NCT04283994Completed
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 · Last updated 24 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 756 (actual)
- First submitted
- 19 Feb 2020
- Start date
- 26 Jul 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- University of Washington
- Diseases
- Heart failure, COPD, Lung cancer
- NCT number
- NCT04283994
What you commit to
- Study type: Interventional
- Participants enrolled: 756
- From 26 Jul 2021 to the primary completion date, 1 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harborview Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| UW Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| UW Medical Center - Northwest Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.