Trial Title:
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
NCT ID:
NCT05596760
Condition:
Dementia
Chronic Disease
Neoplasm Metastasis
Lung Neoplasm
Pulmonary Disease, Chronic Obstructive
Heart Failureļ¼Congestive
Liver Cirrhosis
Kidney Failure, Chronic
Lung Diseases, Interstitial
Peripheral Vascular Diseases
Diabetes With End Organ Damage
Palliative Care, Patient Care
Health Care Quality, Access, and Evaluation
Patient Care
Health Communication
Patient Care Planning
Quality of Life
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Lung Neoplasms
Liver Cirrhosis
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Dementia
Renal Insufficiency
Kidney Failure, Chronic
Heart Failure
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Chronic Disease
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Jumpstart Guide
Description:
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.
Arm group label:
Jumpstart Guide
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
PATIENTS
Inclusion Criteria:
- Be cared for as an outpatient at a UW Medicine clinic
- 55 years of age or older
- Have an ICD-10 code for ADRD documented in the EHR within the prior two years
If patients are cared for in a primary care setting within UW Medicine or by a
geriatrician or neurologist, only a diagnosis of ADRD is required for eligibility.
If patients have ADRD and are not followed by a primary care clinician at UW Medicine but
are followed by a subspecialist, eligible patients must also have an ICD-10 code for one
or more of seven chronic conditions used by the Dartmouth Atlas, relevant for the
specialist they see, to ensure that goals-of care discussions are applicable for these
specialists in the care of the enrolled patient. These conditions by specialist are:
malignant cancer/leukemia (oncologist), chronic pulmonary disease (pulmonologist),
coronary artery disease or heart failure (cardiologist), chronic liver disease
(hepatologist), chronic renal disease (nephrologist), and diabetes with end-organ damage
(endocrinologist).
Exclusion Criteria:
- restricted status, legal or risk management concerns
- without capacity to complete informed consent procedures and without a legal
surrogate to enroll them (for the survey component or qualitative interviews)
- non-English speaking (for the survey component or qualitative interviews)
FAMILY MEMBERS
Inclusion Criteria:
- Identified (via the patient or the EHR) as the person most involved in care for an
eligible patient in the trial
- 18 years of age or older
- English language proficiency
Exclusion Criteria:
- legal or risk management concerns
- psychological illness or morbidity preventing completion of study materials
- physical or mental limitations preventing completion of study materials
- non-English speaking
Not all patients will have an eligible family member to enroll.
CLINICIANS
Inclusion Criteria:
- Physician or advance practice provider caring for older adults within UW Medicine
clinics
- 18 years of age or older
- English language proficiency
- (Interviews) Identified as clinician of record for an enrolled patient in the trial
and received a Jumpstart guide
Exclusion Criteria:
- legal or risk management concerns
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Harborview Medical Center
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Kross, MD
Phone:
206-744-4649
Email:
ekross@uw.edu
Facility:
Name:
UW Medical Center
Address:
City:
Seattle
Zip:
98195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Kross, MD
Phone:
206-744-4649
Email:
ekross@uw.edu
Facility:
Name:
UW Medicine Neighborhood Clinics
Address:
City:
Seattle
Zip:
98195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Kross, MD
Phone:
206-744-4649
Email:
ekross@uw.edu
Start date:
September 11, 2023
Completion date:
July 2027
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596760
