Dataset Information

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial.

ABSTRACT:

Importance

Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal.

Objective

To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival.

Design, setting, and participants

This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients).

Intervention

The 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care.

Main outcomes and measures

The primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score).

Results

Overall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, -1.09, 95% CI, -3.05 to 0.94).

Conclusions and relevance

In this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options.

Trial registration

ClinicalTrials.gov Identifier: NCT03513705.

SUBMITTER: Mackay TM

PROVIDER: S-EPMC10867778 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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Publications

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial.

Mackay Tara M TM Latenstein Anouk E J AEJ Augustinus Simone S van der Geest Lydia G LG Bogte Auke A Bonsing Bert A BA Cirkel Geert A GA Hol Lieke L Busch Olivier R OR den Dulk Marcel M van Driel Lydi M J W LMJW Festen Sebastiaan S de Groot Derk-Jan A DA de Groot Jan-Willem B JB Groot Koerkamp Bas B Haj Mohammad Nadia N Haver Joyce T JT van der Harst Erwin E de Hingh Ignace H IH Homs Marjolein Y V MYV Los Maartje M Luelmo Saskia A C SAC de Meijer Vincent E VE Mekenkamp Leonie L Molenaar I Quintus IQ Patijn Gijs A GA Quispel Rutger R Römkens Tessa E H TEH van Santvoort Hjalmar C HC Stommel Martijn W J MWJ Venneman Niels G NG Verdonk Robert C RC van Vilsteren Frederike G I FGI de Vos-Geelen Judith J van Werkhoven C Henri CH van Hooft Jeanin E JE van Eijck Casper H J CHJ Wilmink Johanna W JW van Laarhoven Hanneke W M HWM Besselink Marc G MG

JAMA surgery 20240401 4

<h4>Importance</h4>Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal.<h4>Objective</h4>To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival.<h4>Design, setting, and participants</h4>This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with al ...[more]

PMID: 38353966

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Project description:BackgroundAsthma is a prevalent chronic disease that is difficult to manage and associated with marked disparities in outcomes. One promising approach to addressing disparities is shared decision making (SDM), a method by which the patient and provider cooperatively make a decision about asthma care. SDM is associated with improved outcomes for patients; however, time constraints and staff availability are noted implementation barriers. Use of health information technology (IT) solutions may facilitate the utilization of SDM. Coach McLungsSM is a collaborative web-based application that involves pediatric patients, their caregivers, and providers in a personalized experience while gathering patient-reported data. Background logic provides decision support so both audiences can develop a well-informed treatment plan together. The goal of this study is to evaluate the implementation of the Coach McLungsSM intervention into primary care.MethodsImplementation will be evaluated using a stepped wedge randomized control study design at 21 pediatric and family medicine practices within a large, integrated, nonprofit healthcare system. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. We will use a generalized linear mixed models with logit link to test the hypothesis for the reduction in exacerbation rates specifying the fixed effects of intervention and time and random effects for practice and practice*time. This design achieves 84% power to detect the hypothesized effect size difference of 10% in overall exacerbation between control (40%) and intervention (30%) periods (two-sided, p = 0.05). Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the CFIR (Consolidated Framework for Implementation Research) and RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance).DiscussionWe anticipate that a tailored implementation of Coach McLungsSM across diverse primary care practices will lead to a decrease in emergency department visits, hospitalizations, and oral steroid use for patients in the intervention group as compared to the control condition.Trial registrationClincaltrials.gov, NCT05059210. Registered 28 September 2021, https://www.Clinicaltrialsgov/ct2/show/NCT05059210.

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Dataset Information

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Intervention

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial.

Similar Datasets

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