Clinical trial NCT05001009: Goals of Care Conversations Study
Official title: Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Seriously Ill Patients
Cancer
Heart Failure
Interstitial Lung Disease
Chronic Obstructive Pulmonary Disease
End-stage Renal Disease
End-stage Liver Disease
Dementia
Keywords: implementation science
primary health care
advance care planning
patient care planning
palliative care
goals of care conversation
serious illness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential multiple-assignment randomized clinical trial (SMART)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of patients with a goals of care conversation note documented in Stage 2
timeFrame: From the start of stage 2 to 9 months later
Secondary outcomes:
measure: Percent of patients with a goals of care conversation note documented in Stage 1 or 2
timeFrame: From the start of stage 1 to 9 months after the start of stage 2
measure: Percent of patients with a goals of care conversation note documented in Stage 1
timeFrame: From the start of stage 1 to the beginning of stage 2 (approximately 8 months)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: David Bekelman, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Anne M Walling, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.