Goals of Care Conversations Study

Официальное название

Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Clinician 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.
• Поведенческое Clinician 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.
• Поведенческое Low patient engagement
  Patients will be sent information about goals of care conversations, including the PREPARE website.
• Поведенческое High 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.

Первичные конечные точки

• Percent of patients with a goals of care conversation note documented in Stage 2 [Срок оценки: From the start of stage 2 to 9 months later]

Вторичные конечные точки (2)

• Percent of patients with a goals of care conversation note documented in Stage 1 or 2 [Срок оценки: 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 [Срок оценки: From the start of stage 1 to the beginning of stage 2 (approximately 8 months)]

Критерии участия

Критерии включения

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

Критерии исключения

PATIENTS

• Prisoner
• Pregnant
• under 18 years of age.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 3 центра

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora

Публикации

• 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. PMID 34981344
• 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. PMID 39254148
• 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. PMID 39074531

Идентификаторы

NCT: NCT05001009 · IIR 19-018 · HX002935

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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