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.