Design |
Ensure same treatment dose within different settings |
Development of a standard protocol for counseling to administer at military hospitals across the country by audiologists with differences in previous experience in treating patients with tinnitus. |
Ensure equivalent dose across conditions |
Counseling conducted at treatment visits conducted within 2 months following randomization and a follow-up treatment visit 1 month later. |
Plan for implementation setbacks |
Standard certification requirements for replacement of study audiologists during the trial. |
Training providers |
Standardize training |
Completion of training by reading relevant sections of the TRTT Manual of Procedures and (1) attendance at a two-day regional training session, (2) attendance at a webinar, or (3) viewing a videotape of a counseling session. |
Ensure provider skill acquisition |
Competency assessed through submission of a “dummy” audiotape of each type of counseling session for review by the protocol monitors |
Minimize “drift” in provider skills |
Submission of randomly selected audiotapes during the trial for review by protocol monitors. |
Accommodate provider differences |
Scripts with suggested wording for both types of counseling, but with allowances for individual styles. |
Monitoring and improving delivery of treatment |
Control for provider differences |
Checklists used to ensure adherence to critical components. |
Reduce difference within treatment |
Separate scripts and visual aids to be used during counseling sessions including an instructive flip chart and 3-D ear models. |
Ensure adherence to treatment protocol |
Submission of audiotapes and checklists of first two of each type of counseling session for review by protocol monitors; submission of randomly selected audiotapes and checklists after sessions initially reviewed. |
Minimize contamination between conditions |
Separate checklists and scripts for each type of counseling session. |
Improving receipt of treatment |
Ensure participant comprehension |
Interactive sessions with opportunity for questioning both by participant and family. |
Ensure participant ability to use cognitive skills |
Handouts that summarized concepts covered during counseling that participants could take home. |
Ensure participant ability to perform behavioral skills |
Practice during the counseling session and handouts that included symptom management strategies to be practiced following the session. |
Enactment of treatment skills |
Ensure participant use of cognitive and behavioral skills |
Assessment of impact of tinnitus through administration of tinnitus-specific health-related quality of life instruments |