Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Renal Insufficiency

Kidney Failure, Chronic

Neoplasm Metastasis

Liver Cirrhosis

Diabetes Mellitus

Vascular Diseases

Lung Neoplasms

Dementia

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Heart Failure

Peripheral Arterial Disease

Peripheral Vascular Diseases

Chronic Disease

Lung Diseases, Interstitial

Heart Diseases

Neoplastic Processes

Respiratory Tract Diseases

Fibrosis

Liver Diseases

Gastrointestinal Diseases

Disease Attributes

Lung Diseases, Obstructive

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Atherosclerosis

Arteriosclerosis

Arterial Occlusive Diseases

Renal Insufficiency, Chronic

Chronic Graft Versus Host Disease

The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient 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 and patients' code status.

The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.

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 Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication.

EHR-based Clinician Jumpstart

J. Randall Curtis, MD, MPH

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.

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)) and patients' code status. This information is provided by email 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.

This current study is "Trial 1" of the R01 Award funding this trial. Trial 2 was initiated following the completion of recruitment for Trial 1.

SPECIFIC AIM 1 (for Trial 1): Evaluate the efficacy of the EHR-based clinician Jumpstart compared to usual care for improving quality of care.

TRIAL 1 has three components.

Component 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.

Component 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 of POLST, advance directives and DPOA (durable power of attorney) documentation and the patients' code status. It also provides general recommendations to initiating goals of care discussions. Jumpstart guides are prepared for the intervention group only.

Component 3- Delivery of the intervention: For the intervention group, the investigators deliver the Jumpstart guide to the primary hospital team (attending and resident physicians and advanced practice providers) via secure email. 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 2 (Trial 1): Evaluate implementation of the Jumpstart Guide and identify barriers and facilitators to future implementation.

Qualitative evaluation:

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.

Quantitative evaluation:

Quantitative evaluation for Specific Aim 2 will be guided by the RE-AIM framework. We will evaluate the intervention's: 1) Reach (% of all identified eligible clinicians, patients and families that participated in the study); 2) Adoption (% of eligible services that participated); and 3) Implementation (the proportion of HTML Jumpstart Guides that were opened by a clinician, proportion of patients for whom an HTML JS guide was sent and for whom a JS was opened by a clinician).

Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)

Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods.

Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR.

Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the ICU within 30 days from randomization will be collected from the EHR.

Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the hospital within 30 days from randomization will be collected from the EHR.

Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients readmitted to the hospital following index hospitalization.

Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients who received ICU care.

Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

From Washington State death certificates.

National Institute on Aging (NIA)

University of Washington

Research Professor; Cambia Palliative Care Center of Excellence; Pulmonary, Critical Care and Sleep Medicine

No study-related Serious Adverse Events are expected. The Jumpstart intervention is a communication intervention and is unlikely to result in fatal or life-threatening outcomes.

The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient 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 and patients' code status.

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 Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication.

Usual Care

The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status.

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 Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Janaki Torrence, Research Coordinator

Usual care = reference group; intervention arm = comparison group

Proportion of Patients With EHR Documentation of Goals of Care Discussions

Intensity of Care/ICU Use: ICU Admissions

Intensity of Care/ICU Use: ICU Length of Stay

Intensity of Care/Hospital Use: Hospital Length of Stay

Intensity of Care: Hospital Readmissions 30 Days

Intensity of Care: ICU Readmissions 30 Days

Intensity of Care: Healthcare Costs

All-cause Mortality at 1 Year (Safety Outcome)

Overall Study

Alzheimer Disease

Brain Diseases

Central Nervous System Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Familial Alzheimer Disease

The Jumpstart Guide is developed using automated methods. It summarizes the presence/absence of POLST, advance directives and DPOA documentation. The Jumpstart Guide also provides tips for conducting discussion about goals of care.

Clinicians of patients in the Usual Care arm will not receive a Jumpstart Guide.

The Jumpstart Guide is a communication-priming intervention for clinicians, patients and their families in the outpatient setting. The intervention's goal is to prompt clinicians to provide, during a scheduled (non-urgent) clinic visit, standard of care which includes a discussion with patients (and/or their LNOKs) about their goals of care. It is designed to promote and guide these discussions for older adults with memory problems through suggestions and tips on the Jumpstart Guide.

Jumpstart Guide

Elizabeth Nielsen

Jessica Walsh

Erin Kross, MD

The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.

This is an NIH Stage III hybrid efficacy-effectiveness trial that also capitalizes on insights from the hybrid effectiveness-implementation design. This is a parallel group randomized trial randomizing patients with ADRD to Jumpstart or usual care. Jumpstart is designed to promote and guide goals-of-care discussions for patients with serious illness through suggestions and "tips" on the Jumpstart Guide. The guide also includes patient-specific information gathered from the EHR on the presence of advance directives and POLST forms. This trial is also pragmatic because we will enroll all eligible patients; Jumpstart guides will be delivered to clinicians caring for all patients in the intervention arm. Patient-reported outcomes will only be collected from patients and families willing to complete surveys. The primary outcome, EHR documentation of goals-of-care discussions, will be collected for all patients.

The study includes 4 steps:

Step 1. Patient Identification and randomization. Patients are randomized at the time of confirmation of eligibility to one of two study arms: the Jumpstart intervention or usual care.

Jumpstart is a communication-priming intervention for clinicians, patients and their families in the outpatient setting. The intervention's goal is to prompt clinicians to provide, during a scheduled (non-urgent) clinic visit, standard of care which includes a discussion with patients (and/or their LNOKs) about their goals of care. It is designed to promote and guide these discussions for older adults with ADRD through suggestions and tips on the Jumpstart guide.

