Cancer, Chronic Obstructive Pulmonary Disease, Dementia, End-stage Liver Disease, End-stage Renal Disease, Heart Failure, Interstitial Lung Disease, Seriously Ill Patients
Conditions
Keywords
implementation science, primary health care, advance care planning, patient care planning, palliative care, goals of care conversation, serious illness
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.
Interventions
BEHAVIORALClinician Implementation Strategy Stage 1: low intensity clinician training
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.
BEHAVIORALClinician Implementation Strategy Stage 2: high intensity clinician training
This includes two components: 1. Team facilitation to help the primary care team (advance practice provider, nurse, social worker) work together to create roles and responsibilities for accomplishing goals of care conversations with patients 2. A patient list "trigger" of patients potentially eligible for goals of care conversations (the patient study population) will be sent to the primary care clinicians.
BEHAVIORALLow patient engagement
Patients will be sent information about goals of care conversations, including the PREPARE website.
BEHAVIORALHigh patient engagement
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
The primary outcome of goals of care conversation notes is determined by whether notes are entered into the electronic health record. The data manager queries the VA corporate data warehouse to determine if these notes are completed. Because the data manager can see who wrote the notes, the data manager is not blinded. However, the investigators do not expect the data manager to judge whether the notes were completed.
Intervention model description
Sequential multiple-assignment randomized clinical trial (SMART)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 by primary care during Stage 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 by primary care during the study. |
| 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 by primary care during stage 1 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Bekelman, MD MPH
Rocky Mountain Regional VA Medical Center, Aurora, CO
PRINCIPAL_INVESTIGATORAnne M Walling, MD PhD
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Participant flow
Pre-assignment details
"No then no patient engagement" and "Low then no patient engagement" participants were assigned to the other 4 arms in Stage 1 and were meant to receive no patient engagement in Stage 2.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72.1 Years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 109 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 982 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 109 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 29 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 306 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 38 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 82 Participants |
| Race (NIH/OMB) White | 1493 Participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 1117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 33 / 599 | 29 / 560 | 29 / 543 | 32 / 605 | 79 / 244 | 89 / 235 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed