Effect of Behavioral Nudges on Serious Illness Conversation Documentation

NCT04867850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4450

Last updated 2024-04-18

Study results available
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Summary

The main purpose of this research study is to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing Serious Illness Conversation (SIC) documentation; and to identify moderators of implementation effects on SIC documentation. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms.

The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing the frequency and timeliness of SIC documentation in cancer patients vs. usual care (UC). The investigators hypothesize that each of the implementation strategy arms will significantly increase SIC documentation compared to UC and that the combination of nudges to clinicians and to patients will be the most effective.

Conditions

Interventions

OTHER

Usual Care

Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.

OTHER

Clinician Nudge

Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.

OTHER

Patient Nudge

Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Samuel Takvorian, MD · University of Pennsylvania

  • Ravi Parikh, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2022-09-09
Completion
2022-09-09

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867850 on ClinicalTrials.gov