Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 756
- 试验地点
- 6
- 主要终点
- EHR Documentation of Goals of Care Discussions
研究概览
简要总结
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:
- 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.
- 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.
详细描述
OVERVIEW: Jumpstart is a communication-priming intervention for clinicians, patients and their families that focuses on hospitalized patients' goals of care. In this comparative effectiveness trial, the investigators examine the effectiveness of two approaches designed to promote goals-of-care discussions for older, seriously ill, hospitalized patients recruited from three UW Medicine hospitals. The two approaches include a survey-based bi-directional intervention and an EHR-based clinician-facing intervention. Both of these interventions provide clinicians with Jumpstart Guides that include data selected from the EHR on advance care planning as well as tips designed to improve communication about patients' goals of care and care preferences. Additionally, the survey-based bi-directional Jumpstart includes not only the EHR-based care planning information but also communication tips that are based on specific information from patients' (or surrogates) self-reported surveys. These bi-directional Jumpstarts are shared not only with clinicians but also with participating patients and families. The Jumpstart Guide is provided by email and in-person. This trial tests the comparative effectiveness of the survey-based bi-directional Jumpstart, the EHR-based clinician-facing Jumpstart and usual care. Unique to this trial is the use of the EHR to identify eligible participants, provide data for the intervention, and be the mechanism for delivering the intervention.
This current study is "Trial 2" of the R01 Award funding this trial. Trial 1 was completed prior to the initiation of Trial 2.
SPECIFIC AIM 1: Evaluate the effectiveness of the survey-based bi-directional Jumpstart compared to the EHR-based clinician-facing Jumpstart and usual care for improving quality of care.
TRIAL 2 has four components.
Component 1- Subject Identification/Recruitment/Randomization: Patients who meet the inclusion criteria are screened and identified using daily screening reports and staff review. The investigators oversample patients with ADRD to include 40% of the sample. Patients are approached by study staff in person during their hospital stay to assess their interest in participating in the study. Recruitment conversations are designed to take place in the patient's hospital room. Subjects are asked to complete surveys at three time points: 1) at enrollment; 2) 3-5 days after randomization; and 3) 4-6 weeks after randomization. Follow-up surveys may be completed in-person, by paper, online, or by phone, based on respondents' preferences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PATIENTS. Eligible patients will be those who are: 1) equal to or older than 80 years of age; or 2) equal to or older than 55 years of age with one or more chronic conditions used by 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, 3) English-speaking, 4) admitted for minimum of 12 hours/maximum of 96 hours to participating in-patient services at the participating hospitals, and 5) without documentation in the EHR of a goals-of-care discussion during this admission. Patients without decisional capacity (as documented in the EHR or as identified with a brief six-item screening tool) will be represented by a legal surrogate decision maker/legal next of kin (LNOK) in accordance with Washington State Law RCW 7.70.
- •SURROGATE/FAMILY. Eligible surrogate/family subjects will be those who are 18 years of age or older, English-speaking, involved in the patient's medical care or decision-making.
- •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.
排除标准
- •Reasons for exclusion for any patient in include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation); unable to complete informed consent procedures; and without a legal surrogate to participate for them. Patients who are non-English speaking (and therefore unable to complete survey materials) are excluded. Reasons for exclusion for any surrogate/family subject include: non-English speaking (and therefore unable to complete study materials), legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires. Patients under COVID precautions will be excluded.
结局指标
主要结局
EHR Documentation of Goals of Care Discussions
时间窗: from randomization to 30 days post randomization
The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the electronic medical record (EHR) in the period between randomization and 30 days following randomization. The proportion is the number of patients with goals-of-care (GOC) documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our natural language processing/machine learning (NLP/ML) methods.
次要结局
- Patient or Surrogate/Family-reported Discussion of Goals (4-6 Weeks)(4-6 weeks after randomization)
- Intensity of Care: ICU Admissions (30 Days)(from randomization to 30 days post randomization)
- Intensity of Care: ICU Admissions (90 Days)(from randomization to 90 days post randomization)
- Intensity of Care: ICU Admissions (Post-discharge, 7 Days)(7-days post-discharge)
- Intensity of Care: ICU Admissions (Post-discharge, 30 Days)(30-days post-discharge)
- Intensity of Care: Hospital Readmissions (7 Days)(readmissions in 7 days following discharge)
- Intensity of Care: Hospital Readmissions (30 Days)(readmissions in 30 days following discharge)
- Intensity of Care: ICU Free Days (30 Days)(from randomization to 30 days post randomization)
- Intensity of Care: ICU Free Days (90 Days)(from randomization to 90 days post randomization)
- Intensity of Care: Hospital Free Days (30 Days)(from randomization to 30 days post randomization)
- Intensity of Care: Hospital Free Days (90 Days)(from randomization to 90 days post randomization)
- Patient or Surrogate/Family-reported Discussion of Goals (3-5 Days)(3-5 days after randomization)
- Quality of Communication (QOC)(3-5 days after randomization)
- SUPPORT Questions (3-5 Days)(3-5 days after randomization)
- SUPPORT Questions (4-6 Weeks)(4-6 weeks after randomization)
研究者
Erin Kross
Professor, Division of Pulmonary, Critical Care and Sleep Medicine
University of Washington