Clinical trial NCT04283994: Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
Official title: Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Keywords: Patient care
Inpatients
Health Communication
Patient Care Planning
Quality of Life
Health care quality, access, and evaluation
Palliative care
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-02-25
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

If patients are not able to participate themselves (e.g., cognitive impairment, sedated or ventilated), the investigators recruit their legal surrogate decision-maker to participate. This surrogate (under Washington State Law RCW 7.70.065) provides consent on their own behalf and is a research study subject.

Eligible patients are assigned to one of the three interventions in a 1:1:1 ratio. Patients are randomized using variable size blocks and stratified for hospital and ADRD vs. no ADRD. Surrogates/families follow the randomization status of the patients whom they are representing.

Component 2- EHR-based clinician-facing Jumpstart guide: The Jumpstart guide is developed from an automated review of the EHR. It summarizes the presence/absence of POLST, advance directives and DPOA documentation. It provides general recommendations to assist clinicians in initiating goals of care discussions.

Component 3- Survey-based bi-directional Jumpstart Guide: Survey data, completed by patients or their surrogate/family at enrollment provide assessments of the following: a) preferences for discussions about goals of care; b) most important barrier and facilitator for having such discussions; and c) current goals of care. These elements are contained within the Jumpstart guides and the information is tailored to each recipient (i.e., patient, surrogate/family, or clinician). This version provides survey-response specific recommendations to initiate goals of care discussions.

Component 4- Delivery of the intervention:

Clinician delivery: Guides are delivered within the first few days (1-3) after randomization to the primary clinician team (attending and resident physicians and advanced practice providers) via secure email or in person. Study staff monitor the care team for the patient and ensure that any new providers also receive the Jumpstart guide.

Patient and family delivery: For the survey-based bi-directional Jumpstart arm, study staff provide the patient or surrogate with a version of the Jumpstart guide, tailored to be appropriate for patients or their surrogates (without information on EHR-based advance care planning documents) and following the same timeframe. Jumpstart guides are delivered to the patient or surrogate/family at the hospital.

Comparison group: We will compare all 3 arms (survey-based bi-directional Jumpstart, EHR-based clinician-facing Jumpstart, usual care) in three two-way comparisons.

Outcome Assessment: The primary outcome is EHR documentation of a goals-of-care discussion in the 30 days following randomization. All subjects are asked to complete questionnaires at enrollment. The questionnaires may be completed as computer-assisted interviews or on-line depending on the subject's preference. The study staff member enrolling the subjects notifies them of their randomization status at this time. Subjects randomized to the survey-based bi-directional Jumpstart arm complete additional questionnaire items used to create the Jumpstart Guide.

The research staff will contact all subjects in person (or by telephone or email) for the evaluation/post-intervention phase. Patient and surrogate/family subjects will complete surveys at 3-5 days and 4-6 weeks after randomization. Surveys can be completed by telephone, mail, or online; we will contact each patient or family/surrogate at each interval using their preferred modality. Subjects may complete the surveys with study staff in person (if the patient is still in the hospital), over the phone, online using REDCap, or on paper and return via mail. Surrogate/Family subjects will complete the same measures at the same intervals as patients with a few exceptions: families will complete the SF-1 for themselves as well as by proxy for patients.

Follow up contacts for subjects at 3-5 days follow-up will be as follows: If the patient is still hospitalized, in-person contact will be attempted (surrogates, who may not be reachable in person, may be contacted by their preferred mode); otherwise, contact will be attempted via phone, email, or mail per the subject's preference. Second and third contact attempts will be made using the subject's preferred mode 2 and 4 days later (7 and 14 days later for mail).

Follow-up contacts for subjects at 4-6 weeks follow-up will be as follows: initial contact by subject's preferred mode at 4 weeks from enrollment, followed by 4 additional contacts at an interval of every 4-7 days for phone and online, and an interval of every 7-10 days for mail. In all cases, only non-respondents will continue to be contacted.

For surrogates of patients who have died, after a minimum of 4 weeks following the patient death, an "after death" questionnaire will be sent to the subject using their preferred mode. The after-death questionnaire includes items related to treatment preferences, psychological distress (HADS), and health-related quality of life (SF1). The after-death questionnaire will be sent one time with no additional follow-ups.

At the end of study participation, study staff will collect additional information from the patient's electronic health record including intensity of care outcomes. Data will be abstracted using automated EHR data collection and "gold standard" manual abstraction using standardized methods for training and quality control.

