- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05596760
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers (PICSI-M)
Hybrid Efficacy-effectiveness Trial to Promote Goals-of-care Discussions for Patients With Alzheimer's Disease and Related Dementias and Their Family Caregivers
Study Overview
Status
Conditions
- Liver Cirrhosis
- Quality of Life
- Neoplasm Metastasis
- Pulmonary Disease, Chronic Obstructive
- Peripheral Vascular Diseases
- Dementia
- Kidney Failure, Chronic
- Chronic Disease
- Lung Diseases, Interstitial
- Health Communication
- Lung Neoplasm
- Heart Failure,Congestive
- Patient Care
- Health Care Quality, Access, and Evaluation
- Palliative Care, Patient Care
- Diabetes With End Organ Damage
- Patient Care Planning
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Nielsen
- Phone Number: 206 744-9516
- Email: eniels9@u.washington.edu
Study Contact Backup
- Name: Janaki M Torrence, MS
- Phone Number: 206 402 7357
- Email: jtorrenc@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Recruiting
- Harborview Medical Center
-
Contact:
- Erin Kross, MD
- Phone Number: 206-744-4649
- Email: ekross@uw.edu
-
Seattle, Washington, United States, 98195
- Recruiting
- UW Medical Center
-
Contact:
- Erin Kross, MD
- Phone Number: 206-744-4649
- Email: ekross@uw.edu
-
Seattle, Washington, United States, 98195
- Recruiting
- UW Medicine Neighborhood Clinics
-
Contact:
- Erin Kross, MD
- Phone Number: 206-744-4649
- Email: ekross@uw.edu
-
Contact:
- Janaki M Torrence, MS
- Phone Number: 206.402.7357
- Email: jtorrenc@uw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Jumpstart Guide
The Jumpstart Guide is developed using automated methods.
It summarizes the presence/absence of POLST, advance directives and DPOA documentation.
The Jumpstart Guide also provides tips for conducting discussion about goals of care.
|
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.
|
No Intervention: Usual Care
Clinicians of patients in the Usual Care arm will not receive a Jumpstart Guide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EHR documentation of Goals of Care discussions
Time Frame: 90 days following randomization
|
The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the EHR in the period by 90 days following randomization.
The proportion is the number of patients with GOC documentation over the number of patients in each study arm.
|
90 days following randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and depression (HADS)
Time Frame: 30 days following randomization.
|
Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS).
The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress.
Seven items evaluate anxiety and seven evaluate depression.
Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21.
|
30 days following randomization.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erin Kross, MD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neurocognitive Disorders
- Disease Attributes
- Liver Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Atherosclerosis
- Neoplastic Processes
- Lung Diseases, Obstructive
- Fibrosis
- Renal Insufficiency, Chronic
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Heart Failure
- Neoplasms
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Lung Neoplasms
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Neoplasm Metastasis
- Liver Cirrhosis
- Dementia
- Kidney Failure, Chronic
- Renal Insufficiency
- Chronic Disease
- Lung Diseases, Interstitial
Other Study ID Numbers
- STUDY00015800
- R01AG078169 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
The Cleveland ClinicRecruiting
-
The Cleveland ClinicRecruitingCirrhosis, LiverUnited States
-
University of PittsburghNational Institute on Drug Abuse (NIDA)CompletedCirrhosis, LiverUnited States
-
Beth Israel Deaconess Medical CenterAmerican Association for the Study of Liver Diseases FoundationCompleted
-
Asian Institute of Gastroenterology, IndiaCompletedCirrhosis, LiverIndia
-
Sherief Abd-ElsalamUnknown
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNWithdrawn
Clinical Trials on Jumpstart Guide
-
University of WashingtonNational Institute on Aging (NIA)CompletedLiver Cirrhosis | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Dementia | Kidney Failure, Chronic | Chronic Disease | Peripheral Vascular Disease | Lung Diseases, Interstitial | Health Communication | Lung Neoplasm | Heart Failure,Congestive | Patient Care | Health Care Quality, Access, and Evaluation and other conditionsUnited States
-
University of WashingtonNational Institute on Aging (NIA)Active, not recruitingLiver Cirrhosis | Quality of Life | Lung Neoplasms | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Dementia | Kidney Failure, Chronic | Chronic Disease | Peripheral Vascular Disease | Lung Diseases, Interstitial | Health Communication | Heart Failure,Congestive | Patient Care | Health Care Quality... and other conditionsUnited States
-
University of WashingtonCompletedDiabetes Complications | Renal Insufficiency, Chronic | Dementia | Leukemia, Lymphocytic, Chronic, B-Cell | Peripheral Vascular Disease | Frail Elderly | Congestive Heart Failure | Malignant Neoplasm | Lung Disease Chronic | Liver Failures, ChronicUnited States
-
Hamilton Health Sciences CorporationMcMaster University; Edwards LifesciencesRecruitingAortic Valve Stenosis | Transcatheter Aortic Valve ReplacementCanada
-
University of ConnecticutNational Institute of Mental Health (NIMH)Completed
-
University of WashingtonRecruiting
-
University of MichiganArthrex, Inc.CompletedShoulder Pain | Shoulder Osteoarthritis | Shoulder Arthritis | Shoulder Arthropathy Associated With Other ConditionsUnited States
-
Cairo UniversityUnknownEndodontic Disease | Endodontic Re-treatment Failure
-
Cairo UniversityUnknown
-
Xiamen Cardiovascular Hospital, Xiamen UniversityRecruiting