Background:Postoperative complications and readmissions to hospital are factors known to negatively influence the short- and long-term quality of life of patients with gastrointestinal cancer. Active family involvement in activities, such as fundamental care activities, has the potential to improve the quality of health care. However, there is a lack of evidence regarding the relationship between active family involvement and outcomes in patients with gastrointestinal cancer after surgery.Objective:This protocol aims to evaluate the effect of a family involvement program (FIP) on unplanned readmissions of adult patients undergoing surgery for malignant gastrointestinal tumors. Furthermore, the study aims to evaluate the effect of the FIP on family caregiver (FC) burden and their well-being and the fidelity of the FIP.Methods:This cohort study will be conducted in 2 academic hospitals in the Netherlands. The FIP will be offered to adult patients and their FCs. Patients are scheduled for oncological gastrointestinal surgery and have an expected hospital stay of at least 5 days after surgery. FCs must be willing to participate in fundamental care activities during hospitalization and after discharge. Consenting patients and their families will choose to either participate in the FIP or be included in the usual care group. According to the power calculation, we will recruit 150 patients and families in the FIP group and 150 in the usual care group. The intervention group will receive the FIP that consists of information, shared goal setting, task-oriented training, participation in fundamental care, presence of FCs during ward rounds, and rooming-in for at least 8 hours a day. Patients in the comparison group will receive usual postoperative care. The primary outcome measure is the number of unplanned readmissions up to 30 days after surgery. Several secondary outcomes will be collected, that is, total number of complications (sensitive to fundamental care activities) at 30 and 90 days after surgery, emergency department visits, intensive care unit admissions up to 30 and 90 days after surgery, hospital length of stay, patients’ quality of life, and the amount of home care needed after discharge. FC outcomes are caregiver burden and well-being up to 90 days after participating in the FIP. To evaluate fidelity, we will check whether the FIP is executed as intended. Univariable regression and multivariable regression analyses will be conducted.Results:The first participant was enrolled in April 2019. The follow-up period of the last participant ended in May 2022. The study was funded by an unrestricted grant of the University hospital in 2018. We aim to publish the results in 2023.Conclusions:This study will provide evidence on outcomes from a FIP and will provide health care professionals practical tools for family involvement in the oncological surgical care setting.
Background: Optimizing transitional care by practicing family-centered care might reduce unplanned events for patients who undergo major abdominal cancer surgery. However, it remains unknown whether involving family caregivers in patients’ healthcare also has negative consequences for patient safety. This study assessed the safety of family involvement in patients’ healthcare by examining the cause of unplanned events in patients who participated in a family involvement program (FIP) after major abdominal cancer surgery. Methods: This is a secondary analysis focusing on the intervention group of a prospective cohort study conducted in the Netherlands. Data were collected from April 2019 to May 2022. Participants in the intervention group were patients who engaged in a FIP. Unplanned events were analyzed, and root causes were identified using the medical version of a prevention- and recovery-information system for monitoring and analysis (PRISMA) that analyses unintended events in healthcare. Unplanned events were compared between patients who received care from family caregivers and patients who received professional at-home care after discharge. A Mann-Whitney U test was used to analyze data. Results: Of the 152 FIP participants, 68 experienced an unplanned event and were included. 112 unplanned events occurred with 145 root causes since some unplanned events had several root causes. Most root causes of unplanned events were patient-related factors (n = 109, 75%), such as patient characteristics and disease-related factors. No root causes due to inadequate healthcare from the family caregiver were identified. Unplanned events did not differ statistically (interquartile range 1–2) (p = 0.35) between patients who received care from trained family caregivers and those who received professional at-home care after discharge. Conclusion: Based on the insights from the root-cause analysis in this prospective multicenter study, it appears that unplanned emergency room visits and hospital readmissions are not related to the active involvement of family caregivers in surgical follow-up care. Moreover, surgical follow-up care by trained family caregivers during hospitalization was not associated with increased rates of unplanned adverse events. Hence, the concept of active family involvement by proficiently trained family caregivers in postoperative care appears safe and feasible for patients undergoing major abdominal surgery.
Background: Multimodal prehabilitation programs are effective at reducing complications after colorectal surgery in patients with a high risk of postoperative complications due to low aerobic capacity and/or malnutrition. However, high implementation fidelity is needed to achieve these effects in real-life practice. This study aimed to investigate the implementation fidelity of an evidence-based prehabilitation program in the real-life context of a Dutch regional hospital.Methods: In this observational cohort study with multiple case analyses, all patients who underwent colorectal surgery from January 2023 to June 2023 were enrolled. Patients meeting the criteria for low aerobic capacity or malnutrition were advised to participate in a prehabilitation program. According to recent scientific insights and the local care context, this program consisted of four exercise modalities and three nutrition modalities. Implementation fidelity was investigated by evaluating: (1) coverage (participation rate), (2) duration (number of days between the start of prehabilitation and surgery), (3) content (delivery of prescribed intervention modalities), and (4) frequency (attendance of sessions and compliance with prescribed parameters). An aggregated percentage of content and frequency was calculated to determine overall adherence.Results: Fifty-eight patients intended to follow the prehabilitation care pathway, of which 41 performed a preoperative risk assessment (coverage 80%). Ten patients (24%) were identified as high-risk and participated in the prehabilitation program (duration of 33-84 days). Adherence was high (84-100%) in five and moderate (72-73%) in two patients. Adherence was remarkably low (25%, 53%, 54%) in three patients who struggled to execute the prehabilitation program due to multiple physical and cognitive impairments.Conclusion: Implementation fidelity of an evidence-based multimodal prehabilitation program for high-risk patients preparing for colorectal surgery in real-life practice was moderate because adherence was high for most patients, but low for some patients. Patients with low adherence had multiple impairments, with consequences for their preparation for surgery. For healthcare professionals, it is recommended to pay attention to high-risk patients with multiple impairments and further personalize the prehabilitation program. More knowledge about identifying and treating high-risk patients is needed to provide evidence-based recommendations and to obtain higher effectiveness.
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