Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)
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 over the age of 65 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 during the hospitalization. Secondary
 outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care
 during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a
 mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the
 RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments
 of effectiveness, implementation and maintenance and qualitative assessments of clinician
 perspectives on barriers and facilitators to future implementation and dissemination.
OVERVIEW: This is a large pragmatic trial of the Jumpstart intervention designed to promote
 goals-of-care discussions for older, seriously ill, hospitalized patients. The trial recruits
 consecutively eligible patients from three UW Medicine hospitals. The Jumpstart Guide is a
 communication-priming intervention that addresses hospitalized patients' goals of care. It
 includes information, drawn from the electronic health record (EHR), identifying the dates
 and locations of prior advance care planning documents (e.g. living wills, healthcare
 directives, durable power of attorney for healthcare, and Physician Orders for Life
 Sustaining Treatments (POLST)). This information is provided by email and in-person to
 patients' clinicians. The Jumpstart Guide includes tips to improve this communication. The
 trial will assess the effectiveness of the EHR-based clinician Jumpstart as compared with
 usual care.

 SPECIFIC AIM (Trial 1): Evaluate the EHR-based clinician Jumpstart compared to usual care.

 Intervention. Step 1- Subject Identification/Recruitment/Randomization: The investigators
 will use automated methods with EHR data, including natural language processing/machine
 learning (NLP/ML) approaches, to identify hospitalized patients with serious illness during
 the first 2-3 days of this specific admission. Screening reports will be produced daily and
 include all likely eligible patients. Study staff will use these daily screening reports to
 review individual records of eligible patients for inclusion and exclusion criteria (i.e.
 verify eligibility). Patients will not be approached for consent. Eligible patients will be
 assigned to intervention or comparator in a 1:1 ratio. Patients are randomized using variable
 size blocks and stratified for hospital and ADRD vs. no ADRD.

 Step 2- EHR-based Clinician Jumpstart Guide: The Jumpstart guide is developed by applying
 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 summarizes
 the presence/absence patients' prior goals-of care discussions and the presence/absence of
 POLST, advance directives and DPOA (durable power of attorney) documentation. It also
 provides general recommendations to initiating goals of care discussions. Jumpstart guides
 are prepared for the intervention group only.

 Step 3- Delivery of the intervention: For the intervention group, the investigators deliver
 the Jumpstart guide to the primary hospital team (all attending and resident physicians and
 advanced practice providers) via secure email, or in person delivery. The Jumpstart guides
 are delivered within 1 business day of patient randomization. Study staff monitor the care
 team of the patient, and if there are any changes, ensure that any new providers receive the
 Jumpstart guide as well.

 Comparator: The hospital teams for patients in the control group do not receive Jumpstart
 guides.

 Outcome Assessment. Outcomes are obtained from the EHR and use, in part, NLP/ML methods. The
 primary outcome is EHR documentation of goals-of-care discussions in the 30 days following
 randomization. Secondary outcomes are measures of intensity of care, including utilization
 metrics (i.e., ICU admissions, ICU and hospital lengths of stay, 30-day hospital
 readmissions), costs of care during hospital admission, and estimated costs of implementing
 the intervention.

 SPECIFIC AIM (Trial 1): Evaluate implementation of the Jumpstart Guide and identify barriers
 and facilitators to future implementation.

 Clinician recruitment: Study staff will recruit clinicians who were involved with the study
 to participate in a short interview after the clinician's study involvement with the enrolled
 patient has ended. Clinician participants will be selected using purposive sampling to ensure
 a diverse group (e.g., age, race/ethnicity, gender, specialty, year of training).

 Interview: Using an interview guide developed specifically for this project, interviewers
 will assess respondents' experience with the intervention and gather suggestions for ways to
 improve the intervention's content, delivery and implementation, including implementation
 outcomes (e.g., acceptability, fidelity, penetration, maintenance) that will guide future
 dissemination of the intervention.

 Assessment: Interviews are audio recorded, transcribed, and analyzed using thematic analytic
 methods. To ensure trustworthiness, interviewers will perform a "member check" of the results
 with a subset of participants selected for diversity of participant type.
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).