Clinical trial · Interventional
Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
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 is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1. To evaluate the efficacy of the EHR-based clinician-facing Jumpstart, drawn from the electronic medical record (EHR), the survey-based bi-directional Jumpstart, drawn from patient or family completed surveys, and usual care for improving quality of care provided to patients with chronic illness experiencing a hospitalization. The primary outcome is EHR documentation of a goals-of-care discussion, assessed from randomization through 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital free days, hospital readmissions, costs of hospital care); and b) patient- and family-reported outcomes assessed by surveys at 3-5 days and 4-6 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life. 2. To conduct a mixed-methods evaluation of the implementation of the interventions, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative evaluation of the interventions' 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 Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EHR-based Clinician Jumpstart | Behavioral | — | UNRESOLVED |
| Survey-based Patient/Clinician Jumpstart | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Survey-based Patient/Clinician Jumpstart
- description
- The Survey-based Patient/Clinician Jumpstart Guide will be developed with two types of data: 1) EHR data; and 2) Survey data. Using automated methods and NLP/ML algorithms, the presence/absence of POLST, advance directives and DPOA documentation will be identified from both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. The survey data will be completed by patients or their surrogate/family at enrollment and will provide assessments of the following: a) preferences for discussions about goals of care; b) most important barrier and facilitator for having such discussions; and c) current goals of care. These elements are contained within the Jumpstart guides and the information is tailored to each recipient (i.e., patient, surrogate/family, or clinician).
- interventionNames
- Behavioral: Survey-based Patient/Clinician Jumpstart
- type
- ACTIVE_COMPARATOR
- label
- EHR-based Clinician Jumpstart
- description
- The EHR-based Clinician Jumpstart Guide will be developed by using automated methods and NLP/ML algorithms to both inpatient and outpatient EHR 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. It will not include survey-based information.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility criteria apply to three subject groups: 1) seriously ill adult patients; 2) adult surrogate legal next of kin of the patients; and 3) hospital clinicians. Inclusion Criteria: PATIENTS. Eligible patients will be those who are: 1) equal to or older than 80 years of age; or 2) equal to or older than 55 years of age with one or more chronic conditions used by 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, 3) English-speaking, 4) admitted for minimum of 12 hours/maximum of 96 hours to participating in-patient services at the participating hospitals, and 5) without documentation in the EHR of a goals-of-care discussion during this admission. Patients without decisional capacity (as documented in the EHR or as identified with a brief six-item screening tool) will be represented by a legal surrogate decision maker/legal next of kin (LNOK) in accordance with Washington State Law RCW 7.70.065. SURROGATE/FAMILY. Eligible surrogate/family subjects will be those who are 18 years of age or older, English-speaking, involved in the patient's medical care or decision-making. 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 in include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation); unable to complete informed consent procedures; and without a legal surrogate to participate for them. Patients who are non-English speaking (and therefore unable to complete survey materials) are excluded. Reasons for exclusion for any surrogate/family subject include: non-English speaking (and therefore unable to complete study materials), legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires. Patients under COVID precautions will be excluded.
References
Publications (1)
- 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