- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001009
Goals of Care Conversations Study (LSTDI)
Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness
Study Overview
Status
Conditions
Detailed Description
The aims of this study are as follows:
Aim 1. Use a clinician-level SMART in three VA health systems to determine the effectiveness of clinician and patient implementation strategies to improve the occurrence of documented goals of care conversations in Veterans with serious medical illness. Hypothesis 1 (first stage of the SMART): Compared to a low intensity clinician strategy alone, a low intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Hypothesis 2. Among those who do not respond to low intensity strategies, compared to a high intensity clinician strategy paired with a low intensity patient strategy, a high intensity clinician and patient strategy will lead to increased documentation of goals of care conversations.
Aim 2a. Identify the sequence of implementation strategies that leads to the overall greatest increase in documentation of goals of care conversations. Aim 2b (exploratory). Identify patient and clinician characteristics that modify the effect of sequences of implementation strategies on documentation of goals of care conversations.
Aim 3. Understand clinician and patient implementation strategy success or failure using a mixed method evaluation involving clinicians, leaders, patients, and caregivers.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
-
West Los Angeles, California, United States, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
CLINICIANS VA primary care advance practice clinicians (MDs, APRNs, PAs) at one of the three study sites able to complete goals of care conversation notes and orders. Advance practice clinicians will be eligible for randomization if they have at least 15 eligible patients without goals of care conversation notes at the start of stage 1 (to allow participating clinicians ample opportunities to write notes) and have written fewer than 4 goals of care conversation notes in the previous 6 months (to select clinicians who need improvement), and can potentially receive the planned implementation strategies, i.e., clinicians who regularly attend the Patient Aligned Care Team (PACT) team meetings.
PATIENTS
- Veteran enrolled in VHA health care in one of the three study sites who is a current patient of one of the eligible primary care clinicians
- Diagnosis of cancer, heart failure, interstitial lung disease, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease, and dementia
- Care Assessment Need score of > or equal to 90 using the one-year combined hospitalization/mortality variable
Exclusion Criteria:
PATIENTS
- Prisoner
- Pregnant
- under 18 years of age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No then high patient engagement
First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training. |
Patients will be sent information about goals of care conversations, including the PREPARE website.
Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.
Other Names:
A "booster" of the established LSTDI implementation strategy.
Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study.
Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
This includes two components:
|
Active Comparator: No then low patient engagement
First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training. |
Patients will be sent information about goals of care conversations, including the PREPARE website.
Other Names:
A "booster" of the established LSTDI implementation strategy.
Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study.
Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
This includes two components:
|
Active Comparator: Low then high patient engagement
First stage: Low intensity patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training. |
Patients will be sent information about goals of care conversations, including the PREPARE website.
Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.
Other Names:
Patients will be sent information about goals of care conversations, including the PREPARE website.
Other Names:
A "booster" of the established LSTDI implementation strategy.
Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study.
Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
This includes two components:
|
Active Comparator: Low then low patient engagement
First stage: Low patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training. |
Patients will be sent information about goals of care conversations, including the PREPARE website.
Other Names:
A "booster" of the established LSTDI implementation strategy.
Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study.
Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
This includes two components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients with a goals of care conversation note documented in Stage 2
Time Frame: From the start of stage 2 to 9 months later
|
Amongst patients attributed to a clinician who was randomized in Stage 2, whether or not a goals of care conversation note was written during Stage 2.
|
From the start of stage 2 to 9 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients with a goals of care conversation note documented in Stage 1 or 2
Time Frame: From the start of stage 1 to 9 months after the start of stage 2
|
Amongst all patients in the study, whether or not a goals of care conversation note was written during the study.
|
From the start of stage 1 to 9 months after the start of stage 2
|
Percent of patients with a goals of care conversation note documented in Stage 1
Time Frame: From the start of stage 1 to the beginning of stage 2 (approximately 8 months)
|
Amongst all patients in the study, whether or not a goals of care conversation note was written during stage 1
|
From the start of stage 1 to the beginning of stage 2 (approximately 8 months)
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
- Principal Investigator: Anne M Walling, MD PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publications and helpful links
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Pathologic Processes
- Respiratory Tract Diseases
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Liver Diseases
- End Stage Liver Disease
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Kidney Failure, Chronic
- Lung Diseases, Interstitial
Other Study ID Numbers
- IIR 19-018
- HX002935 (Other Identifier: eRA Project Ref)
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
product manufactured in and exported from the U.S.
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.
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