Clinical trial · Interventional
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)
Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness
- 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 objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1. To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Disease | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Diabetes With End Organ Injury | — | UNRESOLVED | — |
| Heart Failure,Congestive | — | UNRESOLVED | — |
| Kidney Failure, Chronic | — | UNRESOLVED | — |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Lung Diseases, Interstitial | — | UNRESOLVED | — |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EHR-based Clinician Jumpstart | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EHR-based Clinician Jumpstart
- description
- The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status.
- interventionNames
- Behavioral: EHR-based Clinician Jumpstart
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Primary outcomes (1)
- measure
- Proportion of Patients With EHR Documentation of Goals of Care Discussions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility criteria apply to two subject groups: 1) seriously ill adult patients; 2) hospital clinicians. Inclusion Criteria: * PATIENTS. Eligible patients will be those who are: 1) older than 80 years of age; or 2) 55 years of age or older who meet criteria for serious illness. Serious illness encompasses acute illness (e.g. COVID-19) and chronic illnesses (e.g. those included in the Dartmouth Atlas to study end-of-life care: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease). * CLINICIANS (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial. Exclusion Criteria: * Reasons for exclusion for any patient include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation).
References
Publications (3)
- BACKGROUNDCurtis JR, Lee RY, Brumback LC, Kross EK, Downey L, Torrence J, Heywood J, LeDuc N, Mallon Andrews K, Im J, Weiner BJ, Khandelwal N, Abedini NC, Engelberg RA. Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials. Contemp Clin Trials. 2022 Sep;120:106879. doi: 10.1016/j.cct.2022.106879. Epub 2022 Aug 10. PMID 35963531
- RESULTCurtis JR, Lee RY, Brumback LC, Kross EK, Downey L, Torrence J, LeDuc N, Mallon Andrews K, Im J, Heywood J, Brown CE, Sibley J, Lober WB, Cohen T, Weiner BJ, Khandelwal N, Abedini NC, Engelberg RA. Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA. 2023 Jun 20;329(23):2028-2037. doi: 10.1001/jama.2023.8812. PMID 37210665
- DERIVEDLee RY, Li KS, Sibley J, Cohen T, Lober WB, O'Brien J, LeDuc N, Mallon Andrews K, Ungar A, Walsh J, Nielsen EL, Dotolo DG, Kross EK. A modular pipeline for natural language processing-screened human abstraction of a pragmatic trial outcome from electronic health records. Clin Trials. 2026 Apr;23(2):145-154. doi: 10.1177/17407745251405386. Epub 2026 Feb 12. PMID 41680079