Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Importance: Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations. Objective: To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers. Design, Setting, and Participants: From October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients. Intervention: Surgeon-palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network-recommended triggers for palliative care consultation. Main Outcomes and Measures: The primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed. Results: In total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon-palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon-palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], -0.07 [0.87] vs -0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99). Conclusions and Relevance: To date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care-associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers. Trial Registration: ClinicalTrials.gov Identifier: NCT03611309.

Integrating Advance Care Planning Videos into Surgical Oncologic Care: A Randomized Clinical Trial.

Background: Preoperative advance care planning (ACP) may benefit patients undergoing major surgery. Objective: To evaluate feasibility, safety, and early effectiveness of video-based ACP in a surgical population. Design: Randomized controlled trial with two study arms. Setting: Single, academic, inner-city tertiary care hospital. Subjects: Patients undergoing major cancer surgery were recruited from nine surgical clinics. Of 106 consecutive potential participants, 103 were eligible and 92 enrolled. Interventions: In the intervention arm, patients viewed an ACP video developed by patients, surgeons, palliative care clinicians, and other stakeholders. In the control arm, patients viewed an informational video about the hospital's surgical program. Measurements: Primary Outcomes-ACP content and patient-centeredness in patient-surgeon preoperative conversation. Secondary outcomes-patient Hospital Anxiety and Depression Scale (HADS) score; patient goals of care; patient and surgeon satisfaction; video helpfulness; and medical decision maker designation. Results: Ninety-two patients (target enrollment: 90) were enrolled. The ACP video was successfully integrated with no harm noted. Patient-centeredness was unchanged (incidence rate ratio [IRR] = 1.06, confidence interval [0.87-1.3], p = 0.545), although there were more ACP discussions in the intervention arm (23% intervention vs. 10% control, p = 0.18). While slightly underpowered, study results did not signal that further enrollment would have yielded statistical significance. There were no differences in secondary outcomes other than the intervention video was more helpful (p = 0.007). Conclusions: The ACP video was successfully integrated into surgical care without harm and was thought to be helpful, although video content did not significantly change the ACP content or patient-surgeon communication. Future studies could increase the ACP dose through modifying video content and/or who presents ACP. Trial Registration: clinicaltrials.gov Identifier NCT02489799.

Trends in Outcomes After Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy.

BACKGROUND: Hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CRS) have been shown to improve clinical outcomes among select patients presenting with peritoneal carcinomatosis. The aim of the present study was to describe temporal trends in clinical outcomes among patients undergoing CRS/HIPEC. MATERIALS AND METHODS: Patients who underwent CRS/HIPEC were identified using the American College of Surgeons National Surgical Quality Improvement Program databases from 2005 to 2013. A multivariable logistic regression analysis was performed to identify risk factors associated with postoperative morbidity and mortality. RESULTS: A total of 889 patients were identified who met the inclusion criteria. The most common primary tumor sites were the peritoneum (59.8%), followed by the appendix (13.7%) and colon (6.4%). The median operative time for all patients was 438 min (interquartile range: 328-550); postoperative morbidity was 41.3%, and 2.0% of patients died within 30 d of surgery. Over the time evaluated, a statistically significant decrease was observed in the median operative time (2005 versus 2013, 600 versus 403 min), postoperative morbidity (50.0% versus 36.1%), and length of stay (13.5 versus 8 d; all P < 0.05). On multivariable analysis, age > 65 y (odds ratio [OR] = 1.51; 95% confidence interval [CI]: 1.02-2.24; P = 0.037), a low preoperative hematocrit (OR = 1.66; 95% CI: 1.19-2.33; P = 0.003), and preoperative serum albumin < 3 g/dL (OR = 2.10; 95% CI: 1.13-3.90; P = 0.019) were independently associated with greater odds for developing a postoperative complication and/or postoperative death. CONCLUSIONS: Operative time, postoperative morbidity, and length of stay after CRS/HIPEC were observed to improve over the study period. Careful patient selection may result in favorable outcomes for select patients undergoing CRS/HIPEC.

Shared Decision-Making in Acute Surgical Illness: The Surgeon's Perspective.

BACKGROUND: Surgical patients increasingly have more comorbidities and are of an older age, complicating surgical decision-making in emergent situations. Little is known about surgeons' perceptions of shared decision-making in these settings. STUDY DESIGN: Twenty semi-structured interviews were conducted with practicing surgeons at 2 large academic medical centers. Thirteen questions and 2 case vignettes were used to assess perceptions of decision-making, considerations when deciding whether to offer to operate, and communication patterns with patients and families. RESULTS: Thematic analysis revealed 6 major themes: responsibility for the decision to operate, perceived futility, surgeon judgment, surgeon introspection, pressure to operate, and costs of the operation. Perceived futility was universally considered a contraindication to surgical intervention. However, the challenge of defining futility led participants to emphasize the importance of patients' self-determined risk-to-benefit analysis when considering surgical intervention. More experienced surgeons reported greater comfort with communicating to patients that a condition was not amenable to an operation and reserved the right to refuse to operate. CONCLUSIONS: Due to external pressures and uncertainty, some providers err on the side of operative intervention, despite suspected futility. Greater experience allows surgeons to withstand external pressures, be confident in their assessments of perceived futility, and guide patients and their families away from additional interventions.

Developing the Storyline for an Advance Care Planning Video for Surgery Patients: Patient-Centered Outcomes Research Engagement from Stakeholder Summit to State Fair.

