TY - JOUR
T1 - Assessing adherence, competence and differentiation in a stepped-wedge randomised clinical trial of a complex behaviour change intervention
AU - Beck, Alison Kate
AU - Baker, Amanda L.
AU - Carter, Gregory
AU - Wratten, Chris
AU - Bauer, Judith
AU - Wolfenden, Luke
AU - McCarter, Kristen
AU - Britton, Ben
N1 - Funding Information:
Funding: This paper presents fidelity outcomes from a study that was funded by the National Health and Medical Research Council (APP1021018; 2011/3654).
Funding Information:
Acknowledgments: The authors would like to acknowledge the support of The Trans-Tasman Radiation Oncology Group (TROG), The Calvary Mater Newcastle Nutrition and Dietetics Department, and the research, dietetic, and oncology staff at participating sites. We also wish to thank project staff including Erin Forbes and Katrina Bell.
Publisher Copyright:
© 2020 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2020/8
Y1 - 2020/8
N2 - Background: A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). Purpose: To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of “EAT: Eating As Treatment”, a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Methods: Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. Results: Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. Conclusions: Although what level of fidelity is “good enough” remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.
AB - Background: A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). Purpose: To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of “EAT: Eating As Treatment”, a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Methods: Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. Results: Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. Conclusions: Although what level of fidelity is “good enough” remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.
KW - Behaviour change counselling
KW - Behavioural medicine
KW - Fidelity
KW - Head and neck cancer
KW - Motivational interviewing
KW - Translational research
UR - http://www.scopus.com/inward/record.url?scp=85089171268&partnerID=8YFLogxK
U2 - 10.3390/nu12082332
DO - 10.3390/nu12082332
M3 - Article
C2 - 32759848
AN - SCOPUS:85089171268
VL - 12
JO - Nutrients
JF - Nutrients
SN - 2072-6643
IS - 8
M1 - 2332
ER -