Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial.

Importance: Mailing fecal immunochemical test (FIT) kits to patients' homes has been shown to boost colorectal cancer screening rates, but response rates remain limited, and organized programs typically require repeated outreach attempts. Behavioral economics has shown that offering salient financial incentives to patients may increase participation in preventive health. Objective: To compare the impact of different financial incentives for mailed FIT outreach. Design, Setting, and Participants: This 4-parallel-arm randomized clinical trial included patients aged 50 to 75 years who had an established primary care clinician, at least 2 visits in the prior 2 years, and were eligible for colorectal cancer screening and not up-to-date. This study was conducted at urban primary care practices at an academic health system from December 2015 to February 2018. Data analysis was conducted from March 2018 to September 2018. Interventions: Eligible patients received a letter from their primary care clinician that included a mailed FIT kit and instructions for use. They were randomized in a 1:1:1:1 ratio to receive (1) no financial incentive; (2) an unconditional $10 incentive included with the mailing; (3) a $10 incentive conditional on FIT completion; or (4) a conditional lottery with a 1-in-10 chance of winning $100 after FIT completion. Main Outcomes and Measures: Fecal immunochemical test completion within 2 and 6 months of initial outreach. Results: A total of 897 participants were randomized, with a median age of 57 years (interquartile range, 52-62 years); 56% were women, and 69% were black. The overall completion rate across all arms was 23.5% at 2 months. The completion rate at 2 months was 26.0% (95% CI, 20.4%-32.3%) in the no incentive arm, 27.2% (95% CI, 21.5%-33.6%) in the unconditional incentive arm, 23.2% (95% CI, 17.9%-29.3%) in the conditional incentive arm, and 17.7% (95% CI, 13.0%-23.3%) in the lottery incentive arm. None of the arms with an incentive were statistically superior to the arm without incentive. The overall FIT completion rate across all arms was 28.9% at 6 months, and there was also no difference by arm. The completion rate at 6 months was 32.7% (95% CI, 26.6%-39.3%) in the no incentive arm, 31.7% (95% CI, 25.7%-38.2%) in the unconditional incentive arm, 26.8% (95% CI, 21.1%-33.1%) in the conditional incentive arm, and 24.3% (95% CI, 18.9%-30.5%) in the lottery incentive arm. Conclusions and Relevance: Mailed FIT resulted in high colorectal cancer screening response rates in this population, but different forms of financial incentives of the same expected value ($10) did not incrementally increase FIT completion rates. The incentive value may have been too small or financial incentives may not be effective in this context. Trial Registration: ClinicalTrials.gov Identifier: NCT02594150.

Intuitive vs Deliberative Approaches to Making Decisions About Life Support: A Randomized Clinical Trial.

Importance: Patients with serious illnesses are often encouraged to actively deliberate about the desirability of life support. Yet it is unknown whether deliberation changes the substance or quality of such decisions. Objective: To identify differences in decisions about life support interventions and goals of care made intuitively vs deliberatively by patients with serious illnesses. Design, Setting, and Participants: Randomized clinical trial in which patients were asked to express treatment preferences in a series of clinical scenarios. Participants were 199 hospitalized patients aged 60 years and older with serious oncologic, cardiac, and pulmonary illnesses treated in a large, urban academic hospital from July 1, 2015, through March 15, 2016. Interventions: Patients in the intuitive group were subjected to a cognitive load and instructed to answer each question immediately based on gut instinct. Patients in the deliberative group were not cognitively loaded, were instructed to think carefully about their answers, and were required to explain their answers. Main Outcomes and Measures: Choices regarding life support (4 scenarios) and goals of care (1 scenario), concordance of these choices with patients' valuations of health states that could follow from them, and decisional uncertainty. Results: Of 199 patients, 132 (66%) were male and the mean (SD) age was 67.2 (5.0) years. Similar proportions of patients in the intuitive group (n = 97) and the deliberative group (n = 102) said they would accept a feeding tube for chronic aspiration (42% vs 44%, respectively; difference, -2%; 95% CI, -16% to 12%; P = .79), antibiotics for life-threatening infection in the event of terminal illness (39% vs 43%, respectively; difference, -4%; 95% CI, -18% to 10%; P = .57), a trial of mechanical ventilation (59% vs 60%, respectively; difference,-1%; 95% CI, -15% to 13%; P = .88), and a tracheostomy tube (37% vs 41%, respectively; difference, -4%; 95% CI, -22% to 13%; P = .64). Patients in the deliberative group were slightly more likely than patients in the intuitive group to choose a palliative approach to treatment in the event of serious illness (45% vs 30%, respectively; difference, 15%; 95% CI, 1%-29%; P = .04). Across scenarios, decisional uncertainty was similar between the 2 groups (all P > .05), and intuitive decisions were either equally or more closely aligned with patients' health state valuations than deliberative decisions. Conclusions and Relevance: In this study, encouraging hospitalized patients with serious illnesses to deliberate on end-of-life decisions did not change the content or improve the quality of these decisions. It is important to evaluate whether decision aids and structured communication interventions improve seriously ill patients' choices. Trial Registration: ClinicalTrials.gov Identifier: NCT02487810.

