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Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial
BACKGROUND: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance imp...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7161112/ https://www.ncbi.nlm.nih.gov/pubmed/32299515 http://dx.doi.org/10.1186/s13063-020-4180-z |
| _version_ | 1783522891636146176 |
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| author | Mackay, T. M. Smits, F. J. Latenstein, A. E. J. Bogte, A. Bonsing, B. A. Bos, H. Bosscha, K. Brosens, L. A. A. Hol, L. Busch, O. R. C. Creemers, G. J. Curvers, W. L. den Dulk, M. van Dieren, S. van Driel, L. M. J. W. Festen, S. van Geenen, E. J. M. van der Geest, L. G. de Groot, D. J. A. de Groot, J. W. B. Haj Mohammad, N. Haberkorn, B. C. M. Haver, J. T. van der Harst, E. Hemmink, G. J. M. de Hingh, I. H. Hoge, C. Homs, M. Y. V. van Huijgevoort, N. C. Jacobs, M. A. J. M. Kerver, E. D. Liem, M. S. L. Los, M. Lubbinge, H. Luelmo, S. A. C. de Meijer, V. E. Mekenkamp, L. Molenaar, I. Q. van Oijen, M. G. H. Patijn, G. A. Quispel, R. van Rijssen, L. B. Römkens, T. E. H. van Santvoort, H. C. Schreinemakers, J. M. J. Schut, H. Seerden, T. Stommel, M. W. J. ten Tije, A. J. Venneman, N. G. Verdonk, R. C. Verheij, J. van Vilsteren, F. G. I. de Vos-Geelen, J. Vulink, A. Wientjes, C. Wit, F. Wessels, F. J. Zonderhuis, B. van Werkhoven, C. H. van Hooft, J. E. van Eijck, C. H. J. Wilmink, J. W. van Laarhoven, H. W. M. Besselink, M. G. |
| author_facet | Mackay, T. M. Smits, F. J. Latenstein, A. E. J. Bogte, A. Bonsing, B. A. Bos, H. Bosscha, K. Brosens, L. A. A. Hol, L. Busch, O. R. C. Creemers, G. J. Curvers, W. L. den Dulk, M. van Dieren, S. van Driel, L. M. J. W. Festen, S. van Geenen, E. J. M. van der Geest, L. G. de Groot, D. J. A. de Groot, J. W. B. Haj Mohammad, N. Haberkorn, B. C. M. Haver, J. T. van der Harst, E. Hemmink, G. J. M. de Hingh, I. H. Hoge, C. Homs, M. Y. V. van Huijgevoort, N. C. Jacobs, M. A. J. M. Kerver, E. D. Liem, M. S. L. Los, M. Lubbinge, H. Luelmo, S. A. C. de Meijer, V. E. Mekenkamp, L. Molenaar, I. Q. van Oijen, M. G. H. Patijn, G. A. Quispel, R. van Rijssen, L. B. Römkens, T. E. H. van Santvoort, H. C. Schreinemakers, J. M. J. Schut, H. Seerden, T. Stommel, M. W. J. ten Tije, A. J. Venneman, N. G. Verdonk, R. C. Verheij, J. van Vilsteren, F. G. I. de Vos-Geelen, J. Vulink, A. Wientjes, C. Wit, F. Wessels, F. J. Zonderhuis, B. van Werkhoven, C. H. van Hooft, J. E. van Eijck, C. H. J. Wilmink, J. W. van Laarhoven, H. W. M. Besselink, M. G. |
| author_sort | Mackay, T. M. |
| collection | PubMed |
| description | BACKGROUND: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. METHODS/DESIGN: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. DISCUSSION: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018. |
| format | Online Article Text |
