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

T.M. Mackay; F.J. Smits; A.E.J. Latenstein; A. Bogte; B.A. Bonsing; H. Bos; K. Bosscha; L.A.A. Brosens; L. Hol; O.R.C. Busch; G.J. Creemers; W.L. Curvers; M. den Dulk; S. van Dieren; L.M.J.W. van Driel; S. Festen; E.J.M. van Geenen; L.G. van der Geest; D.J.A. de Groot; J.W.B. de Groot; N.H. Mohammad; B.C.M. Haberkorn; J.T. Haver; E. van der Harst; G.J.M. Hemmink; I.H. de Hingh; C. Hoge; M.Y.V. Homs; N.C. van Huijgevoort; M.A.J.M. Jacobs; E.D. Kerver; M.S.L. Liem; M. Los; H. Lubbinge; S.A.C. Luelmo; V.E. de Meijer; L. Mekenkamp; I.Q. Molenaar; M.G.H. van Oijen; G.A. Patijn; R. Quispel; L.B. van Rijssen; T.E.H. Romkens; H.C. van Santvoort; J.M.J. Schreinemakers; H. Schut; T. Seerden; M.W.J. Stommel; A.J. ten Tije; N.G. Venneman; Dutch Pancreatic Canc Grp; J.M.P.G.M. de Vos-Geelen; M.G. Besselink

doi:10.1186/s13063-020-4180-z

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

T.M. Mackay, F.J. Smits, A.E.J. Latenstein, A. Bogte, B.A. Bonsing, H. Bos, K. Bosscha, L.A.A. Brosens, L. Hol, O.R.C. Busch, G.J. Creemers, W.L. Curvers, M. den Dulk, S. van Dieren, L.M.J.W. van Driel, S. Festen, E.J.M. van Geenen, L.G. van der Geest, D.J.A. de Groot, J.W.B. de GrootN.H. Mohammad, B.C.M. Haberkorn, J.T. Haver, E. van der Harst, G.J.M. Hemmink, I.H. de Hingh, C. Hoge, M.Y.V. Homs, N.C. van Huijgevoort, M.A.J.M. Jacobs, E.D. Kerver, M.S.L. Liem, M. Los, H. Lubbinge, S.A.C. Luelmo, V.E. de Meijer, L. Mekenkamp, I.Q. Molenaar, M.G.H. van Oijen, G.A. Patijn, R. Quispel, L.B. van Rijssen, T.E.H. Romkens, H.C. van Santvoort, J.M.J. Schreinemakers, H. Schut, T. Seerden, M.W.J. Stommel, A.J. ten Tije, N.G. Venneman, Dutch Pancreatic Canc Grp, J.M.P.G.M. de Vos-Geelen, M.G. Besselink^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BackgroundPancreatic 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/designPACAP-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.

Original language	English
Article number	334
Number of pages	18
Journal	Trials
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s13063-020-4180-z
Publication status	Published - 16 Apr 2020

Keywords

best practices
biliary drainage
chemotherapy
design
guidelines
implementation
pancreatic cancer
pancreatic enzyme replacement therapy
quality of life
registry
resection
sample-size
statement
stepped-wedge cluster randomized controlled trial
survival

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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., ... Besselink, M. G. (2020). Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial. Trials, 21(1), Article 334. https://doi.org/10.1186/s13063-020-4180-z

@article{b2829517ea4d46eab899f69a09febf71,

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

abstract = "BackgroundPancreatic 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/designPACAP-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.",

keywords = "best practices, biliary drainage, chemotherapy, design, guidelines, implementation, pancreatic cancer, pancreatic enzyme replacement therapy, quality of life, registry, resection, sample-size, statement, stepped-wedge cluster randomized controlled trial, survival",

author = "T.M. Mackay and F.J. Smits and A.E.J. Latenstein and A. Bogte and B.A. Bonsing and H. Bos and K. Bosscha and L.A.A. Brosens and L. Hol and O.R.C. Busch and G.J. Creemers and W.L. Curvers and {den Dulk}, M. and {van Dieren}, S. and {van Driel}, L.M.J.W. and S. Festen and {van Geenen}, E.J.M. and {van der Geest}, L.G. and {de Groot}, D.J.A. and {de Groot}, J.W.B. and N.H. Mohammad and B.C.M. Haberkorn and J.T. Haver and {van der Harst}, E. and G.J.M. Hemmink and {de Hingh}, I.H. and C. Hoge and M.Y.V. Homs and {van Huijgevoort}, N.C. and M.A.J.M. Jacobs and E.D. Kerver and M.S.L. Liem and M. Los and H. Lubbinge and S.A.C. Luelmo and {de Meijer}, V.E. and L. Mekenkamp and I.Q. Molenaar and {van Oijen}, M.G.H. and G.A. Patijn and R. Quispel and {van Rijssen}, L.B. and T.E.H. Romkens and {van Santvoort}, H.C. and J.M.J. Schreinemakers and H. Schut and T. Seerden and M.W.J. Stommel and {ten Tije}, A.J. and N.G. Venneman and {Dutch Pancreatic Canc Grp} and {de Vos-Geelen}, J.M.P.G.M. and M.G. Besselink",

