The Plan-Do-Study-Act (PDSA) cycle is a commonly used improvement process in health care settings, although its documented use in pragmatic clinical research is rare. A recent pragmatic clinical research study, called the Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), used this process to optimize the research implementation of an automated colon cancer screening outreach program in intervention clinics. We describe the process of using this PDSA approach, the selection of PDSA topics by clinic leaders, and project leaders’ reactions to using PDSA in pragmatic research. STOP CRC is a cluster-randomized pragmatic study that aims to test the effectiveness of a direct-mail fecal immunochemical testing (FIT) program involving eight Federally Qualified Health Centers in Oregon and California. We and a practice improvement specialist trained in the PDSA process delivered structured presentations to leaders of these centers; the presentations addressed how to apply the PDSA process to improve implementation of a mailed outreach program offering colorectal cancer screening through FIT tests. Center leaders submitted PDSA plans and delivered reports via webinar at quarterly meetings of the project’s advisory board. Project staff conducted one-on-one, 45-min interviews with project leads from each health center to assess the reaction to and value of the PDSA process in supporting the implementation of STOP CRC. Clinic-selected PDSA activities included refining the intervention staffing model, improving outreach materials, and changing workflow steps. Common benefits of using PDSA cycles in pragmatic research were that it provided a structure for staff to focus on improving the program and it allowed staff to test the change they wanted to see. A commonly reported challenge was measuring the success of the PDSA process with the available electronic medical record tools. Understanding how the PDSA process can be applied to pragmatic trials and the reaction of clinic staff to their use may help clinics integrate evidence-based interventions into their everyday care processes. Clinicaltrials.gov NCT01742065 . Registered October 31, 2013.

Background: Mailed fecal immunochemical testing (FIT) programs can improve colorectal cancer (CRC) screening rates, but health systems vary how they implement (i.e., adapt) these programs for their organizations. A health insurance plan implemented a mailed FIT program (named BeneFIT), and participating health systems could adapt the program. This multi-method study explored which program adaptations might have resulted in higher screening rates.Methods: First, we conducted a descriptive analysis of CRC screening rates by key health system characteristics and program adaptations. Second, we generated an overall model by fitting a weighted regression line to our data. Third, we applied Configurational Comparative Methods (CCMs) to determine how combinations of conditions were linked to higher screening rates. The main outcome measure was CRC screening rates.Results: Seventeen health systems took part in at least 1 year of BeneFIT. The overall screening completion rate was 20% (4–28%) in year 1 and 25% (12–35%) in year 2 of the program. Health systems that used two or more adaptations had higher screening rates, and no single adaptation clearly led to higher screening rates. In year 1, small systems, with just one clinic, that used phone reminders (n= 2) met the implementation success threshold (≥ 19% screening rate) while systems with > 1 clinic were successful when offering a patient incentive (n= 4), scrubbing mailing lists (n= 4), or allowing mailed FIT returns with no other adaptations (n= 1). In year 2, larger systems with 2–4 clinics were successful with a phone reminder (n= 4) or a patient incentive (n= 3). Of the 10 systems that implemented BeneFIT in both years, seven improved their CRC screening rates in year 2.Conclusions: Health systems can choose among many adaptations and successfully implement a health plan’s mailed FIT program. Different combinations of adaptations led to success with health system size emerging as an important contextual factor.

Background: Colorectal cancer screening uptake is low, particularly among individuals enrolled in Medicaid. To the authors' knowledge, little is known regarding the effectiveness of direct‐to‐member outreach by Medicaid health insurance plans to raise colorectal cancer screening use, nor how best to deliver such outreach.Methods: BeneFIT is a hybrid implementation‐effectiveness study of 2 program models that health plans developed for a mailed fecal immunochemical test (FIT) intervention. The programs differed with regard to whether they used a centralized approach (Health Plan Washington) or collaborated with health centers (Health Plan Oregon). The primary implementation outcome of the current study was the percentage of eligible enrollees to whom the plans delivered each intervention component. The primary effectiveness outcome was the rate of FIT completion within 6 months of mailing of the introductory letter.Results: The health plans identified 12,000 eligible enrollees (8551 in Health Plan Washington and 3449 in Health Plan Oregon). Health Plan Washington mailed an introductory letter and FIT kit to 8551 enrollees (100%) and delivered a reminder call to 839 (10.3% of the 8132 attempted). Health Plan Oregon mailed an introductory letter, and a letter and FIT kit plus a reminder postcard to 2812 enrollees (81.5%) and 2650 enrollees (76.8%), respectively. FIT completion rates were 18.2% (1557 of 8551 enrollees) in Health Plan Washington. In Health Plan Oregon, completion rates were 17.4% (488 of 2812 enrollees) among enrollees who were mailed an introductory letter and 18.3% (484 of 2650 enrollees) among enrollees who also were mailed a FIT kit plus reminder postcard.Conclusions: The implementation of mailed FIT outreach by health plans may be effective and could reach many individuals at risk of developing colorectal cancer.