Step 2. Creation of EHR-based Jumpstart Guide. For patients randomized to intervention, a "clinician-facing" Jumpstart guide is created. The Jumpstart guide is developed from EHR data, using automated retrieval routines to summarize the presence or absence of Physician Orders for Life Sustaining Treatment (POLST), advance directives, and durable power of attorney (DPOA) for health care documentation. This information is used to populate the Jumpstart guide with tailored recommendations to clinicians for initiating or continuing goals of care discussions at the patient's upcoming "target visit" appointment. No Jumpstart guides are created for patients in the comparator arm.

Step 3. Delivery of Jumpstart Guide to Clinician. Jumpstart guides are delivered within 1-2 days prior to the patient's targeted appointment via secure email or in person to the clinician who is caring for the study patient in the outpatient setting. Study staff monitors the EHR via EPIC to confirm appointment attendance, or to revise the target visit date if the appointment is rescheduled. The study does not contact clinicians for patients in the comparator arm; however, the target visit is tracked and logged in order to collect outcome data.

Step 4. Recruitment of Patients and Family Members for Surveys. At approximately 2 weeks after the target visit, patients are contacted to participate in survey activities. Recruitment is as noted above. Surveys are distributed to patients and family members in both study arms at 1-, 3-, and 12-months after a target visit. These time points are designed to maximize subjects' ability to recall occurrence of a goals-of-care discussion (1-month) while also allowing time for the communication intervention to impact care plans and other patient-centered outcomes (3- and 12-months). Surveys assess patient outcomes, including palliative care needs, healthcare utilization and intensity of care, and psychological symptoms. Family surveys include items that allow the family to assess the patient outcomes from the caregiver's perspective as well as caregiver outcomes. Surveys may be completed in-person, online (REDCap), or by phone, based on subjects' preferences.

A legal next of kin is identified for all patients in case patients are unable to complete surveys at any time during their 12-month period of study participation. We use the same procedures for them at later time points that are used at initial recruitment and enrollment.

Qualitative Interviews. At the end of the participants' follow-up period, intervention patients and family members are invited to take part in a short, semi-structured interviews to evaluate the intervention. The interviews will last about 20-30 minutes. This subset of subjects is contacted by the study team by mail, email, telephone or in-person, based on their preference determined at enrollment. We use purposive sampling to select individuals representing diverse demographics (i.e., age, gender, race, ethnicity, dementia severity) and various levels of participation in the intervention.

Clinicians are identified by the study team using purposive sampling to identify those who participated fully in the intervention component and those who were sent the Jumpstart guide but did not document a goals-of-care discussion. They are also selected using purposive sampling to ensure a diverse group based on race/ethnicity, age, gender, specialty, and years of training.

Interviews explore feedback on the intervention and ways to improve intervention delivery and implementation, including three key implementation outcomes (acceptability, fidelity, penetration) that will guide future dissemination of the intervention. They are conducted in person, by video conference, or by phone, depending on the participant's preference. Interviews are audio recorded, transcribed, and analyzed using thematic analysis. To ensure trustworthiness and accuracy, interviewers (research coordinators) may perform a "member check" of the results with participants selected.

Additional Data Collection: We use EHR-based quality metrics program to obtain data about patients from the EHR, including those data required for screening and for primary and secondary outcomes. (See below.) We collect these data using our automated and validated methods within UW Medicine from the EHR using UW Medicine's Enterprise Data Warehouse (EDW), a repository of data from multiple sources including clinical, supply chain, billing, and human resources. We collect healthcare utilization outside of UW Medicine through participant surveys, along with occurrence and place of death (if death occurs within 24 months from patient enrollment) from the EHR and Washington State death certificate data.

Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers

Hybrid Efficacy-effectiveness Trial to Promote Goals-of-care Discussions for Patients With Alzheimer's Disease and Related Dementias and Their Family Caregivers

The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the EHR in the period by 90 days following randomization. The proportion is the number of patients with GOC documentation over the number of patients in each study arm.

Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)	NCT04281784	Dementia Chronic Disease Neoplasm Metast... Lung Neoplasm Pulmonary Disea... Heart Failure，C... Liver Cirrhosis Kidney Failure,... Lung Diseases, ... Peripheral Vasc... Diabetes With E... Palliative Care... Health Care Qua... Patient Care Inpatients Health Communic... Patient Care Pl...	EHR-based Clini...	18 Years -	University of Washington
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)	NCT04281784	Dementia Chronic Disease Neoplasm Metast... Lung Neoplasm Pulmonary Disea... Heart Failure，C... Liver Cirrhosis Kidney Failure,... Lung Diseases, ... Peripheral Vasc... Diabetes With E... Palliative Care... Health Care Qua... Patient Care Inpatients Health Communic... Patient Care Pl...	EHR-based Clini...	18 Years -	University of Washington
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers	NCT05596760	Dementia Chronic Disease Neoplasm Metast... Lung Neoplasm Pulmonary Disea... Heart Failure，C... Liver Cirrhosis Kidney Failure,... Lung Diseases, ... Peripheral Vasc... Diabetes With E... Palliative Care... Health Care Qua... Patient Care Health Communic... Patient Care Pl... Quality of Life	Jumpstart Guide	18 Years -	University of Washington

Spots Global Cancer Trial Database for heart failure，congestive