Clinical trial NCT05231473: Impact of the Nurse Enhanced Recovery After Surgery Coordinator on the Compliance in Colorectal Surgery (nursERAS-BCN)
Official title: Impact of the Nurse Enhanced Recovery After Surgery Coordinator on the Compliance of Multimodal Rehabilitation Programs in Colorectal Surgery (nursERAS-BCN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ERAS
Enhanced Recovery
Compliance, Treatment
Compliance, Patient
Nurse's Role
Colon Disease
Rectum Disease
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
name: University of Barcelona
First posted: 2022-02-09
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a quasi-experimental study with a control group, an intervention group, without random assignment and multicenter trial; which is carried out at two centers in Barcelona, Spain: Bellvitge University Hospital (BUH) and Hospital Germans Trias i Pujol (HGTiP), between December 2021 and November 2023. The participants are assigned according to the implanted and functioning program of each center, to one of two arms: a control arm, in which they join the ERAS program without NEC (group I), and an intervention arm, in which the participants will be included in the ERAS program with NEC (group II).

In HGTiP, the ERAS program without NEC is carried out in a standardized way, and in BUH it is carried out with NEC for all patients. The study directly compares both programs and their compliance in patients who are candidates for elective colorectal surgery.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose. The aim of this study is to evaluate the impact of the implementation of the Nurse Enhanced Recovery After Surgery Coordinator (NEC), within the Enhanced Recovery After Surgery (ERAS) program, in relation to the compliance of patients undergoing colorectal surgery.

Methods. Quasi-experimental study with a control group, an intervention group and without random assignment in a multicenter trial; between December 2021 and November 2023. Patients older than 18 years with planned elective intervention of major colorectal surgery will be included; excluding those without social support, with psychiatric illness, cognitive difficulty, planning of simultaneous or emergency surgery. In the intervention arm they will have NEC and in the control group they will not have that resource. Compliance will be the main variable of the study and, in addition, the study aims to assess secondary endpoints such as quality of life (QOL).

Conclusions. NEC could increase compliance to ERAS programs, improving health outcomes and QOL perceived by the patient. The applicability in the different hospital centers could generate an opportunity to advance professionally in the nursing figure within the ERAS program. The fact of having NEC could also increase the efficiency of the program due to the cost-effectiveness of the nursing position, although this is not the object of the study. It would be applicable in improving perceived health and QOL, so it could also have an economic impact on the health system.

Detailed description: Background. Fast-track Surgery or Enhanced Recovery After Surgery (ERAS), also called multimodal rehabilitation in Spain, constitutes the application of a series of perioperative measures and strategies aimed at those patients who undergo surgery with the objective to reduce surgical stress, promoting a better recovery of the patient by significantly reducing complications and mortality.

The ERAS programs have represented an important change in the surgical field since it opens a new line of action different from the traditional one. These protocols include a set of perioperative measures applied in a multidisciplinary way, whose advantages have been scientifically endorsed. However, these programs still face more traditional attitudes and practices, so their application is still limited today.

The Nurse ERAS Coordinator (NEC) was integrated into the multidisciplinary teams at the same time of implementation of the programs in the northern European countries, betting on their leadership and capacity from the beginning. This figure ensures that the ERAS guidelines advance in the process until their final approval and participate in the fulfillment of the protocol in the different phases. They carry out interventions based on as much evidence as possible and contribute to the collection of data for ongoing audits. In addition, they are characterized by high levels of communication skills, resourcefulness and innovation, these being key attributes of the ERAS coordinator and favoring the participation of the entire multidisciplinary team through organizational change.

Starting in the 1990s, two groups of surgeons presented different measures to improve the postoperative evolution of patients who underwent elective colorectal surgery. Both groups emphasized the importance of the information provided to the patient and its role in postoperative recovery. In Europe, specifically at the Hvidovre University Hospital in Denmark, the first group led by Kehlet emerged, who proposed different strategies to improve the postoperative period of these patients; also acting preoperatively and during surgery. Years later, the second group emerged in the United States, led by Delaney et al. from the Cleveland Clinic, who focused his studies on postoperative improvement based on the advances of the previous group, specifically in the administration of an early diet and the stimulation of early mobilization. In this way, the ERAS programs emerged.

