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.

Associate Professor: School of Medicine, Pulmonary, Critical Care and Sleep Medicine

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

This intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers.

Carevive CPS

The overarching objective of this study is to evaluate the symptom assessment and management behaviors used by multiple myeloma (MM) providers for alignment with evidence-based practices, and to explore changes in these symptom care behaviors from baseline to following use of the Carevive Care Planning System (CPS). The overarching goal of the larger program of research is to evaluate the impact of the platform on symptom assessment and management strategies with individuals receiving treatment for multiple myeloma. The current study is focused on determining feasibility of research methods and effect size finding so as to gather the requisite data needed to design fully powered hypothesis testing studies.

Treatment of multiple myeloma (MM) is currently undergoing rapid transformation. With so many new agents and regimens to choose from, significant practice gaps have emerged in the treatment and management of newly diagnosed MM patients. Innovative strategies are needed to (1) enhance the personalized treatment of MM and (2) proactively identify, assess, and manage disease- and treatment-related symptoms so that new therapies are optimally translated to practice. This study will explore the symptom assessment and management practices of providers caring for individuals receiving active therapy for multiple myeloma, and will also employ a two-part intervention (with both patients and providers) to evaluate the impact of a novel existing technology, the Carevive Care Planning System (CPS), on supportive care and symptom management for multiple myeloma patients. The primary objective of this study is to evaluate provider adherence to evidence-based practices for symptom assessment and management (i.e., "symptom care behaviors") of physicians and nurses (providers) caring for individuals receiving active treatment for multiple myeloma (MM). Carevive. The Carevive intervention will include personalized supportive care and symptom management plans for patients auto-generated by the Carevive CPS based on each individual's data. The Care plans were created based on nationally recognized National Comprehensive Cancer Network (NCCN) supportive care guidelines and validated by a Multiple Myeloma (MM) nurse and physician experts. Investigators will use a study-specific scorecard of evidence-based symptom assessment and management metrics to evaluate adherence of provider (n=8-20) symptom assessment and management behaviors, measured at the individual patient (n=120) level, to evidence-based practices for symptom care. Changes in adherence to evidence-based practices will be explored using an across subject comparison to retrospective data abstracted from a matched sample of historical controls. Use of a care planning technology to provide tailored education and individualized information may provide an easy, accessible and effective way to improve supportive care and symptom management for individuals receiving active treatment for multiple myeloma.

Multiple myeloma (MM) is a neoplastic plasma-cell disorder characterized by clonal proliferation of malignant plasma cells in the bone marrow microenvironment, monoclonal protein in the blood or urine, and associated organ dysfunction. In 2014, approximately 24,050 new cases of MM will be diagnosed and 11,090 deaths are expected to occur. The treatment of MM is currently undergoing a rapid evolution. The FDA has approved several new agents over the past several years. Dozens of regimens are now available, with best practices and consensus guidelines continually evolving as new data are published. Indeed, major updates to the International Myeloma Working Group (IMWG) and the 2014 National Comprehensive Cancer Network (NCCN) guidelines highlight the recent revolution in MM care.

With so many agents and regimens to choose from, it is more crucial now than ever for providers to understand how to individualize treatment and symptom management based on patient- and disease-related factors. However, significant practice gaps exist among providers treating patients newly diagnosed with MM. Transplant eligibility, cytogenetics, comorbidities, renal function, and other factors are often not adequately considered when designing personalized induction, consolidation, and maintenance treatment plans. In addition, institutional MM pathways often do not include symptom management. Adverse events are common in patients with MM, and can be dose limiting, forcing patients to change therapies and jeopardize treatment outcomes.

A between subject design using matched historical controls from each institution will be used to evaluate adherence of provider (n=8-20) symptom assessment and management behaviors, measured at the individual multiple myeloma (MM) patient (n=120) level, to evidence-based practices for symptom care, and to explore correlates of adherence to these evidence-based symptom care behaviors. Retrospective reviews of enrolled patient participant charts will be conducted to evaluate achievement of adherence to evidence-based practices at the individual patient level, following engagement with the two part study intervention, plus a novel individualized care planning technology (Carevive CPS). Retrospective chart reviews will be completed on de-identified, matched historical controls (matching on demographics, diagnosis and treatment variables) at each institution (e.g Cleveland Clinic) to assess the impact of the project intervention on the outcome metrics. Data will be entered into the score card appendix B. The use of matched historical controls for comparative analyses addresses the threat of diffusion of intervention; i.e., that participation in this project will have an impact on provider's clinical behaviors in caring for all patients and thus would potentially effect baseline data collection on patients enrolled later on in the study. Providers will be caring for individuals receiving active treatment for multiple myeloma (MM).

