Determine the optimal set of implementation strategies to introduce ERATS in the Netherlands; evaluate whether high protocol adherence indeed leads to the expected reduction in length of hospital stay, complications, and readmissions, alongside…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>The primary objective of this study is to achieve a 15% improvement in ERATS protocol adherence, increasing from an estimated 65% to over 80%, in relation to the completion of the ERATS implementation trajectory.</p>
Secondary outcome
<p>Secondary objectives include reducing the length of hospital stay by one day (from six to five days), shortening the time to recovery, decreasing complication and readmission rates, lowering mortality rates, and enhancing patient-reported outcomes measured by EORTC QLQ-C30, EORTC QLQ-LC13, and PROMIS-APS.</p>
Background summary
In the Netherlands, more than 2,200 anatomical lung resections are performed annually. However, perioperative care surrounding these surgeries varies significantly, resulting in differences in length of hospital stay (median 4–8 days) and complication rates. An analysis of the Netherlands Comprehensive Cancer Organisation (IKNL) database and the Dutch Lung Cancer Audit-surgery (DLCA-s) database suggests that this variation cannot be attributed to patient or tumor characteristics but is instead associated with differences in perioperative care, including drain management, pain management, patient education, and mobilization. This impression was confirmed by a survey conducted among all Dutch thoracic surgical centers regarding perioperative care for patients undergoing lung resection.
While the goals of high-quality perioperative care (rapid recovery after surgery, no complications, no readmissions, and high patient satisfaction) are widely shared, an integrated perioperative care protocol is currently lacking in the Netherlands. In other surgical fields, Enhanced Recovery After Surgery (ERAS®) programs have led to reductions in hospital length of stay, complications, readmissions, and costs, along with an increase in the perceived quality of care among patients and healthcare providers. The recently published ERAS® Society / European Society of Thoracic Surgeons (ESTS) guideline for lung resection patients provides a framework to achieve these goals by optimizing and standardizing perioperative care for patients undergoing anatomical lung resection.
To achieve this in the Netherlands, an Enhanced Recovery After Thoracic Surgery (ERATS) care protocol has been developed based on the recommendations from the ERAS®/ESTS guideline. This protocol now needs to be implemented and evaluated. Despite the demonstrated substantial variation in clinically relevant outcomes related to differences in perioperative care practices, the adoption and implementation of a multidisciplinary care protocol by healthcare providers in routine practice remain a challenge. This project aims to evaluate both the effectiveness of the ERATS protocol in improving clinical and patient-reported outcomes, as well as the effectiveness of ERATS implementation, specifically focusing on its integration into routine practice outside of a research setting.
Study objective
Determine the optimal set of implementation strategies to introduce ERATS in the Netherlands; evaluate whether high protocol adherence indeed leads to the expected reduction in length of hospital stay, complications, and readmissions, alongside improved quality of life and social participation.
Study design
This will be achieved through a prospective observational study conducted in 10 centers, comparing the extent to which ERATS is adhered to following the implementation of this new standard of care. By relating this adherence to the degree of adherence to the implementation plan, the most effective implementation strategy can be determined. Additionally, clinical and patient-reported outcomes will be compared before and after the implementation of ERATS, using a retrospective cohort from 2018 (just before the publication of the first international guideline in this field) as a reference. These data will primarily consist of information already recorded for national audit purposes and routine documentation in the electronic patient record (EPR). If the standard patient-reported outcome questionnaires are not yet part of routine care in a participating hospital, they will be distributed through the study.
Intervention
Given the observational nature of the study, there is no intervention involved. All patients in a participating center will be treated according to the new ERATS standard care protocol after its implementation, regardless of their participation in the study.
Study burden and risks
No additional burden is expected for participants, except for completing PROMs questionnaires at three time points as part of the study. In some hospitals, these questionnaires are already part of routine care and will not be considered an extra burden for participants. However, in hospitals where PROMs questionnaires are not yet part of routine care, completing them may be viewed as an additional burden. Each completion of the PROMs questionnaires is expected to take approximately 15 minutes.
EM von Meyenfeldt
Albert Schweitzerplaats 25
Dordrecht 3318AT
Netherlands
0786541111
e.m.von.meyenfeldt@asz.nl
EM von Meyenfeldt
Albert Schweitzerplaats 25
Dordrecht 3318AT
Netherlands
0786541111
e.m.von.meyenfeldt@asz.nl
Listed location countries
Age
Inclusion criteria
Patients aged 18 years or older undergoing anatomical lung resection for suspected or confirmed lung cancer were eligible for inclusion. Written informed consent
Exclusion criteria
Not meeting inclusion criterium
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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Research portal | NL-010060 |