Malignant NeoplasmPICSI-PNCT03746392
Project to Improve Communication About Serious Illness - Pilot Study
A study testing Jumpstart Intervention in people with Malignant Neoplasm and Leukemia, Lymphocytic, Chronic, B-Cell, run by University of Washington at 2 sites in United States.
Trial summary
This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic
- What is being tested?
- Jumpstart Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- involved in the care of an eligible patient as the legal next-of-kin
- English-speaking
Who cannot join
- unable to complete informed consent procedures and do not have a legal next of kin
- restricted information status (e.g. prisoners)
- pregnant
- unable to complete informed consent procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harborview Medical Center
Seattle, Washington, 98104
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication
This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this communication. Jumpstart forms will also be provided to patients or, if they are unable to communicate, their surrogates/family members. The information on the form will be obtained from questionnaires. The form is tailored to help patients and surrogates talk with clinicians about goals of care. This study is based on a successful application of Jumpstart Form in the outpatient clinic setting.
- Conditions
- Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic, Congestive Heart Failure, Liver Failures, Chronic, Renal Insufficiency, Chronic
- Being tested
- Jumpstart Intervention
- Medical subject headings
- Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Heart Failure, End Stage Liver Disease, Renal Insufficiency, Chronic, Dementia, Diabetes Complications, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumpstart InterventionBehavioural
The intervention has 4 steps: use electronic medical record (EHR) to identify seriously ill, hospitalized patients with no documentation of a goals-of-care (GOC) discussion during their current admission; the enrolled patient or his/her surrogate completes a survey assessing preferences for discussions about GOC, barriers to having such discussions, and current GOC which is used to create a "Jumpstart" form designed to prompt and guide a GOC discussion between the patient or surrogate and the clinicians caring for the patient; use natural language processing/machine learning (NLP/ML) approach to identify GOC discussions or advance directives in the EHR that occurred prior to admission and include this information on the Jumpstart form; and, deliver the Jumpstart form to the primary clinician team. The patient or surrogate is also provided with a version of the form.
| Study group | Role | What they receive |
|---|---|---|
| Jumpstart Intervention | Experimental | Not described Receives: Behavioral: Jumpstart Intervention |
| Usual Inpatient Hospital Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of Goals of Care
Presence of documentation of goals of care discussions in the patient's electronic health record during the index hospitalization
Measured: At hospital discharge, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Engelberg, University of Washington
- Investigators
- Ruth Engelberg, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746392
- Sponsor's protocol ID
- STUDY00004821
- Acronym
- PICSI-P
- Status last verified
- Aug 2025
- First submitted
- 9 Nov 2018
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee RY, Kross EK, Downey L, Paul SR, Heywood J, Nielsen EL, Okimoto K, Brumback LC, Merel SE, Engelberg RA, Curtis JR. Efficacy of a Communication-Priming Intervention on Documented Goals-of-Care Discussions in Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e225088. doi: 10.1001/jamanetworkopen.2022.5088.
PubMed 35363271
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication
- ClinicalTrials.gov ID
- NCT03746392
- Acronym / sponsor ID
- PICSI-P / STUDY00004821
- Conditions
- Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic, Congestive Heart Failure, Liver Failures, Chronic, Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this communication. Jumpstart forms will also be provided to patients or, if they are unable to communicate, their surrogates/family members. The information on the form will be obtained from questionnaires. The form is tailored to help patients and surrogates talk with clinicians about goals of care. This study is based on a successful application of Jumpstart Form in the outpatient clinic setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jumpstart Intervention | Experimental | Behavioral: Jumpstart Intervention |
| Usual Inpatient Hospital Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- involved in the care of an eligible patient as the legal next-of-kin
- English-speaking
Key exclusion criteria (4 listed)
- unable to complete informed consent procedures and do not have a legal next of kin
- restricted information status (e.g. prisoners)
- pregnant
- unable to complete informed consent procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jumpstart InterventionThe intervention has 4 steps: use electronic medical record (EHR) to identify seriously ill, hospitalized patients with no documentation of a goals-of-care (GOC) discussion during their current admission; the enrolled patient or his/her surrogate completes a survey assessing preferences for discussions about GOC, barriers to having such discussions, and current GOC which is used to create a "Jumpstart" form designed to prompt and guide a GOC discussion between the patient or surrogate and the clinicians caring for the patient; use natural language processing/machine learning (NLP/ML) approach to identify GOC discussions or advance directives in the EHR that occurred prior to admission and include this information on the Jumpstart form; and, deliver the Jumpstart form to the primary clinician team. The patient or surrogate is also provided with a version of the form. | Behavioural | Jumpstart Intervention |
Primary outcome
Documentation of Goals of Care
Time frame: At hospital discharge, an average of 2 weeks
Presence of documentation of goals of care discussions in the patient's electronic health record during the index hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35363271Lee RY, Kross EK, Downey L, Paul SR, Heywood J, Nielsen EL, Okimoto K, Brumback LC, Merel SE, Engelberg RA, Curtis JR. Efficacy of a Communication-Priming Intervention on Documented Goals-of-Care Discussions in Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e225088. doi: 10.1001/jamanetworkopen.2022.5088.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Engelberg, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jumpstart Intervention in people with Malignant Neoplasm and Leukemia, Lymphocytic, Chronic, B-Cell, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of Goals of Care (time frame: At hospital discharge, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.