The Carevive CPS intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers. Changes in symptom assessment and management behaviors will be assessed by matching against a scorecard of evidence-based symptom assessment and management metrics. A scorecard metric is being developed by an interdisciplinary team and will be informed by similar approaches used within the Oncology Nursing Society's (ONS) Quality Initiative. Recommendations for symptom assessment and management as well as other evidence based recommendations will be operationalized as metrics.

The intervention is centered on use of the Carevive CPS at the point of care, in conjunction with two consecutive clinical visits, baseline and the second, similar questionnaire will be completed at a clinic visit that occurs at least 4 weeks later. Eligible patients and potentially eligible visits will be identified via weekly chart review of upcoming clinic schedules and of corresponding individual patient medical records. In the exam room, prior to their potential baseline study visit, the patient will be approached and informed of the study (for follow-up visits, patients will be approached and reminded of the study). Once a patient has consented, research staff will open the electronic questionnaire via the Carevive CPS application on one of the study designated tablet computers or secure Cleveland Clinic desktop device according to patient preference . Research staff will then either a) register the patient using their year of birth and a unique Study ID numbers assigned by the Cleveland Clinic or b) open the patients' already existing file (follow-up). The research staff will then select and open the appropriate questionnaire (baseline or interim) and allow the patient to complete. The patient will report their symptoms, history, and current concerns. Once the patient has completed the questionnaire, the survey window will automatically close. Data will be stored centrally and managed by a third party (PRS) in a HIPAA compliant manner. The study research coordinator will then enter limited clinical data into the Diagnosis and Treatment Summary section of the Carevive CPS and click submit. Once submitted, the total composite of ePRO and research staff entered data will run through the guideline-driven and proprietary Carevive CPS algorithms to auto-generate a draft supportive care plan. The draft care plan contains, based on individual patient data, personalized supportive care and symptom management data to be reviewed by the provider during visit. The patient will proceed to the intervention visit where the provider will review, edit if needed, finalize and deliver the electronic care plan (and/or a print copy) to each patient. The patient will also be provided with his or her own copy of the care plan (electronically via email, thumb drive and/or paper) to take home.

Research staff will track patient enrollment and monitor return visits for all participants that fall within the follow-up visit window which begins at least 4 weeks later (+/- 1 week) and continues until the second survey is completed. At this follow up visit, the study patients will take their second electronic survey in the Carevive CPS, and receive their second provider-approved care plan. Patients will also be offered the opportunity to complete a brief questionnaire on their satisfaction with, and utilization of, the care plan since their first intervention visit. The questionnaire will ask about specific recommendations made within the care plan and if the patient recalls receiving it and what action, if any, they have taken. Patients will be offered the opportunity to complete this survey on the study provided tablet or secure Cleveland Clinic desktop device at the time of their second visit or to have a link to the survey emailed to them to be completed at their leisure. This survey will be completed independently of the Carevive CPS through the on-line survey hosting site Surveymonkey.com and will be optional for patients.

Study-specific data collection will occur at multiple time points. Chart reviews of enrolled patient participants will the period of time from baseline intervention (baseline visit) to 12-weeks post the second intervention (encompassing the follow-up visit). Retrospective chart abstractions for the matched controls examine a 12-week time period matched as close as possible to the intervention time period of their respective enrolled patients. Retrospective chart reviews can occur at any time. Chart reviews must reflect the time period of enrolled patients. Patient satisfaction and utilization questionnaire will be completed at or following the follow-up visits. Data sources include the patient questionnaire, previously collected data collected as part of the study intervention and stored within the Carevive CPS platform database (for enrolled patients) limited diagnosis and treatment data on controls (for matching purposes), as well as chart review score card data. A brief worksheet collecting care plan delivery variables (e.g., who delivered the care plan to the patient, how much time was spent reviewing the care plan, etc.) will also be completed by the research staff following each clinic visit at which a care plan is delivered.

Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans

Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans: Pilot Testing the Impact of Continuing Education and Care Planning on Symptom Management

Charts will be abstracted and data will be entered into scorecards to determine whether participating providers adhered to evidence-based practices for symptom assessment and management for study participants.

Charts will be abstracted and data will be entered into scorecards to explore changes in symptom care behaviors following engagement with a supportive care intervention (the Carevive CPS), and compare to adherence rates for historical controls from the pre-intervention period.

Clinicians will complete a qualitative survey at the end of the study to report the amount of time they spent reviewing and delivering care plans with study participants.

The study will explore patient satisfaction and utilization of care plans by asking patients a series of qualitative questions.

Carevive Systems, Inc.

Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania

Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania

Patients with an evaluation \& management claim attributed to a medical oncology pilot practice in southeastern Pennsylvania

Patients with an evaluation \& management claim attributed to a medical oncology comparison practice in southeastern Pennsylvania

Patients with a new diagnosis of cancer in the past two years

Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

Pilot of Patient-Centered Oncology Care

Sarah H Scholle, DrPH, MPH

The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were:

1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?

The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices.