Screening rates for colorectal cancer (CRC) remain low, especially among certain populations. Mailed fecal immunochemical testing (FIT) outreach initiated by U.S. health plans could reach underserved individuals, while solving CRC screening data and implementation challenges faced by health clinics. We report the models and motivations of two health insurance plans implementing a mailed FIT program for age-eligible U.S. Medicaid and Medicare populations. One health plan operates in a single state with ~220,000 enrollees; the other operates in multiple states with ~2 million enrollees. We conducted in-depth qualitative interviews with key stakeholders and observed leadership and clinic staff planning during program development and implementation. Interviews were transcribed and coded using a content analysis approach; coded interview reports and meeting minutes were iteratively reviewed and summarized for themes. Between June and September 2016, nine participants were identified, and all agreed to the interview. Interviews revealed that organizational context was important to both organizations and helped shape program design. Both organizations were hoping this program would address barriers to their prior CRC screening improvement efforts and saw CRC screening as a priority. Despite similar motivations to participate in a mailed FIT intervention, contextual features of the health plans led them to develop distinct implementation models: a collaborative model using some health clinic staffing versus a centralized model operationalizing outreach primarily at the health plan. Data are not yet available on the models’ effectiveness. Our findings might help inform the design of programs to deliver mailed FIT outreach.

Background: Colorectal cancer (CRC) screening can improve health outcomes, but screening rates remain low across the US. Mailed fecal immunochemical tests (FIT) are an effective way to increase CRC screening rates, but is still underutilized. In particular, cost of FIT has not been explored in relation to practice characteristics, FIT selection, and screening outreach approaches. Methods: We administered a cross-sectional survey drawing from prior validated measures to 252 primary care practices to assess characteristics and context that could affect the implementation of direct mail fecal testing programs, including the cost, source of test, and types of FIT used. We analyzed the range of costs for the tests, and identified practice and test procurement factors. We examined the distributions of practice characteristics for FIT use and costs answers using the non-parametric Wilcoxon rank-sum test. We used Pearson’s chi-squared test of association and interpreted a low p-value (e.g. < 0.05) as evidence of association between a given practice characteristic and knowing the cost of FIT or fecal occult blood test (FOBT). Results: Among the 84 viable practice survey responses, more than 10 different types of FIT/FOBTs were in use; 76% of practices used one of the five most common FIT types. Only 40 practices (48%) provided information on FIT costs. Thirteen (32%) of these practices received the tests for free while 27 (68%) paid for their tests; median reported cost of a FIT was $3.04, with a range from $0.83 to $6.41 per test. Costs were not statistically significantly different by FIT type. However, practices who received FITs from manufacturer’s vendors were more likely to know the cost (p = 0.0002) and, if known, report a higher cost (p = 0.0002). Conclusions: Our findings indicate that most practices without lab or health system supplied FITs are spending more to procure tests. Cost of FIT may impact the willingness of practices to distribute FITs through population outreach strategies, such as mailed FIT. Differences in the ability to obtain FIT tests in a cost-effective manner could have consequences for implementation of outreach programs that address colorectal cancer screening disparities in primary care practices.

Implementation of screening brief intervention and referral to treatment (SBIRT) and medication-assisted treatment for alcohol use disorder (MAUD) remains low in primary care. ANTECEDENT (Partnerships to Enhance Alcohol Screening, Treatment, and Intervention) was a practice-facilitator led implementation study to increase SBIRT and MAUD use in diverse primary care clinics. From November 2019 – April 2023, we conducted a convergent parallel mixed methods evaluation. Participants were small and medium-sized primary care clinics in the Northwestern U.S. Clinics received foundational support (i.e., baseline/exit assessment, access to SBIRT Oregon website) and the option for supplemental implementation support (e.g., practice facilitation, expert consultation) over the 15-month intervention to improve SBIRT and MAUD. Qualitative and quantitative data regarding clinic characteristics, implementation strategies, and SBIRT/MAUD outcomes were collected through practice facilitator interviews, periodic reflections and clinic contact logs, interviews, pre-post surveys, and electronic health record (EHR) queries. Quantitative analyses included descriptive statistics, logistic regression, and the Wilcoxon sign-ranked test. Qualitative analysis took an immersion crystallization approach. Data were reviewed in a matrix to evaluate intervention adoption, implementation, and effectiveness. We recruited 75 unique clinics; 66 participated and 48 (73%) completed the study. Eight participating clinics chose to receive foundational support only (12%) while 58 chose to engage in supplemental support (88%) activities. Clinics that received supplemental support and completed the intervention (n = 42) engaged in practice facilitation (Mean: 293 min, range: 75–550 min); data review (38%), HIT support (31%), expert consultation (19%), and peer-to-peer learning (5%). Pre- and post-intervention assessments showed significant improvement in self-reported SBIRT process outcomes. Performance data improved among the subset of completing clinics able to produce data (n = 17). Clinics described positive experiences with ANTECEDENT support and highlighted remaining barriers to SBIRT and MAUD implementation. Participating clinics engaged in a diverse range of supportive activities. A flexible approach using practice facilitation and implementation support could be helpful for low-resourced primary care clinics in improving SBIRT and MAUD for unhealthy alcohol use.