Dawn Frambes1, Rebecca Lehto2, Alla Sikorskii3, Irena Tesnjak4, Barbara Given2, Gwen Wyatt2. 1. Department of Nursing, Calvin College, Grand Rapids, MI, USA. 2. College of Nursing, Michigan State University, East Lansing, MI, USA. 3. College of Nursing, University of Arizona, Tucson, AR, USA. 4. Department of Statistics and Probability, Michigan State University, East Lansing, MI, USA.
Abstract
AIM: To evaluate and quantify the intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for people with breast cancer. BACKGROUND: Studies on caregiver-delivered symptom management interventions seldom include adequate information on protocol fidelity, contributing to potentially suboptimal provision of the therapeutic intervention, hindering reproducibility and generalizability of the results. DESIGN: Fidelity assessment of a 4-week intervention protocol in a randomized controlled trial (RCT) with data collection between 2012 - 2016. METHODS: The National Institutes of Health Behaviour Change Consortium (NIH-BCC) conceptual model for intervention fidelity guided the study. The five NIH-BCC fidelity elements are: (1) dose; (2) provider training; (3) intervention delivery; (4) intervention receipt; and (5) enactment. To illustrate the elements, an intervention protocol was deconstructed and each element quantified using a newly developed fidelity scorecard. RESULTS:Mean scores and frequency distributions were derived for the scorecard elements. For dose, the mean number of sessions was 4·4, 96% used the correct intervention duration and 29% had 4 weeks with at least one session. Provider training was achieved at 80% of the maximum score, intervention delivery was 96%, intervention receipt was 99% and enactment indicated moderate adoption at 3·8 sessions per patient. The sample mean score was 15·4 out of 16, indicating the high overall fidelity. CONCLUSION: Research findings that include description of how fidelity is both addressed and evaluated are necessary for clinical translation. Clinicians can confidently recommend symptom management strategies to patients and caregivers when fidelity standards are explicitly reported and measured.
RCT Entities:
AIM: To evaluate and quantify the intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for people with breast cancer. BACKGROUND: Studies on caregiver-delivered symptom management interventions seldom include adequate information on protocol fidelity, contributing to potentially suboptimal provision of the therapeutic intervention, hindering reproducibility and generalizability of the results. DESIGN: Fidelity assessment of a 4-week intervention protocol in a randomized controlled trial (RCT) with data collection between 2012 - 2016. METHODS: The National Institutes of Health Behaviour Change Consortium (NIH-BCC) conceptual model for intervention fidelity guided the study. The five NIH-BCC fidelity elements are: (1) dose; (2) provider training; (3) intervention delivery; (4) intervention receipt; and (5) enactment. To illustrate the elements, an intervention protocol was deconstructed and each element quantified using a newly developed fidelity scorecard. RESULTS: Mean scores and frequency distributions were derived for the scorecard elements. For dose, the mean number of sessions was 4·4, 96% used the correct intervention duration and 29% had 4 weeks with at least one session. Provider training was achieved at 80% of the maximum score, intervention delivery was 96%, intervention receipt was 99% and enactment indicated moderate adoption at 3·8 sessions per patient. The sample mean score was 15·4 out of 16, indicating the high overall fidelity. CONCLUSION: Research findings that include description of how fidelity is both addressed and evaluated are necessary for clinical translation. Clinicians can confidently recommend symptom management strategies to patients and caregivers when fidelity standards are explicitly reported and measured.
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