N/A
N=2,512
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)
Dementia · Chronic Disease · Neoplasm Metastasis · Lung Neoplasm · Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT04281784 ↗Enrolled (actual)
2,512
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Proportion of Patients With EHR Documentation of Goals of Care Discussions — 433; 382; 822; 875 Participants — p=0.027
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EHR-based Clinician Jumpstart (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With EHR Documentation of Goals of Care Discussions |
433; 382; 822; 875 | 0.027 sig |
| SECONDARY Intensity of Care/ICU Use: ICU Admissions |
— | — |
| SECONDARY Intensity of Care/ICU Use: ICU Length of Stay (Number of Days Alive and Out of the ICU) |
27.90; 27.83 | 0.750 |
| SECONDARY Intensity of Care/Hospital Use: Hospital Length of Stay (Number of Days Alive and Out of the Hospital) |
21.99; 21.63 | 0.312 |
| SECONDARY Intensity of Care: Hospital Readmissions 30 Days |
265; 251 | 0.475 |
| SECONDARY Intensity of Care: ICU Admissions 30 Days |
336; 348 | 0.610 |
| SECONDARY Total Hospitalization Costs, Randomization to 30 Days After Randomization |
21,908.67; 22,386.40 | 0.710 |
| SECONDARY All-cause Mortality at 30 Days After Randomization (Safety Outcome) |
64; 70; 1193; 1185 | 0.588 |
| SECONDARY Total Hospitalization Costs, Randomization to Index Hospitalization Discharge |
24,384.68; 23,724.06 | 0.685 |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04281784). 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.