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Sunday, November 1, 2009
Learning Objective 1: Gain an understanding of the importance of ongoing quality assurance of intervention fidelity.
Learning Objective 2: Understand a methodology of intervention quality assurance
Significance/Purpose: Behavioral intervention effectiveness in randomized controlled trials requires fidelity to a research protocol. The purpose of this study is to describe tool development for assessment of intervention delivery quality assurance.
Methods: A tool was developed to evaluate completeness of intervention delivery, which addressed whether key components were covered at each intervention session. First, input was solicited from the nurse interventionists regarding the intervention protocol and their needs-assessment process. Additional collaboration was sought from the PI, project director, and other research team members. From these discussions, a checklist for percentage of agreement (POA) assessment was developed and pilot-tested by evaluating audio-recorded interventions sessions with field notes available for three randomly selected subjects. Tool revisions were made according to assessment findings and further discussion with the PI and the project director. This process was repeated until a review tool was finalized. In addition, an existing visual analog scale providing global ratings of interaction characteristics of both the interventionist and subject with respect to engagement, demeanor, listening skills, attentiveness, and openness was used.
Results: Audio-recorded, individualized behavioral interventions for medication adherence were telephone-delivered for persons with HIV/AIDS taking oral anti-retroviral therapy. Subject consent was obtained prior to audio-recording each session. All interventions received by 120 subjects were eligible for review. A random selection of 10% (n=12) of subjects, stratified by interventionist and gender, comprised the sample; two-thirds of the sample was male (66.67%) and over half was non-white (58.33%). The average age was 47.33 years; subjects completed an average of 11 individualized interventions. Review of POA and quality of interaction is ongoing. Further analyses will include review of remaining sessions and provide individual assessments of interventionists.
Conclusions: Monitoring of study implementation is critical; ongoing quality assurance is necessary in order to ensure study protocol is followed and study results are reliable.