BACKGROUND: Patient-centered outcomes research (PCOR) methods and social learning theory (SLT) require intensive interaction between researchers and stakeholders. Advance care planning (ACP) is valuable before major surgery, but a systematic review found no extant perioperative ACP tools. Consequently, PCOR methods and SLT can inform the development of an ACP educational video for patients and families preparing for major surgery. OBJECTIVE: The objective is to develop and test acceptability of an ACP video storyline. DESIGN: The design is a stakeholder-guided development of the ACP video storyline. Design-thinking methods explored and prioritized stakeholder perspectives. Patients and family members evaluated storyboards containing the proposed storyline. SETTING/SUBJECTS: The study was conducted at hospital outpatient surgical clinics, in-person stakeholder summit, and the 2014 Maryland State Fair. MEASUREMENTS: Measurements are done through stakeholder engagement and deidentified survey. RESULTS: Stakeholders evaluated and prioritized evidence from an environmental scan. A surgeon, family member, and palliative care physician team iteratively developed a script featuring 12 core themes and worked with a medical graphic designer to translate the script into storyboards. For 10 days, 359 attendees of the 2014 Maryland State Fair evaluated the storyboards and 87% noted that they would be "very comfortable" or "comfortable" seeing the storyboard before major surgery, 89% considered the storyboards "very helpful" or "helpful," and 89% would "definitely recommend" or "recommend" this story to others preparing for major surgery. CONCLUSIONS: Through an iterative process utilizing diverse PCOR engagement methods and informed by SLT, storyboards were developed for an ACP video. Field testing revealed the storyline to be highly meaningful for surgery patients and family members.

Palliative Care Utilization among Patients Admitted for Gastrointestinal and Thoracic Cancers.

BACKGROUND: Although a growing body of literature recommends the early initiation of palliative care (PC), the use of PC remains variable. OBJECTIVE: The current study sought to describe the use of PC and to identify factors associated with the use of inpatient PC. DESIGN: Retrospective, cross-sectional analysis of data from the National Inpatient Sample. SETTING AND SUBJECTS: Patients admitted with a primary diagnosis of gastrointestinal and/or thoracic cancer from 2012 to 2013. MEASUREMENTS: In-hospital length of stay (LOS), morbidity, mortality, and total charges. RESULTS: A total of 282,899 patients were identified who met inclusion criteria of whom, 24,100 (8.5%) patients received a PC consultation during their inpatient admission. Patients who received PC were more likely to have a longer LOS (LOS >14 days: 5.4% vs. 9.4%) and were more likely to develop a postoperative complication (28.3% vs. 45.9%, both p < 0.001). Inpatient mortality was significantly higher among patients who had received PC than those who did not (5.4% vs. 44.1%, p < 0.001). On multivariable analysis, patient age (age ≥75 years: Odds Ratio [OR] = 2.54, 95% CI: 2.33-2.78), comorbidity (CCI >6: OR = 2.60, 95% CI: 2.48-2.74), and admission to larger hospitals (reference small: OR = 1.20, 95% CI: 1.14-1.25) were associated with greater odds of receiving PC (all p < 0.05). Patients who underwent a major operation during their inpatient admission demonstrated 79% lower odds of receiving PC (OR = 0.21, 95% CI: 0.20-0.22, p < 0.001). CONCLUSIONS: Among patients admitted for cancer, PC services were used in 8.5% of patients during their inpatient admission with surgical patients being 79% less likely to receive a PC consultation. Further research is required to delineate the barriers to the use of PC so as to promote the use of PC among high-risk patients.

Utilising advance care planning videos to empower perioperative cancer patients and families: a study protocol of a randomised controlled trial.

INTRODUCTION: Despite positive health outcomes associated with advance care planning (ACP), little research has investigated the impact of ACP in surgical populations. Our goal is to evaluate how an ACP intervention video impacts the patient centredness and ACP of the patient-surgeon conversation during the presurgical consent visit. We hypothesise that patients who view the intervention will engage in a more patient-centred communication with their surgeons compared with patients who view a control video. METHODS AND ANALYSIS: Randomised controlled superiority trial of an ACP video with two study arms (intervention ACP video and control video) and four visits (baseline, presurgical consent, postoperative 1 week and postoperative 1 month). Surgeons, patients, principal investigator and analysts are blinded to the randomisation assignment. SETTING: Single, academic, inner city and tertiary care hospital. Data collection began July 16, 2015 and continues to March 2017. PARTICIPANTS: Patients recruited from nine surgical oncology clinics who are undergoing major cancer surgery. INTERVENTIONS: In the intervention arm, patients view a patient preparedness video developed through extensive engagement with patients, surgeons and other stakeholders. Patients randomised to the control arm viewed an informational video about the hospital surgical programme. MAIN OUTCOMES AND MEASURES: Primary Outcome: Patient centredness and ACP of patient-surgeon conversations during the presurgical consent visit as measured through the Roter Interaction Analysis System. SECONDARY OUTCOMES: patient Hospital Anxiety and Depression Scale score; patient goals of care; patient, companion and surgeon satisfaction; video helpfulness; medical decision maker designation; and the frequency patients watch the video. Intent-to-treat analysis will be used to assess the impact of video assignment on outcomes. Sensitivity analyses will assess whether there are differential effects contingent on patient or surgeon characteristics. ETHICS AND DISSEMINATION: This study has been approved by the Johns Hopkins School of Medicine institutional review board and is registered on clinicaltrials.gov (NCT02489799, First received: July 1, 2015). TRIAL REGISTRATION NUMBER: clinicaltrials.gov, NCT02489799.