Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Jul 1;7(7):e2418639.
doi: 10.1001/jamanetworkopen.2024.18639.

Clinician- and Patient-Directed Communication Strategies for Patients With Cancer at High Mortality Risk: A Cluster Randomized Trial

Samuel U Takvorian  1 , Peter Gabriel  1 , E Paul Wileyto  1 , Daniel Blumenthal  1 , Sharon Tejada  1 , Alicia B W Clifton  1   2 , David A Asch  1 , Alison M Buttenheim  1   3 , Katharine A Rendle  1 , Rachel C Shelton  4 , Krisda H Chaiyachati  1   5 , Oluwadamilola M Fayanju  1 , Susan Ware  1 , Lynn M Schuchter  1 , Pallavi Kumar  1 , Tasnim Salam  1   6 , Adina Lieberman  1 , Daniel Ragusano  1   7 , Anna-Marika Bauer  1   8 , Callie A Scott  1   9 , Lawrence N Shulman  1 , Robert Schnoll  1 , Rinad S Beidas  10 , Justin E Bekelman  1 , Ravi B Parikh  1
Affiliations
Randomized Controlled Trial

Clinician- and Patient-Directed Communication Strategies for Patients With Cancer at High Mortality Risk: A Cluster Randomized Trial

Samuel U Takvorian et al. JAMA Netw Open. .

Abstract

Importance: Serious illness conversations (SICs) that elicit patients' values, goals, and care preferences reduce anxiety and depression and improve quality of life, but occur infrequently for patients with cancer. Behavioral economic implementation strategies (nudges) directed at clinicians and/or patients may increase SIC completion.

Objective: To test the independent and combined effects of clinician and patient nudges on SIC completion.

Design, setting, and participants: A 2 × 2 factorial, cluster randomized trial was conducted from September 7, 2021, to March 11, 2022, at oncology clinics across 4 hospitals and 6 community sites within a large academic health system in Pennsylvania and New Jersey among 163 medical and gynecologic oncology clinicians and 4450 patients with cancer at high risk of mortality (≥10% risk of 180-day mortality).

Interventions: Clinician clusters and patients were independently randomized to receive usual care vs nudges, resulting in 4 arms: (1) active control, operating for 2 years prior to trial start, consisting of clinician text message reminders to complete SICs for patients at high mortality risk; (2) clinician nudge only, consisting of active control plus weekly peer comparisons of clinician-level SIC completion rates; (3) patient nudge only, consisting of active control plus a preclinic electronic communication designed to prime patients for SICs; and (4) combined clinician and patient nudges.

Main outcomes and measures: The primary outcome was a documented SIC in the electronic health record within 6 months of a participant's first clinic visit after randomization. Analysis was performed on an intent-to-treat basis at the patient level.

Results: The study accrued 4450 patients (median age, 67 years [IQR, 59-75 years]; 2352 women [52.9%]) seen by 163 clinicians, randomized to active control (n = 1004), clinician nudge (n = 1179), patient nudge (n = 997), or combined nudges (n = 1270). Overall patient-level rates of 6-month SIC completion were 11.2% for the active control arm (112 of 1004), 11.5% for the clinician nudge arm (136 of 1179), 11.5% for the patient nudge arm (115 of 997), and 14.1% for the combined nudge arm (179 of 1270). Compared with active control, the combined nudges were associated with an increase in SIC rates (ratio of hazard ratios [rHR], 1.55 [95% CI, 1.00-2.40]; P = .049), whereas the clinician nudge (HR, 0.95 [95% CI, 0.64-1.41; P = .79) and patient nudge (HR, 0.99 [95% CI, 0.73-1.33]; P = .93) were not.

Conclusions and relevance: In this cluster randomized trial, nudges combining clinician peer comparisons with patient priming questionnaires were associated with a marginal increase in documented SICs compared with an active control. Combining clinician- and patient-directed nudges may help to promote SICs in routine cancer care.

