Sunday, November 1, 2009
Melissa B. Evans
Melissa L. Knox
Lisa Tamres, MS
Judith A. Erlen, RN, PhD, FAAN
Health Promotion and Development, University of Pittsburgh School of Nursing, Pittsburgh, PA
Learning Objective 1: understand the importance of soliciting feedback from study participants in order to improve future research and interventions.
Learning Objective 2: understand specific feedback received in a randomized intervention study.
Important information is obtained by evaluating participants’ experience in clinical trials. This information is useful for investigators to improve the quality of research and of interventions. This study examines the experience of 178 participants who completed a NIH funded clinical trial (R01 NR04749) who were randomized to receive either adherence counseling or usual care. Intervention participants completed twelve weeks of a telephone-delivered nurse counseling intervention and remained in the study for an additional fifteen months of follow-up. All participants were monitored for adherence using medication pill bottles with electronic event monitors (EEMs), paper and pencil diaries, and several self-report questionnaires. An exit interview occurred at the study’s conclusion. Two raters evaluated the exit interviews to assess participants’ satisfaction with the study, and their perception of study benefits. Ratings were compared and disagreements between the two raters were reconciled by a third rater.
Preliminary results show that the majority (83%) of all participants commented positively on the study. Positive comments related to the intervention providing functional and emotional support, such as improving schedules, setting goals, proper medication dosing, and social contact. Negative comments included burden of study questionnaires, intervention scheduling, perceived redundancy of study measures, and use of the pill bottles with EEMs. Overall, 47% identified a benefit of improved adherence in response to an open-ended question on study benefits. Notably, usual care participants reported this perceived adherence improvement as often or more than the intervention participants (51% vs 48%).
These findings suggest that study participation may have been perceived as an intervention even by the usual care group. Participant experience might be improved by limiting burden and better technology for monitoring medication adherence. Limitations to the current study include the lack of assessment of study dropouts’ perceptions, and the length of time from the intervention to the exit assessment.
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