Timely follow-up of positive cancer screening results: A systematic review and recommendations from the PROSPR Consortium.

Timely follow-up for positive cancer screening results remains suboptimal, and the evidence base to inform decisions on optimizing the timeliness of diagnostic testing is unclear. This systematic review evaluated published studies regarding time to follow-up after a positive screening for breast, cervical, colorectal, and lung cancers. The quality of available evidence was very low or low across cancers, with potential attenuated or reversed associations from confounding by indication in most studies. Overall, evidence suggested that the risk for poorer cancer outcomes rises with longer wait times that vary within and across cancer types, which supports performing diagnostic testing as soon as feasible after the positive result, but evidence for specific time targets is limited. Within these limitations, we provide our opinion on cancer-specific recommendations for times to follow-up and how existing guidelines relate to the current evidence. Thresholds set should consider patient worry, potential for loss to follow-up with prolonged wait times, and available resources. Research is needed to better guide the timeliness of diagnostic follow-up, including considerations for patient preferences and existing barriers, while addressing methodological weaknesses. Research is also needed to identify effective interventions for reducing wait times for diagnostic testing, particularly in underserved or low-resource settings. CA Cancer J Clin 2018;68:199-216. © 2018 American Cancer Society.

Six-Month Morbidity and Mortality among Intensive Care Unit Patients Receiving Life-Sustaining Therapy. A Prospective Cohort Study.

RATIONALE: Understanding long-term outcomes of critically ill patients may inform shared decision-making in the intensive care unit (ICU). OBJECTIVES: To quantify 6-month functional outcomes of general ICU patients, and develop a multivariable model comprising factors present during the first ICU day to predict which patients will return to their baseline function 6 months later. METHODS: We conducted a prospective cohort study in three medical ICUs and two surgical ICUs in three hospitals. We enrolled patients who spent at least 3 days in the ICU and received mechanical ventilation for more than 48 hours and/or vasoactive infusions for more than 24 hours. RESULTS: We measured 6-month outcomes including survival, return to original place of residence, and physical and cognitive function. Of 303 enrolled patients, 299 (98.7%) had complete follow-up at 6 months. Among the 169 patients (56.5%) who survived to 6 months, 82.8% returned home, 81.9% were able to toilet, 71.3% were able to ambulate 10 stairs, and 62.4% reported normal cognition. Overall, 31.1% of patients returned to their baseline status on these measures. Factors associated with not returning to baseline included higher APACHE III score, being a medical patient, older age, nonwhite race, recent hospitalization, prior transplantation, and a history of cancer or of neurologic or liver disease. A model including only these Day 1 factors had good discrimination (area under receiver operating characteristic curve, 0.778; 95% confidence interval, 0.724-0.832) and calibration (difference between observed and expected P value, 0.36). CONCLUSIONS: Among patients spending at least 3 days in an ICU and requiring even brief periods of life-sustaining therapy, nearly one-half will be dead and less than one-third will have returned to their baseline status at 6 months. Of those who survive, the majority of patients will be back at home at 6 months. Future research is needed to validate this multivariable model, including readily available patient characteristics available on the first ICU day, that seems to identify patients who will return to baseline at 6 months.

