Clinical trial · Interventional
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
Effect of Behavioral Nudges to Clinicians, Patients, or Both on Serious Illness Conversation Documentation for Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinician Nudge | Other | — | UNRESOLVED |
| Patient Nudge | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- 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.
- interventionNames
- Other: Usual Care
- type
- EXPERIMENTAL
- label
- Clinician Nudge
- description
- 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.
- interventionNames
- Other: Clinician Nudge
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Clinician (M.D., P.A., or N.P.) participants must meet the following criteria: 1\. 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: 1. Receive care for a solid, hematologic, or gynecologic malignancy from an eligible provider at a participating PennMedicine Implementation Lab site 2. Have at least one scheduled Return Patient Visit (either in person or via telemedicine) with an eligible PennMedicine provider during the study period Exclusion Criteria: Clinicians will be ineligible for \*any\* of the following reasons: 1\. Provide exclusively benign hematology, survivorship, and/or genetics care Patients will be ineligible for \*any\* of the following reasons: 1. Previously documented SIC within 6 months 2. Have a non-valid phone number
References
Publications (2)
- DERIVEDTakvorian 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
- DERIVEDTakvorian 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