Study Design
The RE-AIM framework was used to evaluate a randomized controlled trial (Clinicaltrials.gov identifier: NCT02272244) of an intervention aimed at increasing CRC screening rates among Hispanics (Myers 2019). Patients were randomized to an SI group (n = 203) or a DSNI group (n = 197). The SI included a mailed stool blood test (SBT) and instructions for completion in English and Spanish. The DSNI intervention included a SI plus telephone decision support and navigation by a bilingual patient assistant who reviewed the screening materials, verified the participant’s preferred CRC screening test, and assessed the individual’s likelihood of completing his/her preferred test. The goal of this intervention was to increase rates of colon cancer screening for Hispanic primary care patients. The patient navigator assisted DSNI participants to develop and implement a test-specific screening plan.
Primary care clinicians received documentation of all patient contacts via the electronic medical record in addition to the screening decision, status, and results. All participants’ SBT results were routed to the clinician, and the patient was contacted by the practice protocol per usual care. The navigator encouraged and assisted participants with a positive index SBT result in undergoing a diagnostic colonoscopy. A 6-month telephone survey was administered and a 6-month and 12-month medical record review was conducted for all participants. A Patient and Stakeholder Advisory Committee (PASAC) comprised of primary care patients, community leaders, and providers oversaw this process.
Setting
This study was conducted within a large Pennsylvania health system that covers urban, suburban, and rural regions. The system serves 800,000 individuals who receive care in over 160 physician practices and 17 community clinics.
Population
Five participating primary care practices used the electronic medical record to identify potential participants, which included a sampling frame of 2,720 Hispanic patients eligible for screening. Eligibility criteria for the population included an age of 50-75 years, no history of CRC or polyps, and not up to date with CRC screening.
RE-AIM Procedures
Reach. Reach was defined as the characteristics of the participants as compared to the sampling frame and the percentage of those randomized to the DSNI arm who received navigation contact. Intervention reach was assessed at the patient level in terms of the number/percentage of study participants who received the planned intervention contacts as compared to those who were eligible to receive such contacts. Reach was assessed based on the selection of participants who were enrolled in the first cohort (N = 2,345) of patients.
Intervention reach was assessed at the provider level and defined as the number/percentage of providers who received participant screening plans and reports. At the provider level, data was collected to track delivery of the patients’ decision summary as well as patient screening status report.
Effectiveness. Effectiveness was defined as CRC screening adherence rates. Intervention effectiveness was measured at the patient level in terms of impact on defined primary outcomes (i.e., screening adherence, screening decision stage, and test-specific adherence). Data from the 6-month survey, 6-month medical records review, and 12-month medical record reviews were used to evaluate this dimension.
Adoption. Adoption was defined as the number of practice participants who agreed to participate and completed the intervention. Characteristics collected include panel size and demographics, staffing, baseline screening rates, ownership, location specialty, and support services.
Implementation. Implementation was defined as the patient contacts for those in the DSNI arm. Intervention implementation was examined using quantitative and qualitative methods throughout project development, implementation, and analysis (Figure 1).
[Insert Figure 1. Implementation examination process]
Quantitative data collection. Navigation call metrics were measured. The number, timing, and length of attempted and completed navigator calls were measured, including whether calls were conducted within or outside of regular business hours, in an effort to identify times of increased opportunity and success. Other metrics evaluated included time from initial mailing to call initiation to call completion and reasons for incomplete calls or navigation refusals. In addition, navigators were asked about their experiences in delivering intervention contacts to participants and providers. Mail and telephone records, along with navigator logs, were used to obtain data to measure this dimension.
Qualitative data collection. Prior to initiation of the randomized trial, qualitative data were collected in two focus groups that were conducted to elicit feedback on implementation strategies for the intervention. Staff recruited focus group participants by working with the health system and local community agencies. Inclusion criteria included individuals who self-reported being of Hispanic ethnicity, ages 50 to 75, having an affiliation with a community group whose mission includes attention to Hispanic/Latino community interests and/or being a patient in the health system. Focus group interactions were audio recorded, transcribed, and content analyzed. The focus groups addressed perceptions of ethnicity and race, study recruitment strategies and procedures, and terms and approach for the navigator. Additional attention was allotted to assess the appropriateness of the drafted educational materials and decision support procedures to be used in the intervention. This assessment included cancer screening content, health literacy, and cultural appropriateness. With each item reviewed, participants’ perceptions about intervention contact along with screening barriers and facilitators was assessed. Group moderators also solicited feedback on the study process.
Interviews were conducted with staff to elicit perceptions related to intervention content and delivery. Barriers and facilitators were discussed to facilitate completion of CRC screening.
Following completion of the randomized trial, focus groups were conducted with DSNI participants and were grouped by CRC screening status (screeners and non-screeners). The focus groups were conducted to elicit feedback on the participant experience of the study intervention, study process, and their reasoning for screening or not screening. Both sessions were conducted mainly in Spanish with limited English-speaking. Focus group interactions were audio recorded, transcribed, and content analyzed.
A PASAC was formed as part of the proposal development process and convened throughout the performance of the project. The PASAC was comprised of Hispanic community members and health system members, including non-study patients, providers and administrators. The primary purpose of this committee was to review processes, procedures, and materials; comment on regular reports of study progress delivered by the academic research team; and provide feedback and recommendations in keeping with both the Patient-Centered Outcomes Research Institute (PCORI) and community-based participatory research principles of community and stakeholder involvement in research.
Maintenance.Maintenance was measured at a systems level due to characteristics of the study via interviews with health system leaders. Maintenance at an individual level was defined as rates of CRC re-screening for those who opted to complete a SBT. Interviews were conducted with select health system leaders to gain insights that would help us to form impressions about the potential for DSNI maintenance in the health system. Thirty-minute interviews were conducted with leaders in the DSNI practices to understand their experience of the intervention and probe its potential continuation after the completion of the research. Three leaders consented to be interviewed: a medical director, community outreach coordinator, and care manager-office coordinator at different sites.
Patient level maintenance was examined using electronic health records data for participants who completed SBT. Subsequent patterns of screening beyond the study’s 12-month observation period was determined. For individuals with a negative index SBT, guidelines would recommend another SBT or a colonoscopy 12 months later; therefore, the rate of rescreening within 15 months (i.e., 12 months plus a 3-month grace period) was analyzed. For individuals with a positive index SBT, rates of a subsequent diagnostic colonoscopy were calculated.
Data Analysis
Descriptive statistics were conducted including frequencies and percentages for categorical variables. Statistical analyses were performed using Excel.
Human Subjects Protection
This study was approved by the Institutional Review Board at [identifying organization name removed].