Primary: Roberta W. Scherer
Author(s): Roberta W. Scherer Sue Ann Erdman Susan Gold Craig Formby TRTT Research Group
Johns Hopkins Bloomberg School of Public Health University of Alabama
SCT Annual Meeting 2018
Background: Tinnitus, the perception of sound in the absence of external sound, is extremely distressing for some individuals. There are no medical interventions known to alleviate the tinnitus signal, so current treatment options are typically based on minimizing the reaction to and perception of the tinnitus to improve quality of life. The Tinnitus Retraining Therapy Trial (TRTT), conducted at US military hospitals, randomized individuals with severe tinnitus to tinnitus retraining therapy (TRT), Partial TRT or standard of care (SoC). TRT involves tinnitus-specific counseling (TC) and sound therapy. The TRT group used conventional sound generators and the Partial TRT group placebo sound generators to implement sound therapy. SoC involved counseling using a patient-centered care approach. To avoid a counselor effect, study audiologists administered both types of counseling in the TRTT, creating a challenge for managing treatment adherence.
Methods: We developed methods to maintain treatment adherence that involved training, certification, use of scripts and visual aids, and fidelity monitoring. To prepare for certification, protocol monitors identified critical topics for each type of counseling session, prepared scripts, and helped develop checklists covering those topics. Certification required attendance at full-day regional training sessions and review of prepared TC and SoC videos. Audiologists not able to attend a training meeting viewed a webinar or videos that emulated the training session. Study audiologists submitted a voice recording of one TC and one SoC counseling session, each with a non-study individual. Protocol monitors reviewed the recordings, and certified only those audiologists who adhered to the protocol. During the trial, audiologists used treatment-specific aids: scripts, a model of the ear, and handouts for both TC and SoC; and a flip-chart for TC with talking points identified for the counselor. Audiologists completed treatment-specific checklists during each counseling session, indicating topics covered or discussed. They submitted their recordings of the first two study counseling sessions of each type, which the protocol monitors reviewed by completing a separate checklist to verify topics covered. If no deficiencies were noted, then subsequent recordings were randomly selected for review. Whenever deficiencies were noted, the Protocol Monitor communicated with the audiologist in writing and by phone to discuss the deficiency and the next two counseling sessions were submitted for review. Continued non-adherence resulted in de-certification.
Results: 25 audiologists were certified for TC and/or SoC counseling and 24 completed at least one counseling session. Excellent adherence was obtained on 33 items for 74 TC counseling sessions reviewed by the Protocol Monitor (median, 100%, range: 70.3% to 100%), with no difference between adherence for TRT (median, 97.3%) and Partial TRT (median, 100%). Adherence on 44 items for 30 checklists for SoC counseling also showed reasonably good adherence (median, 88.5%, range: 42.3% to 100%).
Conclusion: By using multiple methods to address treatment adherence, the TRTT found audiologists demonstrated fidelity to distinct types of counseling sessions, a critical step in evaluating the efficacy of the study interventions.
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