Focus on Fidelity: Delivering What's Intended in a Multi-Site Randomized Clinical Trial

Purpose: Intervention fidelity, the degree to which an intervention study is carried out as proposed, is critical to ensuring internal validity, reliability and generalizability of research findings (Gearing et al., 2011; Goense, Boendermaker, & von Yperen, 2016). Unfortunately, intervention fidelity is infrequently reported in the research literature (Corely & Kim, 2016; Stone 2015). The absence of intervention fidelity reporting may contribute to dissemination of potentially low-efficacy or ineffective interventions into clinical practice. The purpose of this abstract is to explicate the strategies used to assess and monitor intervention fidelity in an ongoing multi-site clinical trial. The intervention fidelity strategies used in the current study were guided by best practice recommendations put forth by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium (BCC) (Bellg et al., 2004). The BCC’s recommendations encompass five strategy domains: (1) study design, (2) facilitator training, (3) intervention delivery, (4) intervention receipt, and (5) intervention enactment.

Methods: Strategies promoting intervention fidelity were developed a priori for use in a multi-site randomized clinical trial testing the efficacy of a computer-assisted cognitive rehabilitation intervention for adults with multiple sclerosis. Data were collected continuously throughout the study to assess and monitor intervention fidelity related to study design, facilitator training, intervention delivery, and intervention enactment.

Results: Fidelity data from 10 cohorts were gathered throughout the study’s 8-week long intervention and again at 2 and 4-months after the intervention ended. Data were extracted from audio-recordings of intervention sessions, session attendance records, audits of computer exercises completed at home by the participants, and post-intervention goal attainment scaling that suggested reasonably high fidelity to the intervention protocol.

Conclusion: This research project demonstrates how nurse researchers may examine and report intervention fidelity guided by best-practice recommendations. Detailed attention to, and documentation of, intervention fidelity strategies may serve to promote scientific rigor in future studies and foster translation of effective interventions into nursing practice.