Trial registration: ClinicalTrials.gov Identifier: NCT04867850.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Takvorian reported receiving personal fees from Genentech, Astra Zeneca, and Exelixis; and grants from Pfizer outside the submitted work. Dr Wileyto reported receiving grants from the University of Pennsylvania during the conduct of the study. Dr Asch reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study; personal fees from VAL Health, Deloitte, Boehringer Ingelheim, and MARS Veterinary Group outside the submitted work. Dr Buttenheim reported receiving grants from the NIH during the conduct of the study. Dr Rendle reported receiving grants from the NIH/National Cancer Institute paid to institution during the conduct of the study; grants from the NIH/NCI paid to institution, Moore Foundation paid to institution, Pfizer/Lung Cancer Research Foundation paid to institution, and AstraZeneca/National Comprehensive Cancer Network paid to institution; personal fees from Merck; and travel costs and honoraria from MJH outside the submitted work. Dr Chaiyachati reported receiving shares from Verily Life Sciences as a part of employment; personal fees from the Robert Wood Johnson Foundation, the American Board of Internal Medicine, Cambridge University Press, and Intend Health Strategies outside the submitted work. Dr Fayanju reported receiving grants from the NIH and having a collaborative research agreement with Gilead Sciences outside the submitted work. Ms Ware reported receiving grants from the NCI during the conduct of the study. Dr Beidas reported being principal at Implementation Science & Practice LLC; receiving personal fees from OptumLabs and United Behavioral Health; and receiving honoraria from AIM Youth Mental Health Foundation and Klingenstein Third Generation Foundation outside the submitted work. Dr Bekelman reported receiving personal fees from Healthcare Foundry, Reimagine Care, and AstraZeneca; and grants from Lilly@Loxo and Gilead outside the submitted work. Dr Parikh reported stock ownership in Google, GNS Healthcare, Onc.AI, and Thyme Care; serving as a consultant or advisor for ConcertAI, CreditSuisse, Thyme Care, Humana, NanOlogy, and Merck & Co Inc; receiving research funding from Schmidt Futures, Mendel.ai, and Humana; receiving travel expenses from the Oncology Institute of Hope and Innovation; and having intellectual property related to technology to integrate patient-reported outcomes into electronic health record algorithms. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
CONSORT indicates Consolidated Standards of Reporting Trials; SIC, serious illness conversation.
Figure 2.
Figure 2.. Cumulative Incidence of Serious Illness Conversations (SICs) at 6 Months by Study Arm
The Nelson-Aalen estimate shows that an increased probability of a documented SIC was associated with patients receiving the patient nudge and clinicians receiving the clinician nudge.
Figure 3.
Figure 3.. Effect Modification by Patient Subgroups
Hazard ratios (HRs) represent serious illness conversation compared with active control.
See this image and copyright information in PMC

References

    1. Earle CC, Landrum MB, Souza JM, Neville BA, Weeks JC, Ayanian JZ. Aggressiveness of cancer care near the end of life: is it a quality-of-care issue? J Clin Oncol. 2008;26(23):3860-3866. doi:10.1200/JCO.2007.15.8253 - DOI - PMC - PubMed
    1. Emanuel EJ, Young-Xu Y, Levinsky NG, Gazelle G, Saynina O, Ash AS. Chemotherapy use among Medicare beneficiaries at the end of life. Ann Intern Med. 2003;138(8):639-643. doi:10.7326/0003-4819-138-8-200304150-00011 - DOI - PubMed
    1. Wright AA, Keating NL, Ayanian JZ, et al. . Family perspectives on aggressive cancer care near the end of life. JAMA. 2016;315(3):284-292. doi:10.1001/jama.2015.18604 - DOI - PMC - PubMed
    1. Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers’ mental health. J Clin Oncol. 2010;28(29):4457-4464. doi:10.1200/JCO.2009.26.3863 - DOI - PMC - PubMed
    1. Wen FH, Chen JS, Su PJ, et al. . Terminally ill cancer patients’ concordance between preferred life-sustaining treatment states in their last six months of life and received life-sustaining treatment states in their last month: an observational study. J Pain Symptom Manage. 2018;56(4):509-518. doi:10.1016/j.jpainsymman.2018.07.003 - DOI - PubMed

Publication types

Associated data