost per FIT kit returned across all FQHCs was $60.18, and the average cost of only the reminders was $11.20 per FIT kit returned. FQHCs achieved an average increase of 19.6 percentage points in FIT kit return rates, and costs across clinics varied. Clinics with high-quality health information systems that enabled tracking of patients with minimal effort were able to implement lower cost reminder interventions.


2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Aaron J. Kruse-Diehr ◽  
Jill M. Oliveri ◽  
Robin C. Vanderpool ◽  
Mira L. Katz ◽  
Paul L. Reiter ◽  
...  

Abstract Background Colorectal cancer (CRC) screening rates are lower in Appalachian regions of the United States than in non-Appalachian regions. Given the availability of various screening modalities, there is critical need for culturally relevant interventions addressing multiple socioecological levels to reduce the regional CRC burden. In this report, we describe the development and baseline findings from year 1 of “Accelerating Colorectal Cancer Screening through Implementation Science (ACCSIS) in Appalachia,” a 5-year, National Cancer Institute Cancer MoonshotSM-funded multilevel intervention (MLI) project to increase screening in Appalachian Kentucky and Ohio primary care clinics. Methods Project development was theory-driven and included the establishment of both an external Scientific Advisory Board and a Community Advisory Board to provide guidance in conducting formative activities in two Appalachian counties: one in Kentucky and one in Ohio. Activities included identifying and describing the study communities and primary care clinics, selecting appropriate evidence-based interventions (EBIs), and conducting a pilot test of MLI strategies addressing patient, provider, clinic, and community needs. Results Key informant interviews identified multiple barriers to CRC screening, including fear of screening, test results, and financial concerns (patient level); lack of time and competing priorities (provider level); lack of reminder or tracking systems and staff burden (clinic level); and cultural issues, societal norms, and transportation (community level). With this information, investigators then offered clinics a menu of EBIs and strategies to address barriers at each level. Clinics selected individually tailored MLIs, including improvement of patient education materials, provision of provider education (resulting in increased knowledge, p = .003), enhancement of electronic health record (EHR) systems and development of clinic screening protocols, and implementation of community CRC awareness events, all of which promoted stool-based screening (i.e., FIT or FIT-DNA). Variability among clinics, including differences in EHR systems, was the most salient barrier to EBI implementation, particularly in terms of tracking follow-up of positive screening results, whereas the development of clinic-wide screening protocols was found to promote fidelity to EBI components. Conclusions Lessons learned from year 1 included increased recognition of variability among the clinics and how they function, appreciation for clinic staff and provider workload, and development of strategies to utilize EHR systems. These findings necessitated a modification of study design for subsequent years. Trial registration Trial NCT04427527 is registered at https://clinicaltrials.gov and was registered on June 11, 2020.


2014 ◽  
Vol 42 (1) ◽  
pp. 26-31 ◽  
Author(s):  
Gloria D. Coronado ◽  
Amanda F. Petrik ◽  
Mark Spofford ◽  
Jocelyn Talbot ◽  
Huyen Hoai Do ◽  
...  

Author(s):  
Jessica Law ◽  
Jeannine Viczko ◽  
Robert Hilsden ◽  
Emily McKenzie ◽  
Mark Watt ◽  
...  

IntroductionColorectal cancer (CRC) screening is associated with significant reductions in burden, mortality and cost. Primary care providers in Alberta do not have access to integrated CRC testing histories for patients. Providing this information will support CRC screening among patients at average and high risk, follow-up of abnormal tests, and surveillance. Objectives and ApproachCalgary Laboratory Services, Colon Cancer Screening Centre, Alberta Cancer Registry, and endoscopy data were linked to create a comprehensive CRC screening history at the patient level. Based on screening histories and the current Clinical Practice Guideline, an algorithm was created to determine CRC screening statuses with the aim of providing accurate screening rates when linked to primary care provider patient panels. Results from the linkage are designed to be incorporated into clinic and EMR workflow processes to support adherence to evidence-based screening recommendations at the point of care. ResultsA comprehensive assessment of screening status was determined by integrating Fecal Immunochemical Test (FIT) and colonoscopy data. Among a sample cohort, patients were identified as being due for screening with FIT, requiring follow-up for a positive FIT test, or requiring appropriate surveillance for a positive-screen or abnormal colonoscopy findings. A summary report, actionable list, and resources were developed to convey findings. The summary report displayed CRC screening rates for a provider’s panel. The actionable list provided CRC screening statuses for each patient aged 40 to 84 indicating patients due for screening with FIT, for follow-up of positive FIT, or for surveillance colonoscopy. The resources were developed to support quality improvement for colorectal cancer screening for patients. Conclusion/ImplicationsThe data linkages and algorithm provide comprehensive CRC screening, follow-up, and surveillance information that could support guideline-adherent screening, increase screening rates, reduce duplication or unnecessary testing, and provide primary care providers with timely and robust information to support clinical decisions for individuals inside and outside of the target screening population.


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