Goals of Care Conversations Study
- Conditions
- End-stage Renal DiseaseSeriously Ill PatientsCancerChronic Obstructive Pulmonary DiseaseInterstitial Lung DiseaseHeart FailureDementiaEnd-stage Liver Disease
- Interventions
- Behavioral: Low patient engagementBehavioral: High patient engagement
- Registration Number
- NCT05001009
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 72
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
PATIENTS
- Prisoner
- Pregnant
- under 18 years of age.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Low then low patient engagement 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. No then low patient engagement 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. Low then high patient engagement Low 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. Low then high patient engagement 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. No then high patient engagement 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.
- Primary Outcome Measures
Name Time Method Percent of patients with a goals of care conversation note documented in Stage 2 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.
- Secondary Outcome Measures
Name Time Method Percent of patients with a goals of care conversation note documented in Stage 1 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
Percent of patients with a goals of care conversation note documented in Stage 1 or 2 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.
Trial Locations
- Locations (3)
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, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
🇺🇸Aurora, Colorado, United States