N/A
Completed N=4,450
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
Source: ClinicalTrials.gov NCT04867850 ↗Enrolled (actual)
4,450
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC) — 112; 136; 115; 179 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC) |
112; 136; 115; 179 | — |
| SECONDARY Number of Patients With SIC Documentation (Out of All Patients, Regardless of Risk Level) |
— | — |
| SECONDARY Number of High Risk Patients With a Palliative Care Referral |
84; 94; 81; 97 | — |
| SECONDARY Number of Decedent High Risk Patients Who Received Aggressive End-Of-Life Care |
76; 95; 62; 97 | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT04867850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.