Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Percent of patients with a goals of care conversation note documented in Stage 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •under 18 years of age.
结局指标
主要结局
Percent of patients with a goals of care conversation note documented in Stage 2
时间窗: 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.
次要结局
- 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))
- 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)