Public Opinion Regarding Financial Incentives to Engage in Advance Care Planning and Complete Advance Directives.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) recently instituted physician reimbursements for advance care planning (ACP) discussions with patients. AIM: To measure public support for similar programs. DESIGN: Cross-sectional online and in-person surveys. SETTING/PARTICIPANTS: English-speaking adults recruited at public parks in Philadelphia, Pennsylvania, from July to August 2013 and online through survey sampling international Web-based recruitment platform in July 2015. Participants indicated support for 6 programs designed to increase advance directive (AD) completion or ACP discussion using 5-point Likert scales. Participants also indicated how much money (US$0-US$1000) was appropriate to incentivize such behaviors, compared to smoking cessation or colonoscopy screening. RESULTS: We recruited 883 participants: 503 online and 380 in-person. The status quo of no systematic approach to motivate AD completion was supported by 67.0% of participants (63.9%-70.1%). The most popular programs were paying patients to complete ADs (58.0%; 54.5%-61.2%) and requiring patients to complete ADs or declination forms for health insurance (54.1%; 50.8%-57.4%). Participants more commonly supported paying patients to complete ADs than paying physicians whose patients complete ADs (22.6%; 19.8%-25.4%) or paying physicians who document ACP discussions (19.1%; 16.5%-21.7%; both P < .001). Participants supported smaller payments for AD completion and ACP than for obtaining screening colonoscopies or stopping smoking. CONCLUSIONS: Americans view payments for AD completion or ACP more skeptically than for other health behaviors and prefer that such payments go to patients rather than physicians. The current CMS policy of reimbursing physicians for ACP conversations with patients was the least preferred of the programs evaluated.

Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial.

The substantial nationwide investment in inpatient palliative care services stems from their great promise to improve patient-centered outcomes and reduce costs. However, robust experimental evidence of these benefits is lacking. The Randomized Evaluation of Default Access to Palliative Services (REDAPS) study is a pragmatic, stepped-wedge, cluster randomized trial designed to test the efficacy and costs of specialized palliative care consultative services for hospitalized patients with advanced chronic obstructive pulmonary disease, dementia, or end-stage renal disease, as well as the overall effectiveness of ordering such services by default. Additional aims are to identify the types of services that are most beneficial and the types of patients most likely to benefit, including comparisons between ward and intensive care unit patients. We hypothesize that patient-centered outcomes can be improved without increasing costs by simply changing the default option for palliative care consultation from opt-in to opt-out for patients with life-limiting illnesses. Patients aged 65 years or older are enrolled at 11 hospitals using an integrated electronic health record. As a pragmatic trial designed to enroll between 12,000 and 15,000 patients, eligibility is determined using a validated, electronic health record-based algorithm, and all outcomes are captured via the electronic health record and billing systems data. The time at which each hospital transitions from control, opt-in palliative care consultation to intervention, opt-out consultation is randomly assigned. The primary outcome is a composite measure of in-hospital mortality and length of stay. Secondary outcomes include palliative care process measures and clinical and economic outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT02505035).

Patient Demands and Requests for Cancer Tests and Treatments.

IMPORTANCE: Surveyed physicians tend to place responsibility for high medical costs more on "demanding patients" than themselves. However, there are few data about the frequency of demanding patients, clinical appropriateness of their demands, and clinicians' compliance with them. OBJECTIVE: To assess how frequently patients demand or request medical tests or treatments, what types they demand, the clinical appropriateness of their demands, and how frequently clinicians comply. DESIGN, SETTING, AND PARTICIPANTS: Immediately after visits, clinicians--physicians, fellows, nurse practitioners, and physician assistants--were interviewed about whether the patient made a demand or request and their type and appropriateness. Interviews occurred in oncology outpatient facilities at 3 Philadelphia-area hospitals between October 2013 and June 2014. MAIN OUTCOMES AND MEASURES: The 4 main outcomes were (1) frequency of patient demands for medical tests or treatments, (2) the types of tests or treatments demanded, (3) clinicians' assessment of the clinical appropriateness of the demands, and (4) how frequently clinicians complied. RESULTS: There were 5050 patient-clinician encounters involving 3624 patients and 60 clinicians. Overall, of the 5050 encounters, 440 (8.7%) included a patient demand or request for a medical intervention. Clinicians complied with 365 of the clinically appropriate demands (83.0%). In only 50 of the 440 encounters with demands (11.4%) did the patient demand or request clinically inappropriate interventions. Clinicians complied with 7 of these inappropriate demands or requests (14%). Clinicians complied with inappropriate demands or requests in only 0.14% (7 of 5050) of encounters. Of the 440 patient demands, 216 (49.1%) were for imaging studies; 68 (15.5%) were for palliative treatments, excluding chemotherapy or radiation; and 60 (13.6%) were for laboratory tests. In a multivariable model, having lung/head and neck cancer (odds ratio [OR], 1.74; 95% CI, 1.26-2.41), receiving active treatments (OR, 1.40; 95% CI, 1.11-1.77), and a fair- or poor-quality patient-clinician relationship (OR, 2.82; 95% CI, 1.13-7.07) were associated with patients making demands or requests (all P < .01). CONCLUSIONS AND RELEVANCE: Patient demands occur in 8.7% of patient-clinician encounters in the outpatient oncology setting. Clinicians deem most demands or requests as clinically appropriate. Clinically inappropriate demands occur in 1% of encounters, and clinicians comply with very few. At least in oncology, "demanding patients" seem infrequent and may not account for a significant proportion of costs.

