N/A
N=4,450
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04867850 ↗Enrolled (actual)
4,450
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC) — 112; 136; 115; 179 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care (Other); Clinician Nudge (Other); Patient Nudge (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Sep 2022
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 | — |
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.
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.