Discussion
Infection, CRC
RECRUITMENT, INFECTION
The overall goal of this study is to evaluate the implementation and effectiveness of the mPATH™ program. While this overarching goal has not changed over time, many study details have been revised from the initial study conception. Changes were made based on formative work prior to the launch of the trial, and out of necessity because of the COVID-19 pandemic.mPATH-CRC™ was initially conceived as a single program that included both questions used to identify whether patients were due for CRC screening, as well as the CRC module (CRC screening decision aid and the ability to “self-order” a screening test) for patients who are due for screening. However, based on feedback provided by clinic staff through focus groups and semi-structured interviews [The initial version of this study included a planned sample size of 28 clinics from both North Carolina (clinics affiliated with Atrium Health Wake Forest Baptist) and Kentucky (federally-qualified health centers). Implementation of mPATH™ in clinics was to start in North Carolina clinics first, with plans to expand to Kentucky later in the study. The two pilot clinics for this study were launched between August and October 2019, and the first clinic in the main trial was launched in November 2019. In March 2020, the trial had to be suspended because of the COVID-19 pandemic. At the time of suspension, 6 clinics had been randomized in the main trial (all in North Carolina); 4 clinics had been using mPATH™ for more than a month and 2 had been using mPATH™ for less than a week. The trial had to be suspended because elective procedures, including screening colonoscopies, were stopped at Atrium Health Wake Forest Baptist, which would impact the effectiveness outcomes for the trial. In addition, there were concerns around transmission of COVID-19 from using iPads in the clinics, patients not coming in to primary care clinics for routine clinical care, and added burden to clinic staff whose focus needed to be on patient care, not the trial. While the study team had initially hoped to resume the trial in Summer 2020 after elective procedures had restarted and some of the backlog was cleared, this was not possible given local spikes in COVID-19 and continuing concerns around implementation in primary care clinics.By the beginning of 2021, there was general agreement between the study team and participating clinics that it was safe to resume the implementation of mPATH™ in primary care clinics. Vaccines were starting to be available, society had adapted to the pandemic, and other shared touchscreens were being used in outpatient settings. Based on this, a pilot clinic agreed to be re-launched in February 2021, and the main trial resumed in March 2021. With re-launch, mPATH™ iPad cleaning procedures were developed and approved by the Atrium Health Wake Forest Baptist Infection Control office and all mPATH™ iPads were enclosed in antimicrobial cases to ensure the safety of all involved. However, because the trial was suspended for a full year, there had been minimal data collection prior to the suspension, and there had been a lot of staff turnover at the study clinics, the study team decided that the best course of action was to start the study over at the time of re-launch (i.e., no data collected prior to re-launch will be used in final analyses for the trial). This included re-training the staff and collecting new baseline surveys. Clinics who were already in the study were not re-randomized (i.e., their assignment to either “high touch” or “low touch” stayed the same), but the time clock started over at the time of re-launch.While the trial was able to be resumed in the North Carolina clinics, adding clinics in Kentucky was still a problem because of a travel restriction that was in place for Atrium Health Wake Forest Baptist employees. This meant that the study team with technical knowledge of the mPATH™ program would not the be able to travel to Kentucky for on-site implementation support. Given this logistical challenge, the study team made the difficult decision to restrict enrollment to only those clinics affiliated with Atrium Health Wake Forest Baptist. With the loss of both the Kentucky clinics and a year of time, the planed sample size was reduced from 28 clinics to 22 clinics, with approval from the NCI. Clinic recruitment was a challenge after re-launch, given the continuing pandemic and the reluctance of clinics to start something new during this difficult time. Despite this, 14 additional clinics were recruited and enrolled in the study after re-launch. Two of the original study clinics declined to participate at the time of re-launch (so will not contribute any data to the final analysis), leaving a final total sample size of 18 study clinics. Both clinics that declined to re-launch had been in the “low touch” arm. While this is a smaller sample size than intended, there is still at least 80% power to detect a difference of 20% in the primary outcome of Reach of mPATH™-CRC between implementation strategies even if the ICC is as high as 0.06. With 18 clinics there is also 82% power to detect a 10% difference in screening rates (15% vs 25%) pre- vs post-implementation, and an interaction OR of 3.3 can be detected to evaluate whether the effect of mPATH™-CRC on screening rates differs by implementation strategy when the ICC is 0.03. Therefore, despite the major challenges of conducting a trial during the COVID-19 pandemic, and all of the changes that are required, the current version of the study is still able to answer important questions around the implementation of the mPATH™ program and its effectiveness in improving screening rates for CRC. In addition, this work has the potential to have an even broader impact by identifying strategies to support the sustained use of other similar technology-based primary care interventions.