Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
NCT04283994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 756
Last updated 2025-06-24
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 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
- Dementia
- Chronic Disease
- Neoplasm Metastasis
- Lung Neoplasms
- Pulmonary Disease, Chronic Obstructive
- Heart Failure, Congestive
- Liver Cirrhosis
- Kidney Failure, Chronic
- Lung Diseases, Interstitial
- Peripheral Vascular Disease
- Diabetes With End Organ Injury
Interventions
- BEHAVIORAL
-
Survey-based Patient/Clinician Jumpstart
The Jumpstart Guide is a communication-priming intervention for clinicians, patients and their families that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The Jumpstart takes two forms. One is "EHR-based" and provides information to the clinician about prior advance care planning documentation derived from the EHR. The other is "bi-directional" and patient-specific (Survey-based Patient/Clinician Jumpstart Guide). It provides the same information as the EHR-based Clinician Jumpstart Guide but also includes information about patients' self-reported preferences for communication and care as well as primary barriers and facilitators to this communication. The Jumpstart Guides include tips to improve this communication for clinicians, patients and families.
- BEHAVIORAL
-
EHR-based Clinician Jumpstart
The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page EHR-based Clinician Jumpstart Guide provides information to the clinician about prior advance care planning documentation derived from the EHR. The EHR-based Clinician Jumpstart Guide includes tips to improve goals-of-care communication.
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH - lead OTHER
Principal Investigators
-
Erin K Kross, MD · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-26
- Primary Completion
- 2023-12-01
- Completion
- 2025-01-27
Countries
- United States
Study Locations
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