CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,450 enrolled
Drug / intervention
Usual Care +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04867850
NCT04867850N/ACompleted

Effect of Behavioral Nudges to Clinicians, Patients, or Both on Serious Illness Conversation Documentation for Patients With Cancer

Abramson Cancer Center at Penn Medicine·interventional·Posted Apr 30, 2021·Updated Apr 18, 2024

In Brief

A clinical study evaluating Usual Care, Clinician Nudge, and 1 other intervention for Cancer. Completed, enrolled 4,450 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 30, 2021
Enrollment StartSep 9, 2021
Primary CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 5.2 years ago

Interventions

Usual Careother

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.

Clinician Nudgeother

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.

Patient Nudgeother

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.