Guidance for conducting feasibility and pilot studies for implementation trials

Background Implementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials. Methods We convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies. Conclusions This paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.

An effectiveness-implementation hybrid trial for informatics-based cancer symptom management.

236 Background: Oncology outpatients can facesignificant cancer- and treatment-related symptoms that compromise health related quality of life and quality health care. Although the burden of symptoms on patients’ lives are well-known, most health care systems are not ideally set up to relieve them. Patients are not typically drawn into meaningful engagement with the health care team in ways that enable symptom self-management. As a result, opportunities for early identification and treatment are lost, causing avoidable human suffering and cost. The Northwestern University IMPACT (NU IMPACT) project aims to evaluate the effectiveness and implementation of an informatics-driven symptom monitoring and web-based self-management intervention. The project uses PROMIS measures, integrated into the EHR, to trigger response and intervention. This presentation describes the effectiveness-implementation hybrid trial design and measurement of implementation. Methods: NU IMPACT will test the effectiveness and implementation of a system-wide symptom management intervention, across six adult hematology/oncology and gynecologic oncology outpatient clinics at Northwestern Memorial HealthCare, using a cluster randomized pragmatic roll-out implementation trial with an embedded individual-level randomized clinical trial. This unique design allows for a fully-powered randomized trial to establish the efficacy of the intervention, as well as a randomized test of implementation. We are enrolling approximately 6,000 patients in pre-implementation and 6,000 in post-implementation, with half of the latter group randomly assigned to enhanced symptom management, and the other half to usual care. Results: Implementation process is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model with evaluation following the RE-AIM framework. Particular focus is paid to adoption at the clinic and provider levels, the extent to which the intervention achieves meaningful reach to cancer patients, and the potential for sustainment. Additionally, we are testing and validating a newly developed method for tracking and reporting dynamic changes to implementation strategies. Conclusions: Achieving the aims of the NU IMPACT project is a critical step in the advancement of informatics-driven symptom management interventions for cancer patients. The innovative implementation trial design and measurement approach will aid in the rapid translation of findings to other healthcare systems. Clinical trial information: NCT03988543 .

Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision—ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.