Effect of Behavioral Nudges on Serious Illness Conversation Documentation

NCT04867850 | Completed Results DMC

• 2 other identifiers: 844816P50CA244690
• Study Type: interventional
• Target: 4,450
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Cancer; Serious Illness Conversation; Machine Learning; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC)

  Measured at the patient level as a binary outcome (yes/no) among high-risk patients based on date of documented note including the SIC template in the Advanced Care Planning (ACP) section of the electronic medical record by any provider Outcomes were measured for patients only.

  Within 6 months of the Index Visit (baseline)

Secondary Outcomes (3)

• Number of Patients With SIC Documentation (Out of All Patients, Regardless of Risk Level)

  Within 6 months of first repeat patient visit during trial period

• Number of High Risk Patients With a Palliative Care Referral

  Within 6 months of the Index Visit (baseline)

• Number of Decedent High Risk Patients Who Received Aggressive End-Of-Life Care

  Within 6 months of the Index Visit (baseline)

Study Arms (4)

Usual Care

ACTIVE COMPARATOR

Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm.

Other: Usual Care

Clinician Nudge

EXPERIMENTAL

Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers.

Other: Clinician Nudge

Patient Nudge

EXPERIMENTAL

Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC.

Other: Patient Nudge

Clinician and Patient Nudge

EXPERIMENTAL

Both strategies described above will be used.

Other: Clinician Nudge; Other: Patient Nudge

Interventions

Usual Care OTHER

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.

Usual Care

Clinician Nudge OTHER

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.

Clinician Nudge; Clinician and Patient Nudge

Patient Nudge OTHER

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.

Clinician and Patient Nudge; Patient Nudge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinician (M.D., P.A., or N.P.) participants must meet the following criteria:
• \. Provide care at least 1 clinic session per week for adult (age\>18 years) patients with solid, hematologic, or gynecologic malignancies at a participating PennMedicine Implementation Lab site
• Patient participants must meet the following criteria:
• Receive care for a solid, hematologic, or gynecologic malignancy from an eligible provider at a participating PennMedicine Implementation Lab site
• Have at least one scheduled Return Patient Visit (either in person or via telemedicine) with an eligible PennMedicine provider during the study period

You may not qualify if:

• Clinicians will be ineligible for \*any\* of the following reasons:
• \. Provide exclusively benign hematology, survivorship, and/or genetics care
• Patients will be ineligible for \*any\* of the following reasons:
• Previously documented SIC within 6 months
• Have a non-valid phone number

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Takvorian SU, Gabriel P, Wileyto EP, Blumenthal D, Tejada S, Clifton ABW, Asch DA, Buttenheim AM, Rendle KA, Shelton RC, Chaiyachati KH, Fayanju OM, Ware S, Schuchter LM, Kumar P, Salam T, Lieberman A, Ragusano D, Bauer AM, Scott CA, Shulman LN, Schnoll R, Beidas RS, Bekelman JE, Parikh RB. Clinician- and Patient-Directed Communication Strategies for Patients With Cancer at High Mortality Risk: A Cluster Randomized Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2418639. doi: 10.1001/jamanetworkopen.2024.18639.

  PMID: 38949813 DERIVED

• Takvorian SU, Bekelman J, Beidas RS, Schnoll R, Clifton ABW, Salam T, Gabriel P, Wileyto EP, Scott CA, Asch DA, Buttenheim AM, Rendle KA, Chaiyachati K, Shelton RC, Ware S, Chivers C, Schuchter LM, Kumar P, Shulman LN, O'Connor N, Lieberman A, Zentgraf K, Parikh RB. Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Implement Sci. 2021 Sep 25;16(1):90. doi: 10.1186/s13012-021-01156-6.

  PMID: 34563227 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Samuel Takvorian
• Organization: Abramson Cancer Center

Samuel.takvorian@pennmedicine.upenn.edu

267-438-8269

Study Officials

• Samuel Takvorian, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Ravi Parikh, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible clinicians and patients will be independently randomized to receive nudges using a 2x2 factorial design.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: September 9, 2021
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)