| id | pubmed-7161112 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2020 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-71611122020-04-22 Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial Mackay, T. M. Smits, F. J. Latenstein, A. E. J. Bogte, A. Bonsing, B. A. Bos, H. Bosscha, K. Brosens, L. A. A. Hol, L. Busch, O. R. C. Creemers, G. J. Curvers, W. L. den Dulk, M. van Dieren, S. van Driel, L. M. J. W. Festen, S. van Geenen, E. J. M. van der Geest, L. G. de Groot, D. J. A. de Groot, J. W. B. Haj Mohammad, N. Haberkorn, B. C. M. Haver, J. T. van der Harst, E. Hemmink, G. J. M. de Hingh, I. H. Hoge, C. Homs, M. Y. V. van Huijgevoort, N. C. Jacobs, M. A. J. M. Kerver, E. D. Liem, M. S. L. Los, M. Lubbinge, H. Luelmo, S. A. C. de Meijer, V. E. Mekenkamp, L. Molenaar, I. Q. van Oijen, M. G. H. Patijn, G. A. Quispel, R. van Rijssen, L. B. Römkens, T. E. H. van Santvoort, H. C. Schreinemakers, J. M. J. Schut, H. Seerden, T. Stommel, M. W. J. ten Tije, A. J. Venneman, N. G. Verdonk, R. C. Verheij, J. van Vilsteren, F. G. I. de Vos-Geelen, J. Vulink, A. Wientjes, C. Wit, F. Wessels, F. J. Zonderhuis, B. van Werkhoven, C. H. van Hooft, J. E. van Eijck, C. H. J. Wilmink, J. W. van Laarhoven, H. W. M. Besselink, M. G. Trials Study Protocol BACKGROUND: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. METHODS/DESIGN: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. DISCUSSION: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018. BioMed Central 2020-04-16 /pmc/articles/PMC7161112/ /pubmed/32299515 http://dx.doi.org/10.1186/s13063-020-4180-z Text en © The Author(s). 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| spellingShingle | Study Protocol Mackay, T. M. Smits, F. J. Latenstein, A. E. J. Bogte, A. Bonsing, B. A. Bos, H. Bosscha, K. Brosens, L. A. A. Hol, L. Busch, O. R. C. Creemers, G. J. Curvers, W. L. den Dulk, M. van Dieren, S. van Driel, L. M. J. W. Festen, S. van Geenen, E. J. M. van der Geest, L. G. de Groot, D. J. A. de Groot, J. W. B. Haj Mohammad, N. Haberkorn, B. C. M. Haver, J. T. van der Harst, E. Hemmink, G. J. M. de Hingh, I. H. Hoge, C. Homs, M. Y. V. van Huijgevoort, N. C. Jacobs, M. A. J. M. Kerver, E. D. Liem, M. S. L. Los, M. Lubbinge, H. Luelmo, S. A. C. de Meijer, V. E. Mekenkamp, L. Molenaar, I. Q. van Oijen, M. G. H. Patijn, G. A. Quispel, R. van Rijssen, L. B. Römkens, T. E. H. van Santvoort, H. C. Schreinemakers, J. M. J. Schut, H. Seerden, T. Stommel, M. W. J. ten Tije, A. J. Venneman, N. G. Verdonk, R. C. Verheij, J. van Vilsteren, F. G. I. de Vos-Geelen, J. Vulink, A. Wientjes, C. Wit, F. Wessels, F. J. Zonderhuis, B. van Werkhoven, C. H. van Hooft, J. E. van Eijck, C. H. J. Wilmink, J. W. van Laarhoven, H. W. M. Besselink, M. G. Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial |
| title | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial |
| title_full | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial |
| title_fullStr | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial |
| title_full_unstemmed | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial |
| title_short | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial |
| title_sort | impact of nationwide enhanced implementation of best practices in pancreatic cancer care (pacap-1): a multicenter stepped-wedge cluster randomized controlled trial |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7161112/ https://www.ncbi.nlm.nih.gov/pubmed/32299515 http://dx.doi.org/10.1186/s13063-020-4180-z |
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