note = "Publisher Copyright: {\textcopyright} 2020 The Author(s).",

year = "2020",

month = apr,

day = "16",

doi = "10.1186/s13063-020-4180-z",

language = "English",

volume = "21",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

}

Mackay, TM, Smits, FJ, Latenstein, AEJ, Bogte, A, Bonsing, BA, Bos, H, Bosscha, K, Brosens, LAA, Hol, L, Busch, ORC, Creemers, GJ, Curvers, WL, den Dulk, M, van Dieren, S, van Driel, LMJW, Festen, S, van Geenen, EJM, van der Geest, LG, de Groot, DJA, de Groot, JWB, Mohammad, NH, Haberkorn, BCM, Haver, JT, van der Harst, E, Hemmink, GJM, de Hingh, IH, Hoge, C, Homs, MYV, van Huijgevoort, NC, Jacobs, MAJM, Kerver, ED, Liem, MSL, Los, M, Lubbinge, H, Luelmo, SAC, de Meijer, VE, Mekenkamp, L, Molenaar, IQ, van Oijen, MGH, Patijn, GA, Quispel, R, van Rijssen, LB, Romkens, TEH, van Santvoort, HC, Schreinemakers, JMJ, Schut, H, Seerden, T, Stommel, MWJ, ten Tije, AJ, Venneman, NG, Dutch Pancreatic Canc Grp, de Vos-Geelen, JMPGM & Besselink, MG 2020, 'Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial', Trials, vol. 21, no. 1, 334. https://doi.org/10.1186/s13063-020-4180-z

TY - JOUR

T1 - Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial

AU - Mackay, T.M.

AU - Smits, F.J.

AU - Latenstein, A.E.J.

AU - Bogte, A.

AU - Bonsing, B.A.

AU - Bos, H.

AU - Bosscha, K.

AU - Brosens, L.A.A.

AU - Hol, L.

AU - Busch, O.R.C.

AU - Creemers, G.J.

AU - Curvers, W.L.

AU - den Dulk, M.

AU - van Dieren, S.

AU - van Driel, L.M.J.W.

AU - Festen, S.

AU - van Geenen, E.J.M.

AU - van der Geest, L.G.

AU - de Groot, D.J.A.

AU - de Groot, J.W.B.

AU - Mohammad, N.H.

AU - Haberkorn, B.C.M.

AU - Haver, J.T.

AU - van der Harst, E.

AU - Hemmink, G.J.M.

AU - de Hingh, I.H.

AU - Hoge, C.

AU - Homs, M.Y.V.

AU - van Huijgevoort, N.C.

AU - Jacobs, M.A.J.M.

AU - Kerver, E.D.

AU - Liem, M.S.L.

AU - Los, M.

AU - Lubbinge, H.

AU - Luelmo, S.A.C.

AU - de Meijer, V.E.

AU - Mekenkamp, L.

AU - Molenaar, I.Q.

AU - van Oijen, M.G.H.

AU - Patijn, G.A.

AU - Quispel, R.

AU - van Rijssen, L.B.

AU - Romkens, T.E.H.

AU - van Santvoort, H.C.

AU - Schreinemakers, J.M.J.

AU - Schut, H.

AU - Seerden, T.

AU - Stommel, M.W.J.

AU - ten Tije, A.J.

AU - Venneman, N.G.

AU - Dutch Pancreatic Canc Grp

AU - de Vos-Geelen, J.M.P.G.M.

AU - Besselink, M.G.

PY - 2020/4/16

Y1 - 2020/4/16

N2 - BackgroundPancreatic 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/designPACAP-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.

AB - BackgroundPancreatic 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/designPACAP-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.

KW - best practices

KW - biliary drainage

KW - chemotherapy

KW - design

KW - guidelines

KW - implementation

KW - pancreatic cancer

KW - pancreatic enzyme replacement therapy

KW - quality of life

KW - registry

KW - resection

KW - sample-size

KW - statement

KW - stepped-wedge cluster randomized controlled trial

KW - survival

U2 - 10.1186/s13063-020-4180-z

DO - 10.1186/s13063-020-4180-z

M3 - Article

C2 - 32299515

SN - 1745-6215

VL - 21

JO - Trials

JF - Trials

IS - 1

M1 - 334

ER -

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

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Keywords

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