Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HX002935 | Other Identifier | eRA Project Ref |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No then high patient engagement | Active Comparator | 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. |
|
| No then low patient engagement | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician Implementation Strategy Stage 1: low intensity clinician training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percent of patients with a goals of care conversation note documented in Stage 1 |
Not provided
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
Exclusion Criteria:
PATIENTS
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States | ||
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34981344 | Background | 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. | |
| 39254148 | Background | Haverfield MC, Ma J, Walling A, Bekelman DB, Brown-Johnson C, Lo N, Lorenz KA, Giannitrapani KF. Communication processes in an advance care planning initiative: A socio-ecological perspective for service evaluation. Palliat Med. 2024 Dec;38(10):1134-1143. doi: 10.1177/02692163241277394. Epub 2024 Sep 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2025 | |
| Reset | Jan 12, 2026 |
Not provided
Sequential multiple-assignment randomized clinical trial (SMART)
Not provided
Not provided
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.
| Low then low patient engagement | Active Comparator | 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. |
|
|
| Clinician Implementation Strategy Stage 2: high intensity clinician training | Behavioral | This includes two components:
|
|
| Low patient engagement | Behavioral | Patients will be sent information about goals of care conversations, including the PREPARE website. |
|
|
| High patient engagement | Behavioral | 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. |
|
|
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) |
| West Los Angeles |
| California |
| 90073-1003 |
| United States |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | United States |
| 39074531 | Result | Bekelman DB, Giannitrapani K, Linn KA, Langner P, Sudore RL, Rabin B, Lorenz KA, Foglia M, Glickman A, Pawlikowski S, Sloan M, Gamboa RC, McCaa MD, Hines A, Walling AM. Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial. Contemp Clin Trials. 2024 Oct;145:107643. doi: 10.1016/j.cct.2024.107643. Epub 2024 Jul 27. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2025 | Jan 12, 2026 | |||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006333 | Heart Failure |
| D017563 | Lung Diseases, Interstitial |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007676 | Kidney Failure, Chronic |
| D058625 | End Stage Liver Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided