Dataset Information

Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial.

ABSTRACT:

Introduction

Patients with cancer often receive care that is not aligned with their personal values and goals. Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values.

Methods and analysis

In this study, we describe the design of a stepped-wedge cluster randomized trial to evaluate the impact of an intervention that employs machine learning-based prognostic algorithms and behavioral nudges to prompt oncologists to have SICs with patients at high risk of short-term mortality. Data are collected on documented SICs, documented advance care planning discussions, and end-of-life care utilization (emergency room and inpatient admissions, chemotherapy and hospice utilization) for patients of all enrolled clinicians.

Conclusion

This trial represents a novel application of machine-generated mortality predictions combined with behavioral nudges in the routine care of outpatients with cancer. Findings from the trial may inform strategies to encourage early serious illness conversations and the application of mortality risk predictions in clinical settings.

Trial registration

Clinicaltrials.gov Identifier: NCT03984773.

SUBMITTER: Manz CR

PROVIDER: S-EPMC7910008 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial.

Manz Christopher R CR Parikh Ravi B RB Evans Chalanda N CN Chivers Corey C Regli Susan H SH Bekelman Justin E JE Small Dylan D Rareshide Charles A L CAL O'Connor Nina N Schuchter Lynn M LM Shulman Lawrence N LN Patel Mitesh S MS

Contemporary clinical trials 20200123

<h4>Introduction</h4>Patients with cancer often receive care that is not aligned with their personal values and goals. Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values.<h4>Methods and analysis</h4>In this study, we describe the design of a stepped-wedge cluster randomized trial to evaluate the impact of an intervention that employs machine learning-based prognostic algorithms and behavioral nudge ...[more]

PMID: 31982648

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Project description:Importance:Serious illness conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Interventions that increase the rate of SICs between oncology clinicians and patients may improve goal-concordant care and patient outcomes. Objective:To determine the effect of a clinician-directed intervention integrating machine learning mortality predictions with behavioral nudges on motivating clinician-patient SICs. Design, Setting, and Participants:This stepped-wedge cluster randomized clinical trial was conducted across 20 weeks (from June 17 to November 1, 2019) at 9 medical oncology clinics (8 subspecialty oncology and 1 general oncology clinics) within a large academic health system in Pennsylvania. Clinicians at the 2 smallest subspecialty clinics were grouped together, resulting in 8 clinic groups randomly assigned to the 4 intervention wedge periods. Included participants in the intention-to-treat analyses were 78 oncology clinicians who received SIC training and their patients (N?=?14?607) who had an outpatient oncology encounter during the study period. Interventions:(1) Weekly emails to oncology clinicians with SIC performance feedback and peer comparisons; (2) a list of up to 6 high-risk patients (?10% predicted risk of 180-day mortality) scheduled for the next week, estimated using a validated machine learning algorithm; and (3) opt-out text message prompts to clinicians on the patient's appointment day to consider an SIC. Clinicians in the control group received usual care consisting of weekly emails with cumulative SIC performance. Main Outcomes and Measures:Percentage of patient encounters with an SIC in the intervention group vs the usual care (control) group. Results:The sample consisted of 78 clinicians and 14?607 patients. The mean (SD) age of patients was 61.9 (14.2) years, 53.7% were female, and 70.4% were White. For all encounters, SICs were conducted among 1.3% in the control group and 4.6% in the intervention group, a significant difference (adjusted difference in percentage points, 3.3; 95% CI, 2.3-4.5; P?<?.001). Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P?<?.001). Conclusions and Relevance:In this stepped-wedge cluster randomized clinical trial, an intervention that delivered machine learning mortality predictions with behavioral nudges to oncology clinicians significantly increased the rate of SICs among all patients and among patients with high mortality risk who were targeted by the intervention. Behavioral nudges combined with machine learning mortality predictions can positively influence clinician behavior and may be applied more broadly to improve care near the end of life. Trial Registration:ClinicalTrials.gov Identifier: NCT03984773.

Project description:BackgroundSelf-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning.MethodsThis is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6?months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery.DiscussionNECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice.Trial registrationClinicalTrials.gov NCT03972735 . Trial registration date 31 May 2019.

Project description:Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness.We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months.Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events.A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).

Project description:BackgroundAdvance care planning (ACP) conversations are associated with improved end-of-life healthcare outcomes and patients want to engage in ACP with their healthcare providers. Despite this, ACP conversations rarely occur in primary care settings. The objective of this study was to implement ACP through adapted Serious Illness Care Program (SICP) training sessions, and to understand primary care provider (PCP) perceptions of implementing ACP into practice.MethodsWe conducted a quality improvement project guided by the Normalization Process Theory (NPT), in an interprofessional academic family medicine group in Hamilton, Ontario, Canada. NPT is an explanatory model that delineates the processes by which organizations implement and integrate new work. PCPs (physicians, family medicine residents, and allied health care providers), completed pre- and post-SICP self-assessments evaluating training effectiveness, a survey evaluating program implementability and sustainability, and semi-structured qualitative interviews to elaborate on barriers, facilitators, and suggestions for successful implementation. Descriptive statistics and pre-post differences (Wilcoxon Sign-Rank test) were used to analyze surveys and thematic analysis was used to analyze qualitative interviews.Results30 PCPs participated in SICP training and completed self-assessments, 14 completed NoMAD surveys, and 7 were interviewed. There were reported improvements in ACP confidence and skills. NoMAD surveys reported mixed opinions towards ACP implementation, specifically concerning colleagues' abilities to conduct ACP and patients' abilities to participate in ACP. Physicians discussed busy clinical schedules, lack of patient preparedness, and continued discomfort or lack of confidence in having ACP conversations. Allied health professionals discussed difficulty sharing patient prognosis and identification of appropriate patients as barriers.ConclusionsTraining in ACP conversations improved PCPs' individual perceived abilities, but discomfort and other barriers were identified. Future iterations will require a more systematic process to support the implementation of ACP into regular practice, in addition to addressing knowledge and skill gaps.

Project description:IntroductionFewer than half of all people in the USA have a documented advance care plan (ACP). Hospitalisation offers an opportunity for physicians to initiate ACP conversations. Despite expert recommendations, hospital-based physicians (hospitalists) do not routinely engage in these conversations, reserving them for the critically ill.The objective of this study is to test the effect of a novel behavioural intervention on the incidence of ACP conversations by hospitalists practicing at a stratified random sample of hospitals drawn from 220 US acute care hospitals staffed by a large, nationwide acute care physician practice with an ongoing ACP quality improvement initiative.Methods and analysisWe developed Hopewell Hospitalist, a theory-based adventure video game, to modify physicians' attitudes towards ACP conversations and to increase their motivation for engaging in them. The planned study is a pragmatic stepped-wedge crossover phase III trial, testing the efficacy of Hopewell Hospitalist for increasing ACP conversations. We will randomise 40 hospitals to the month (step) in which they receive the intervention. We aim to recruit 30 hospitalists from up to eight hospitals each step to complete the intervention, playing Hopewell Hospitalist for at least 2 hours. The primary outcome is ACP billing for patients aged 65 and older managed by participating hospitalists. We hypothesise that the intervention will increase ACP billing in the quarter after dissemination, and have 80% power to detect a 1% absolute increase and 99% power to detect a 3.5% absolute increase.Ethics and disseminationDartmouth's Committee for the Protection of Human Subjects has approved the study protocol, which is registered on clinicaltrials.gov. We will disseminate the results through manuscripts and the trials website. Hopewell Hospitalist will be made available on the iOS Application Store for download, free of cost, at the conclusion of the trial.Trial registration numberNCT04557930.

Project description:BackgroundSerious illness conversations may lead to care consistent with patients' goals near the end of life. The emergency department could serve as an important time and location for these conversations.AimTo determine the feasibility of an emergency department-based, brief motivational interview to stimulate serious illness conversations among seriously ill older adults by trained nurses.DesignA pre-/post-intervention study.Settings/participantsIn an urban, tertiary care, academic medical center and a community hospital from January 2021 to January 2022, we prospectively enrolled adults ⩾50 years of age with serious illness and an expected prognosis <1 year. We measured feasibility outcomes using the standardized framework for feasibility studies. In addition, we also collected the validated 4-item Advance Care Planning Engagement Survey (a 5-point Likert scale) at baseline and 4-week follow-up and reviewing the electronic medical record for documentation related to newly completed serious illness conversations.ResultsAmong 116 eligible patients who were willing and able to participate, 76 enrolled (65% recruitment rate), and 68 completed the follow-up (91% retention rate). Mean patient age was 64.4 years (SD 8.4), 49% were female, and 58% had metastatic cancer. In all, 16 nurses conducted the intervention, and all participants completed the intervention with a median duration of 27 min. Self-reported Advance Care Planning Engagement increased from 2.78 pre to 3.31 post intervention (readiness to "talk to doctors about end-of-life wishes," p < 0.008). Documentation of health care proxy forms increased (62-70%) as did Medical Order for Life Sustaining Treatment (1-11%) during the 6 months after the emergency department visit.ConclusionA novel, emergency department-based, nurse-led brief motivational interview to stimulate serious illness conversations is feasible and may improve advance care planning engagement and documentation in seriously ill older adults.

Dataset Information

Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial.

Introduction

Methods and analysis

Conclusion

Trial registration

Publications

Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial.

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