Secondary outcomes also include the following patient- and surrogate/family-reported outcomes assessed by survey at 3-5 days and 4-6 weeks after randomization: occurrence and quality of goals-of-care communication in the hospital, goal concordant care, psychological symptoms, and quality of life.

SPECIFIC AIM 2: Evaluate the factors affecting the Jumpstart intervention implementation and identify barriers and facilitators to future implementation.

Patient and Surrogate/Family Subject Identification and Recruitment: Included in the patient's and surrogate/family member's consent form is a provision informing subjects that they may be contacted at the end of their study involvement to take part in a short, semi-structured interview to evaluate their study participation. Subjects will be sampled purposively to represent the following experiences: 1) participants from both intervention arms (EHR-based and survey-based); 2) participants who participated in the intervention fully as well as those who did not to better understand the reasons for less than full participation. "Full" participation is indicated by having completed all of the study materials.

Clinician Subject Identification and 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.

All interview participants will be selected using purposive sampling to ensure a diverse group (e.g., age, race/ethnicity, gender, specialty, year of training) in addition to the characteristics noted above.

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 analysis. Validity and reliability are assessed by co-coding approaches.

Eligibility criteria: Eligibility criteria apply to three subject groups: 1) seriously ill adult patients; 2) adult surrogate legal next of kin of the patients; and 3) hospital clinicians.

Inclusion Criteria:

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 7.70.065.

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: EHR Documentation of Goals of Care Discussions
timeFrame: from randomization to 30 days post randomization
Secondary outcomes:
measure: Intensity of Care/ICU Use: ICU Admissions (30 Days)
timeFrame: from randomization to 30 days post randomization
measure: Intensity of Care/ICU Use: ICU Admissions (90 Days)
timeFrame: from randomization to 90 days post randomization
measure: Intensity of Care: ICU Admissions (Post-discharge, 7 Days)
timeFrame: 7-days post-discharge
measure: Intensity of Care: ICU Admissions (Post-discharge, 30 Days)
timeFrame: 30-days post-discharge
measure: Intensity of Care: Hospital Readmissions (7 Days)
timeFrame: from randomization to 7 days post-discharge
measure: Intensity of Care: Hospital Readmissions 30 Days
timeFrame: from randomization to 30 days post-discharge
measure: Intensity of Care/ICU Use: ICU Free Days (30 Days)
timeFrame: from randomization to 30 days post randomization
measure: Intensity of Care/ICU Use: ICU Free Days (90 Days)
timeFrame: from randomization to 90 days post randomization
measure: Intensity of Care/Hospital Use: Hospital Free Days (30 Days)
timeFrame: from randomization to 30 days post randomization
measure: Intensity of Care/Hospital Use: Hospital Free Days (90 Days)
timeFrame: from randomization to 90 days post randomization
measure: Patient or Surrogate/Family-reported Discussion of Goals
timeFrame: 3-5 days after randomization
measure: Patient or Surrogate/Family-reported Discussion of Goals
timeFrame: 4-6 weeks after randomization
measure: Quality of Communication (QOC)
timeFrame: 3-5 days after randomization
measure: SUPPORT Questions
timeFrame: 3-5 days after randomization
measure: SUPPORT Questions
timeFrame: 4-6 weeks after randomization
Other outcomes:
measure: Intensity of Care: Palliative Care Consults Completed (30 Days)
timeFrame: 30-days post randomization
measure: Intensity of Care: Palliative Care Consults Completed (90 Days)
timeFrame: 90-days post randomization
measure: All-cause Mortality at 30 Days (Safety Outcome)
timeFrame: 30 days after randomization
measure: All-cause Mortality at 120 Days (Safety Outcome)
timeFrame: 120 days after randomization
measure: Goals-of Care Discussions: Time to First Goals of Care Discussion
timeFrame: 30-days post randomization
measure: Anxiety (HADS Subscale)
timeFrame: 4-6 weeks after randomization
measure: Depression (HADS Subscale)
timeFrame: 4-6 weeks after randomization
measure: EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
timeFrame: 4-6 weeks after randomization
measure: CollaboRATE
timeFrame: 3-5 days after randomization
measure: Goal Concordance
timeFrame: 3-5 days after randomization
measure: Goal Concordance
timeFrame: 4-6 weeks after randomization
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: UW Medical Center - Northwest
state: Washington
city: Seattle
country: United States
facility: UW Medical Center - Montlake
state: Washington
Study officials:
affiliation: University of Washington
name: Erin K Kross, MD
role: PRINCIPAL_INVESTIGATOR
References: