Adaptations to Acupuncture and Pain Counseling Implementation in a Multisite Pragmatic Randomized Clinical Trial.

As part of a pragmatic effectiveness trial of integrative pain management among inpatients with cancer, the authors sought to understand the clinical context and adaptations to implementation of two study interventions, acupuncture and pain counseling (i.e., pain education and coping skills). The larger study uses a 2 × 2 factorial design with inpatients randomized to: (1) usual care (UC), (2) UC with acupuncture, (3) UC with pain counseling, and (4) UC with acupuncture and pain counseling. The study is being conducted in two hospitals (one academic and one public) and three languages (Cantonese, English, and Spanish). The authors conducted a process evaluation by interviewing study interventionists. Analysis included deductive coding to describe context, intervention, implementation, and inductive thematic coding related to intervention delivery. Interviewees included seven acupuncturists and four pain counselors. Qualitative themes covered adaptations and recognizing site-specific differences that affected implementation. Interventionists adhered closely to protocols and made patient-centered adaptations that were then standardized in broader implementation (e.g., including caregivers in pain counseling sessions; working in culturally nuanced ways with non-English-speaking patients). The public hospital included more patients with recent diagnoses and advanced disease, more ethnically and linguistically diverse patients, less continuity of staffing, and shared patient rooms. At the academic medical center, more patients were familiar with integrative therapies and all were located in single rooms. Providing acupuncture to hospital staff was a key strategy to establish trust, experientially explain the intervention, and create camaraderie and staff buy-in. Providing nonpharmacologic interventions for a pragmatic trial requires adapting to a range of clinical factors. Site-specific factors included greater coordination and resources needed for successful implementation in the public hospital. The authors conclude that adaptation to context and individual patient needs can be done without compromising intervention fidelity and that intervention design should apply principles such as centering at the margins to reduce participation barriers for diverse patient populations.