Background. Advances in cancer treatment mean that a growing number of Americans are living with cancer and experiencing it as a chronic, long-term condition. National panels led by consumers have identified the need for improved cancer care in the areas of communication between providers and patients and their families, care planning, attention to nonmedical needs, care coordination and provision of evidence-based treatment. The patient-centered medical home (PCMH) model of care is being widely adopted as a way to provide accessible, proactive, coordinated care and self-care through primary care practices. During active treatment for cancer, the oncology practice is often the primary setting supporting the patient and coordinating cancer treatment. By implementing the patient-centered medical home model, an innovative oncology practice in Pennsylvania has been able to improve access and reduce emergency department visits and hospitalizations for its patients.

Objectives. Building on these recommendations and experience, the National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. We sought PCORI support to pilot and evaluate this model. Specific research questions were:

1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?

Methods. The demonstration occurred in 5 oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices. Patients, clinicians, and health plan leaders helped design the project, and disseminate results. The project used Patient Centered Outcomes Research Institute (PCORI) resources efficiently by building on ongoing efforts. Our evaluation consisted of a retrospective, pre-post study design with a concurrent non-randomized control group of 18 local practices for the utilization and patient experience outcomes. We used difference-in-difference regression models that accounted for practice-level clustering and used functional forms appropriate to the dependent variables. For quality, we compared baseline and follow-up pilot practice performance to national and regional benchmark performance data.

Patient Outcomes. People with cancer are seeking high quality, coordinated and supportive care. The Patient-Centered Oncology Model has the potential to address current gaps in cancer care.

Evaluating the Impact of Patient-Centered Oncology Care

Patient experience survey composite scores were evaluated in the pilot practice group and in the comparison practice group during the intervention period and the follow-up period using a modified version of the cancer CAHPS patient survey.

We calculated survey composite scores on a 0-100 scale using proportional scoring and the summated rating method based on the CAHPS macro.This method calculates the mean responses to each survey item in the composite, after transforming each response to a 0-100 scale (100 representing the most positive response on any given item response scale; 0 representing the least positive). For example, on a Yes/No response scale, if "Yes" represents the most positive response, then Yes= 100 and No = 0; on an Always/Usually/Sometimes/Never response scale, if "Always" represents the most positive response, then Always = 100, Usually = 67, Sometimes = 33 and Never = 0. A higher score means that practices were rated more positively for care on that item.

Quality measure performance rates were evaluated in the pilot practice group during the baseline period and the follow-up period. Data were abstracted from medical records for a sample of patients diagnosed with an invasive malignancy within previous 2 years and with at least 2 visits to the practice in the previous six months at baseline and at 36 months follow-up.

Per member per month hospitalizations, emergency department visits, primary care visits and specialist visits were evaluated in the pilot group and in the comparison group using insurance claims data during the baseline, start-up, intervention and follow-up periods.

American Society of Clinical Oncology

Independence Blue Cross

National Coalition for Cancer Survivorship

Oncology Management Services

RAND

National Committee for Quality Assurance

All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed

Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania

Intervention:

Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

Pilot Practices Patient Survey Cohort

Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania

Intervention:

No intervention/Usual care

Comparison Practices Patient Survey Cohort

Pilot Practices Utilization Cohort

Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania

Intervention: No intervention/Usual care

Comparison Practices Utilization Cohort

Patients with a new diagnosis of cancer in the past two years

Intervention:

Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

Pilot Practices Quality Measures Cohort

18-24

25-54

55-64

65-74

75 and older

Unknown

Age, Customized

Female

Male

Sex/Gender, Customized

White

Black/African-American

Asian

American Indian/Alaska Native

Native Hawaiian/Pacific Islander

Other

Hispanic/Latino

Race/Ethnicity, Customized

Sarah Hudson Scholle

To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

Affective Communication Composite-Start-Up

Affective Communication Composite-Follow-Up

Access Composite-Start-Up

Access Composite-Follow-Up

Exchanging Information Composite-Start-Up

Exchanging Information Composite-Follow-Up

Patient Self-Management Composite-Start-Up

Patient Self-Management Composite-Follow-Up

Only the Pilot Practices Patient Survey Cohort and Comparison Practices Patient Survey Cohort were pre-specified to be assessed for this Primary Outcome.

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
Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans	NCT03046329	Multiple Myelom...	Carevive CPS	18 Years -	Carevive Systems, Inc.
Evaluating the Impact of Patient-Centered Oncology Care	NCT02110758	Neoplasms	Pilot of Patien...	18 Years -	National Committee for Quality Assurance
Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans	NCT03046329	Multiple Myelom...	Carevive CPS	18 Years -	Carevive Systems, Inc.
Goals of Care Conversations Study	NCT05001009	Seriously Ill P... Cancer Heart Failure Interstitial Lu... Chronic Obstruc... End-stage Renal... End-stage Liver... Dementia	Clinician Imple... Clinician Imple... Low patient eng... High patient en...	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for patient care planning