However, it was not until 2001, when the ERAS group was formed, made up of different colorectal surgery units from 5 northern European countries (Scotland, Sweden, Denmark, Norway and the Netherlands). This group agreed on what they would call the ERAS project led by Kehlet. The recommended actions began at the moment of diagnosis and sought to recognize the individual needs of the patient to optimize their treatment before, during and after surgery.

Most of the studies whose objective has been to evaluate the efficacy of the measures that make up the ERAS program, agree that their implementation is beneficial for patients and is directly related to compliance with these measures in each of the perioperative phases.

In this sense, it is essential to consider the following key points of the program, extracted from the consensus of experts and published guides:

1. All patients participating in the protocol must start it preoperatively, which allows them a faster recovery from surgery and postoperative convalescence, minimizing physical and psychological stress.
2. The prior preparation of the patient is essential and ensures that he is in the best possible condition, identifying personal risks in the preoperative.
3. The treatment is comprehensive and includes pre, intra and postoperative measures in which the investigators act actively.
4. Patients have an active role and must take responsibility to improve their recovery.
5. Preoperative or prehabilitation period: to optimize the physical, nutritional, emotional, medical and pharmacological status of the patient; to arrive at surgery in the best possible conditions.
6. Intraoperative period: laparoscopic surgery, fluid restriction, pain control, multimodal analgesia.
7. Postoperative period: ambulation and early intake, antithrombotic measures, respiratory physiotherapy.

The implementation of ERAS programs also contributes to the improvement in the QOL perceived by the patient during the first phases of recovery. Furthermore, as a consequence, it produces a reduced general economic cost due to the decrease in the average stay in most cases.

Despite all the above, there is no evidence available that evaluates the direct impact of the NEC figure, which was implemented in 2001 in Northern Europe, the United States and Canada with a fundamental role. This is the first trial that analyzes the impact on compliance and, therefore, on health and QOL results in patients with colorectal surgery within ERAS programs.

Ethics. The study will be carried out in accordance with the Declaration of Helsinki and the Spanish laws and regulations for biomedical research. The trial protocol and patient information have been approved by the competent Ethics Committees of all participating trial centers. The data collection is part of the usual clinical practice of each participating center. For the present study, the data will be collected from the electronic medical record; therefore, the Research Ethics Committee is requested to exempt the informed consent.

During the trial, the database will not contain any identifying information about the patient. A separate document will contain the relationship of each patient with the assignment of an alphanumeric code, to which only the main researcher of the project will have access. Trials findings will be stored in accordance with Spanish data protection law (Law 15/1999 on the protection of personal data) and will be handled in strictest confidence. For protection of these data, organizational procedures are implemented to prevent distribution of data to unauthorized people.

Management of patients and Follow-up. The program was presented to the Ethics and Research Committees Clinic of both centers to, after approval, be coordinated by the NEC in BUH. NEC will be in charge of informing and training all professionals involved in any service and discipline. She will be responsible for appointing a referral from each specialty, with whom she will communicate constantly and through which all the information will be distributed through the different professionals.

Before starting the program, meetings will be convened with the heads of anesthesiology service, general and digestive surgery and nursing. The purpose of these meetings initially will be to establish synergies and align shared objectives.

Data will be collected by different professionals at each stage, but it will be the NEC who ensures and supervises the correct completion of them throughout the process. In the preadmission stage will be registered by the NEC, as well as in the immediate preoperative stage. To intraoperative level, the responsible anesthesiologist will register it. Finally, the team of surgeons will record the variables in the postoperative period. The measurement of the compliance variable will be based on the indicators of colorectal process: 17 process indicators and 2 result indicators will be evaluated following the ERAS Society audit guidelines.

Regarding the measurement of QOL, a self-administered questionnaire on the first visit of the program by the NEC, re-administering the same at 90 days postoperative: SF-12 to all patients, EORTC QLQ C30 and CR-29 in case of neoplasia.

