跳至主要内容
临床试验/NCT05322317
NCT05322317已完成不适用

Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP.

研究概览

简要总结

ADVANCE-PC: Aligning Dementia & adVANce Care planning Education in Primary Care, is a communications and implementation support intervention that builds on existing ACP programs, understanding of dementia, and clinical expertise to provide training and technical assistance tailored to the needs of primary care clinicians and clinics that are often over-burdened and under-resourced. For this pilot, we will recruit six primary care clinics to test the ADVANCE-PC delivered using remote technology (ECHO). The pilot will include conducting one ECHO cycle and assessing the feasibility and acceptability of the program content and this mode of delivery (Aim 1) and testing pragmatic outcome assessment for the intervention (Aim 2).

详细描述

Aim 1: To assess the feasibility, acceptability, and content utility of the ECHO program among the clinicians in the participating primary care clinics. Data will be collected to assess successful program implementation and participant engagement. We will document outreach efforts, reporting why clinics decline to participate and as well as the initial motivations of those who agree. Data will be collected from participating clinicians: a pre-training questionnaire about their prior experience with ACP and dementia; feedback at the end of each session; and a longer questionnaire at the end of the training that measures intentions to engage in ACP, their understanding of dementia, their confidence in engaging patients and families in ACP, and what barriers they expect to encounter. Attendance will be documented, and ECHO sessions will be recorded so participation and trainee engagement can be assessed. At the end of the follow-up period, clinicians will participate in interviews focused on barriers to and facilitators of ACP in the context of dementia. Feasibility and acceptability of this intervention will be evaluated using descriptive and qualitative analyses of these data.

Aim 2: To pilot test the ascertainment of outcomes for the ADVANCE-PC program in the 3-month period when trained clinicians are attempting to conduct ACP routinely in their clinics. The primary outcome will be the proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP. To pilot test pragmatic assessment of this outcome, we will work with clinics to determine how the number of patients with dementia seen in a defined period (the denominator) and number who are engaged in ACP (the numerator) can be efficiently identified in by each clinic using their electronic health record (EHR). We will collect information on EHR functionality and current dementia and ACP documentation during Months 1-3 and integrate support for documentation and measurement into the training. Our secondary outcomes are clinician confidence, intentions, and behavior related to ACP. These will be evaluated during the ECHO program using questionnaires modeled after data collection activities routinely used by clinics for quality improvement and formally measured and analyzed using research questionnaires pre and post completion of the ECHO program and a semi structured interview at the end of the follow-up period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinic Level
  • The program will be offered to six primary care clinics. Each must meet the following criteria:
  • Be a member in a practice-based research network (PBRN) within the Meta-network Learning and Research Center (Meta-LARC),
  • Have a functional EHR,
  • Have leadership that agrees to clinic participation, and
  • Is willing to attempt to track and report the number of eligible patients (those with dementia seen in the clinic by program-trained clinicians) and the number of these patients and/or care partners that received ACP from these program-trained clinicians during a 5-month follow-up period.
  • Clinician/Staff Level
  • Within participating clinics, primary care clinicians and other staff must meet all the following inclusion criteria to participate in the training program and the research questionnaire/interview:
  • Willing to participate in ECHO sessions,
  • Willing to work on ACP implementation between sessions, and
  • Be highly likely to have visits with at least 8 patients with dementia and/or their care partners in a 5-month follow-up period.
  • Adults of any age and pregnant people will be allowed to participate. Primary care clinicians and staff will all be over 18 years old and there is no maximum age limit for participation. It is possible that a primary care clinician or staff member who participates may be pregnant. This research does not inquire about pregnancy status and there is no added risk to the fetus in including a pregnant person in professional training.

排除标准

  • Anyone meeting one or more of the exclusion criteria listed here will be excluded. We will exclude:
  • Children and adolescents, as the target population is primary care clinicians, patient care team members, and primary care clinic staff;
  • Clinicians who do not provide primary care;
  • Primary care clinicians who do not care for patients with dementia; and
  • Primary care clinics that do not have sufficient clinicians (6 clinicians or team members) or sufficient patients (at least 8 patients each) with dementia to meet the pilot test targets.
  • There will be no systematic exclusion of participants based on age, gender or race, and/or ethnicity.

结局指标

主要结局

Proportion of patients with dementia and/or their care partners seen by participating clinicians who are engaged in ACP.

时间窗: 8 months after start of program

Primary care clinics will identify: patients with dementia and/or their care partners who have visits with participating clinicians during the study period (denominator) and track the number of these people who are engaged in advance planning during the project period (numerator)

Percentage of enrolled participants who attend 80% of ECHO program sessions

时间窗: 5 months after start of program

number of participants who attended 80% of sessions/number of enrolled participants

次要结局

  • Participating clinician satisfaction rating: questionnaire designed for this study(8 months from start of ECHO program)
  • Percentage of enrolled participants who plan to continue to engage patients with dementia in ACP(8 months after start of program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annette Totten

Associate Professor and Core Investigator of Medical Informatics and Clinical Epidemiology, School of Medicine

Oregon Health and Science University

研究点 (2)

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