Development, assessment, and monitoring of audiologic treatment fidelity in the aging and cognitive health evaluation in elders (ACHIEVE) randomised controlled trial

Abstract

Objective

Studies investigating hearing interventions under-utilise and under-report treatment fidelity planning, implementation, and assessment. This represents a critical gap in the field that has the potential to impede advancements in the successful dissemination and implementation of interventions. Thus, our objective was to describe treatment fidelity planning and implementation for hearing intervention in the multi-site Ageing and Cognitive Health Evaluation in Elders (ACHIEVE) randomised controlled trial.

Design

Our treatment fidelity plan was based on a framework defined by the National Institutes of Health Behaviour Change Consortium (NIH BCC), and included strategies to enhance study design, provider training, and treatment delivery, receipt, and enactment.

Study sample

To assess the fidelity of the ACHIEVE hearing intervention, we distributed a checklist containing criteria from each NIH BCC core treatment fidelity category to nine raters.

Results

The ACHIEVE hearing intervention fidelity plan satisfied 96% of NIH BCC criteria. Our assessment suggested a need for including clear, objective definitions of provider characteristics and non-treatment aspects of intervention delivery in future fidelity plans.

Conclusions

The ACHIEVE hearing intervention fidelity plan can serve as a framework for the application of NIH BCC fidelity strategies for future studies and enhance the ability of researchers to reliably implement evidence-based interventions.

Keywords:

• Hearing intervention
• multi-site clinical trial
• fidelity
• quality assurance
• quality control

Acknowledgments

The authors give special recognition for significant contributions to the study including help with data collection, entry, and management: Laura Westermann, Haley Neil, Taylor Nye, Emily Bethune, and Preyanca H. Oree. The authors also give special recognition to those that reviewed and/or supported portions of this project including Jennifer Deal, Adele Goman, and Sheila Burgard.

Disclosure statement

Dr. Sanchez reports paid consultation work unrelated to the present project from Autifony Therapeutic Ltd., and Otonomy, LLC. Dr. Lin reports prior paid consultation unrelated to the present project from Amplifon and Frequency Therapeutics.

Ethics approval

Human subjects approvals for the multi-site clinical trial described in this manuscript were obtained from the University of South Florida, Johns Hopkins University, University of Mississippi, Wake Forest University, University of North Carolina, and University of Minnesota Institutional Review Boards (IRBs) prior to any participant recruitment or other study-related activities.

Consent to participate

All human subjects involved in the multi-site clinical trial described in this manuscript underwent an IRB-approved informed consent process prior to engaging in any study-related activities.

Consent for publication

All co-authors provided their consent to publish this work prior to submission.

Data availability statement

Data related to the treatment fidelity plan described in this manuscript are available upon request by contacting the corresponding author at [email protected].

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Michelle Arnold, Victoria Sanchez, Nicholas Reed, Sarah Faucette, Laura Sherry, Kaila Higuchi, Kerry Witherell, and Elizabeth Anderson. The first draft of the manuscript was written by Michelle Arnold and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Additional information

Funding

This work was supported by NIH-NIA (R01AG055426, R34AG046548). Hearing aids, hearing assistive technologies, and related materials were donated in-kind to this study by Sonova IG/Phonak LLC, under a research supply agreement Johns Hopkins University. Sonova IG/Phonak LLC did not participate in the design, data collection or analysis, or development of this manuscript. Portions of this work were presented at the American Auditory Society, 2016, Scottsdale, AZ; the World Congress of Audiology, September 2017, Vancouver Canada; and The Florida Academy of Audiology, August 2018; Orlando, Florida.