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies.

OBJECTIVE: To quantify the frequency and seriousness of adverse events in non-oncology phase I studies with healthy participants. DESIGN: Meta-analysis of individual, healthy volunteer level data. SETTING: Phase I studies with healthy volunteers conducted between September 2004 and March 2011 at Pfizer's three dedicated phase I testing sites in Belgium, Singapore, and the United States. These included studies in which drug development was terminated. PARTICIPANTS: 11,028 participants who received the study drug in 394 distinct non-oncology phase I studies, which involved 4620 unique individuals. A total of 2460 (53.2%) participants were involved in only one study, whereas others participated in two or more studies. MAIN OUTCOME MEASURES: Adverse events classified as mild, moderate, and severe as well as serious adverse events-defined by the Food and Drug Administration as events that result in death, a life threatening event, admission to hospital, prolongation of existing hospital stay, a persistent or major disability, or a congenital anomaly or birth defect. Pfizer researchers of phase I trials determined adverse events, and serious adverse events were those filed with the FDA. RESULTS: Overall, 4000 (36.3%) participants who received the study drug experienced no adverse events and 7028 (63.7%) experienced 24,643 adverse events. Overall, 84.6% (n=20,840) of adverse events were mild and 1.0% (n=255) were severe. 34 (0.31%) serious adverse events occurred among the 11,028 participants who received the study agent, with no deaths or life threatening events. Of the 34 serious adverse events, 11 were related to the study drug and seven to study procedures, whereas 16 were unrelated to a study drug or procedure, including four that occurred when the participant was receiving a placebo. Overall, 24.1% (n=5947) of adverse events were deemed to be unrelated to the study drug. With a total of 143 (36%) studies involving placebo, 10.3% (n=2528) of all adverse events occurred among participants receiving placebo. The most common adverse events were headache (12.2%, n=3017), drowsiness (9.8%, n=2410), and diarrhea (6.9%, n=1698). Research on drugs for neuropsychiatric indications had the highest frequency of adverse events (3015 per 1000 participants). CONCLUSION: Among 11,028 healthy participants who received study drug in non-oncology phase I studies, the majority (85%) of adverse events were mild. 34 (0.31%) serious adverse events occurred, with no life threatening events or deaths. Half of all adverse events were related to the study drug or to procedures. Extrapolation of these data to other types of phase I studies, especially with biological agents, may not be warranted.

Default options in advance directives influence how patients set goals for end-of-life care.

Although decisions regarding end-of-life care are personal and important, they may be influenced by the ways in which options are presented. To test this hypothesis, we randomly assigned 132 seriously ill patients to complete one of three types of advance directives. Two types had end-of-life care options already checked-a default choice-but one of these favored comfort-oriented care, and the other, life-extending care. The third type was a standard advance directive with no options checked. We found that most patients preferred comfort-oriented care, but the defaults influenced those choices. For example, 77 percent of patients in the comfort-oriented group retained that choice, while 43 percent of those in the life-extending group rejected the default choice and selected comfort-oriented care instead. Among the standard advance directive group, 61 percent of patients selected comfort-oriented care. Our findings suggest that patients may not hold deep-seated preferences regarding end-of-life care. The findings provide motivation for future research examining whether using default options in advance directives may improve important outcomes, including patients' receipt of wanted and unwanted services, resource use, survival, and quality of life.