Abstract
Recent systematic reviews and meta-analyses have reported positive benefit of multicomponent “bundled” palliative care interventions for patients and family caregivers while highlighting limitations in determining key elements and mechanisms of improvement. Traditional research approaches, such as the randomized controlled trial (RCT), typically treat interventions as “bundled” treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced or replaced or whether there are synergistic or antagonistic interactions between intervention components. Progressing toward palliative care interventions that are effective, efficient, and scalable will require new strategies and novel approaches. One such approach is the Multiphase Optimization Strategy (MOST), a framework informed by engineering principles, that uses a systematic process to empirically identify an intervention comprised of components that positively contribute to desired outcomes under real-life constraints. This article provides a brief overview and application of MOST and factorial trial design in palliative care research, including our insights from conducting a pilot factorial trial of an early palliative care intervention to enhance the decision support skills of advanced cancer family caregivers (Project CASCADE).
Original language | English (US) |
---|---|
Pages (from-to) | 174-182 |
Number of pages | 9 |
Journal | Journal of Pain and Symptom Management |
Volume | 62 |
Issue number | 1 |
DOIs | |
State | Published - Jul 2021 |
Funding
The authors would like to thank the UAB Division of Hematology-Oncology clinicians and staff (especially Drs. Lisle Nabell, Gabrielle Rocque, Burt Nabors, Lakshmin Nandagopal, Margaret Liang, Mollie deShazo, Olumide Gbolahan, Susan McCammon, Ravi Puluri, Pankit Vachhani, and Kimo Bachiashvili) and the UAB Division of Geriatrics, Gerontology and Palliative Care for their support of the CASCADE pilot study. In addition, they thank Rhiannon Reed, Erin Currie, Julie Schach, James Mapson, and Gjuana Cleveland for assisting with recruitment, fidelity, and data collection. The authors have no relevant conflicts of interest to disclose. The opinions presented here are those of the authors and do not reflect those of their funding agencies. The CASCADE pilot trial is supported by a National Palliative Care Research Center Pilot Project Support Grant (PI: Dionne-Odom). Dr. Wells is supported by supported by the Agency for Healthcare Research and Quality (T32 HS013852). Dr. Williams is supported in part by the National Cancer Institute of the National Institutes of Health (K08CA234225). Dr. Rosenberg is supported in part by the National Cancer Institute /National Institutes of Health (R01CA22486 and R01CA225629). Dr. Dionne-Odom is supported by the National Institute of Nursing Research (R00NR015903), the National Cancer Institute (R37CA252868), the Betty Irene Moore Foundation, and the National Palliative Care Research Center . The sponsor had no role in design and conduct of this study; ongoing data collection or management; preparation, review, approval of the manuscript; or decision to submit for publication. The authors would like to thank the UAB Division of Hematology-Oncology clinicians and staff (especially Drs. Lisle Nabell, Gabrielle Rocque, Burt Nabors, Lakshmin Nandagopal, Margaret Liang, Mollie deShazo, Olumide Gbolahan, Susan McCammon, Ravi Puluri, Pankit Vachhani, and Kimo Bachiashvili) and the UAB Division of Geriatrics, Gerontology and Palliative Care for their support of the CASCADE pilot study. In addition, they thank Rhiannon Reed, Erin Currie, Julie Schach, James Mapson, and Gjuana Cleveland for assisting with recruitment, fidelity, and data collection. The authors have no relevant conflicts of interest to disclose. The opinions presented here are those of the authors and do not reflect those of their funding agencies. The CASCADE pilot trial is supported by a National Palliative Care Research Center Pilot Project Support Grant (PI: Dionne-Odom). Dr. Wells is supported by supported by the Agency for Healthcare Research and Quality (T32 HS013852). Dr. Williams is supported in part by the National Cancer Institute of the National Institutes of Health (K08CA234225). Dr. Rosenberg is supported in part by the National Cancer Institute/National Institutes of Health (R01CA22486 and R01CA225629). Dr. Dionne-Odom is supported by the National Institute of Nursing Research (R00NR015903), the National Cancer Institute (R37CA252868), the Betty Irene Moore Foundation, and the National Palliative Care Research Center. The sponsor had no role in design and conduct of this study; ongoing data collection or management; preparation, review, approval of the manuscript; or decision to submit for publication.
Keywords
- Multiphase Optimization Strategy
- clinical trials
- factorial experiment
- intervention development
ASJC Scopus subject areas
- Clinical Neurology
- Anesthesiology and Pain Medicine
- General Nursing