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.

doi:10.1186/s13063-020-4180-z

Trials

Table 3 List of PACAP-1 interventions per medical specialty

From: Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial

Medical oncology
	Intervention	Definition	Outcome	Measurement
1	Standard information and decision support tool	Use of standard information and decision support tool for all pancreatic cancer patient subgroups (e.g., via https://bit.do/beslisboom)	Survival	NCR
2	Discussion on chemotherapy (resectable patients)	Percentage of resectable pancreatic cancer patients with whom Chemotherapy options are discussed in DPCG center	Survival Quality of life	NCR PROMs DPCA
3	Diagnostics LAPC patient established in DPCG center	Percentage of LAPC patients in the diagnostic phase that are discussed in DPCG MDT meeting	Survival Quality of life	NCR PROMs DPCA
4	Post-induction chemotherapy discussion of LAPC patient in DPCG center	Percentage of LAPC patients treated with chemotherapy that are discussed in DPCG MDT meeting after 2 months of therapy	Survival Quality of life	NCR PROMs DPCA
5	PERT	Percentage of patients with EPI who receive PERT	Survival Quality of life	NCR PROMs
6	Key parameter WHO performance status reporting	Percentage of patients with a (suspected) pancreatic malignancy, in whom the WHO performance status is reported at first presentation.	–	NCR DPCA
7	Pre-treatment pathology confirmation	Percentage of patients with (suspected) locally advanced and metastatic pancreatic cancer, with histological or cytological proof of pancreatic adenocarcinoma	–	NCR
8	PROMs	Percentage of patients with a (suspected) pancreatic malignancy who are registered for the PACAP PROMs	–	PROMs
9	Biobanking	Percentage of patients receiving pancreatic resection for suspected malignancy who are registered for the PancreasParel	–	PancreasParel
Surgery
	Intervention	Definition	Outcome	Measurement
1	Medical oncology referral	Percentage of patients with pancreatic cancer referred to medical oncologist for consultation on adjuvant chemotherapy	Survival Quality of life	NCR PROMs
2	PERT	Percentage of patients with EPI who receive PERT	Survival Quality of life	NCR PROMs
3	Synoptic discharge letter	Percentage of patients receiving pancreatic resection for a (suspected) malignancy in whom the synoptic complication table is used in the discharge letter	–	DPCA
4	Synoptic POC	Percentage of patients undergoing pancreatic resection in whom the synoptic POC is used in the operation report	–	DPCA
5	PROMs	Percentage of patients receiving pancreatic resection for (suspected) malignancy who are registered for the PACAP PROMs	–	PROMs
6	Biobanking	Percentage of patients receiving pancreatic resection for (suspected) malignancy who are registered for the PancreasParel	–	PancreasParel
7	Standardized complication management	Standardized approach to early detection and treatment of pancreatic fistula (PORSCH trial)	Postoperative complications	DPCA PROMs PORSCH
Gastroenterology
	Intervention	Intervention	Outcome	Measurement
1	Metal stent	Percentage of patients with a (suspected) pancreatic malignancy requiring biliary drainage receiving a metal (rather than a plastic) stent	Complications	NCR DPCA
2	PERT	Percentage of patients with EPI who receive PERT	Survival Quality of life	NCR PROMs
3	Pre-treatment pathology confirmation	Percentage of patients with (suspected) locally advanced and metastatic pancreatic cancer with histological or cytological proof of pancreatic adenocarcinoma	–	NCR
Pathology
	Intervention	Definition	Outcome	Measurement
1	Synoptic reporting	Percentage of patients receiving pancreatic resection for a suspected malignancy in whom the resection specimen is recorded according to the PALGA/Dutch Society of Pathology nationwide synoptic report	Number of R1 resections	DPCA
Radiology
	Intervention	Definition	Outcome	Measurement
1	Synoptic reporting	Percentage of patients with a (suspected) pancreatic in whom the computed tomography (CT) is recorded according to the Dutch Society of Radiology CT-checklist	–	DPCA

Abbreviations: NCR Netherlands Cancer Registry, PROMS patient reported outcome measures, DPCA Dutch Pancreatic Cancer Audit, DPCG Dutch Pancreatic Cancer Group, LAPC locally advanced pancreatic cancer, MDT multidisciplinary team, PERT pancreatic enzyme replacement therapy, EPI exocrine pancreatic insufficiency, WHO World Health Organization, PACAP Dutch Pancreatic Cancer Project, POC postoperative conclusion, PALGA nationwide network and registry of histo- and cytopathology of the Netherlands

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ISSN: 1745-6215

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