In HGTiP, the hospital which does not have NEC, it will be the lead surgeon or head of the program who assumes this role in all the stages.

Sample size of the study. The sample size for two independent proportions (compliance), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 103 subjects are necessary in first group and 103 in the second to find as statistically significant a proportion difference, expected to be of 0.5 in intervention group and 0.3 in control group. It has been anticipated a drop-out rate of 10%.

Statistical analysis. Descriptive methods will be used to present the distribution of variables in the study groups, with frequencies and percentages with the corresponding 95% confidence interval (CI) for categorical variables, and mean and standard deviation (SD) or median and interquartile range (25th-75th percentile) for quantitative variables. The chi-square (χ2) test will be used for the comparison of categorical variables. Clinically relevant or statistically significant variables in the bivariate analysis as well as possible confounding variables will be analyzed in a binary logistic regression model. The Mann-Whitney test will be used for the comparison of continuous variables. Also, a longitudinal analysis of variables collected at follow-up (QOL) will be performed. Statistical significance is set at P\< 0.05. All analyses will be done using SPSS program, version 26.0.

Discussion. ERAS programs incorporate a series of evidence-based strategies with the aim of reducing the stress triggered by surgery and increasing functional recovery. This implies a reduction in postoperative complications, hospital stay and generates health savings. Monitoring the degree of compliance with the different strategies is necessary, not only to assess its quality and identify points for improvement, but also because the level of compliance with the program influences the patients' health results.

Despite heterogeneity in coordination and management, ERAS programs are evaluated as successful from a nurse's perspective. Continuous staff education and coordination beyond the implementation period appear to be of the utmost importance for a sustained program and the role of NEC is very important.

The available evidence suggests patients suffer no detriment to satisfaction or QOL with use of ERAS protocols, and may suffer less fatigue and return to activities sooner. The use of ERAS protocols in colorectal surgery achieves a positive influence, not only by decreasing surgical-related complications but also in terms of functional recovery, by decreasing the negative effects of surgery on patient QOL.

The main objective of this study is to demonstrate that the tertiary hospitals that integrate the NEC in the ERAS programs, obtain a higher compliance than the hospitals that do not; improving health outcomes and perceived QOL of elective colorectal surgery patients.

The investigators believe that the NEC can be a key element in the implementation of ERAS programs, commonly coordinated by surgeons and anaesthesiologists, since as described above, they are part of the implementation team and would only require a role of competencies enlarged; having more prominence in the status of projects.

In addition, the investigators consider that having this figure could lead to an improvement in the QOL perceived by the patient within the ERAS programs, due to the monitoring carried out by the ERAS Nurse Coordinator throughout the perioperative process according to the definition of its functions and the possible increase in compliance with the protocol it causes, improving health outcomes.

At the same time, lower secondary morbidity can translate into lower hospital costs (fewer stays and fewer admissions).

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Candidates to elective major colorectal surgery due to benign or malignant pathology

Exclusion Criteria:

* Rejection of the patient to participate in ERAS program
* Inadequate social support that makes it difficult to comply with a discharge planned hospital
* Associated psychiatric illness, mental or organic disorders which could interfere with receiving treatments or indications about the program
* Patients with combined surgeries or simultaneous with other specialties by synchronism.
* Patients with emergency surgery

Primary outcomes:
measure: Relationship between compliance to Enhanced Recovery After Surgery program and Nurse ERAS Coordinator as assessed by ERAS Society Guidelines
timeFrame: 30 days
Secondary outcomes:
measure: Quality of Life undergoing ERAS programs as assessed by SF-12 questionnaire.
timeFrame: 90 days
measure: Quality of Life undergoing ERAS programs as assessed by EORTC QLQ C30 questionnaire.
timeFrame: 90 days
measure: Quality of Life undergoing ERAS programs as assessed by EORTC QLQ CR-29 questionnaire.
timeFrame: 90 days
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Bellvitge University Hospital
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Jose Antonio Jerez-Gonzalez, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: M.Carmen Moreno-Arroyo, PhD
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Miguel Angel Hidalgo-Blanco, PhD
role: STUDY_DIRECTOR
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