Cancer Clinical Trial
— LSTDIOfficial title:
Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness
Verified date | January 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.
Status | Enrolling by invitation |
Enrollment | 72 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Ha DM, Deng LR, Lange AV, Swigris JJ, Bekelman DB. Reliability, Validity, and Responsiveness of the DEG, a Three-Item Dyspnea Measure. J Gen Intern Med. 2022 Aug;37(10):2541-2547. doi: 10.1007/s11606-021-07307-1. Epub 2022 Jan 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of patients with a goals of care conversation note documented in Stage 2 | 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 | Percent of patients with a goals of care conversation note documented in Stage 1 or 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 | |
Secondary | Percent of patients with a goals of care conversation note documented in Stage 1 | 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) |
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