Building Capacity Within the NCORP Network Through an Education and Mentorship Intervention for Advanced Practice Providers (COACH-APP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 97
- 试验地点
- 52
- 主要终点
- Research self-efficacy (RSE)
研究概览
简要总结
This clinical trial evaluates whether a mentorship and education intervention called COACH-APP works to improve advanced practice providers' (APPs) confidence in their ability to participate in clinical research (research self-efficacy). APPs are skilled clinicians who are routinely part of cancer care teams, but who may not routinely be part of the research care team at community oncology sites. The COACH-APP program provides focused education and structured mentorship to assist in meaningful integration to the research care team, which may increase research self-efficacy among APPs and ultimately improve patient care and access to clinical trials.
详细描述
PRIMARY OBJECTIVE:
I. To compare change in research self-efficacy (RSE) scores from baseline to end of study (12 months post-randomization) between APPs in the COACH-APP intervention compared to the education control.
SECONDARY OBJECTIVES:
I. To compare National Cancer Institute (NCI) Community Oncology Research Program (NCORP) engagement post-study (12-months) for APPs in the COACH-APP intervention compared to the education control.
II. To compare changes from baseline to post-study in APP ratings of research care team integration (Assessment for Collaborative Environments [ACE]-15) between the COACH-APP intervention and education control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •APP PRACTICE: Must have one practicing APP who can dedicate approximately 2 hours/month to participate in the intervention and study activities over a 12-month period, supported by their direct supervisor via the APP Support Statement
- •APP PRACTICE: Must attest to research infrastructure that can support APP trial enrollment, as declared on the APP Practice Attestation
- •APP PRACTICE: Must have submitted the APP Practice Attestation within the Study Interest Survey
- •APP PRACTICE: Must have received the required APP practice ID for Oncology Patient Enrollment Network (OPEN) enrollment in the Study Selection Email prior to enrollment
- •APP PRACTICE: Must enroll eligible practice site(s) in OPEN within 14 days of receiving the Study Selection Email.
- •APP: Practicing nurse practitioner (NP) or physician assistant (PA) registered as an active non-physician investigators (NPIVR) within the National Cancer Institute (NCI) Registration and Credential Repository (RCR)
- •APP: Treats oncology patients at practice that is actively recruiting to NCORP and/or NCTN trials
- •APP: Not planning to leave their clinical position within the APP practice (defined as one or more NCORP affiliate or sub-affiliate site[s] where the APP participating in the study sees patients and clinical research activities occur) in the next 12 months at enrollment
- •APP: Willing to participate in a 30-minute recorded phone interview, if selected
- •APP: Completed and submitted the APP Attestation within the Study Interest Survey
- •APP: Completed and submitted an APP Support Statement from their direct supervisor approving participation in this study, within the Study Interest Survey
- •APP: Identify and obtain signed Research Care (RC) Team Acknowledgements from two members (defined below) of their research care team to assist them in this study. The RC team for this study will consist of an oncologist and clinical research professional (i.e., clinical research coordinator, clinical research associate clinical research nurse, etc.) that the APP collaborated with over the past 6 months or could collaborate with in the future to enroll patients on NCORP and/or NCTN trials
- •APP: Must have received the required APP practice ID for OPEN enrollment in the Study Selection Email
- •APP: Must enroll consented APPs in OPEN within 14 days of receiving the Study Selection Email
- •MENTOR: Must be a practicing APP chosen by the WF-2403 COACH-APP Study MPIs
- •MENTOR: Must have the following criteria:
- •Clinical practice experience in a practice that enrolls to NCORP and/or NCTN trials.
- •Participation in a leadership role within NCTN or NCORP (i.e., serving on a Research Base committee, working group, taskforce or as a site PI)
- •Willing to complete COACH-APP mentor training.
- •Willing to complete a 30-minute recorded phone interview about their experience with the COACH-APP intervention
- •RESEARCH CARE TEAM INTERVIEW: Must be an identified member of the Research Care Team for an APP assigned to the COACH-APP intervention arm. The Research Care Team will be reviewed by the APP in the 12 month survey for any changes
- •RESEARCH CARE TEAM INTERVIEW: Willing to participate in a recorded phone interview (approximately 30 minutes) to assess their perceptions of the COACH-APP intervention, including feasibility, acceptability, and impact
排除标准
- •APP PRACTICE: APP practice has an APP serving as a COACH-APP intervention mentor
- •APP PRACTICE: Another APP at the same APP practice is already enrolled in this study (i.e., only 1 APP is allowed per APP practice)
- •APP PRACTICE: Affiliate/sub-affiliate site(s) within this APP practice are already enrolled or are intended to be enrolled in this study under another APP practice
- •APP: Has already completed the SWOG APP workshop
- •APP: Served as a site principal investigator (PI) for an NCORP or NCTN study at any time
- •APP: Participated as a presenter for the SWOG APP workshop
- •APP: Participated on the planning committee for The Advanced Practice Provider Clinical Trials Research Manual
- •APP: Participated on the planning committee for the SWOG APP workshop
- •APP: Past or current member of SWOG APP Task Force Committee
- •APP: Past or current member of Eastern Cooperative Oncology Group- American College of Radiology Imaging Network (ECOG-ACRIN) APP Committee
- •MENTOR: Must not work at NC002-Wake Forest University Health Sciences or its affiliate/subaffiliate sites
研究组 & 干预措施
Mentors
The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.
干预措施: Survey Administration (Other)
Arm I (COACH-APP)
APPs complete the SWOG APP Clinical Research Workshop, consisting of 6 modules, over 2 hours and receive The Advanced Practice Provider Clinical Trials Research Manual. APPs also complete 5 mentoring sessions, over 15-60 minutes each, over 12 months.
干预措施: Survey Administration (Other)
Mentors
The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.
干预措施: Interview (Other)
Research Care Team Members
20 Research Care Team Members will also be enrolled in the study to participate in qualitative interviews to assess their perceptions of the COACH-APP intervention.
干预措施: Interview (Other)
Arm I (COACH-APP)
APPs complete the SWOG APP Clinical Research Workshop, consisting of 6 modules, over 2 hours and receive The Advanced Practice Provider Clinical Trials Research Manual. APPs also complete 5 mentoring sessions, over 15-60 minutes each, over 12 months.
干预措施: Educational Intervention (Other)
Arm I (COACH-APP)
APPs complete the SWOG APP Clinical Research Workshop, consisting of 6 modules, over 2 hours and receive The Advanced Practice Provider Clinical Trials Research Manual. APPs also complete 5 mentoring sessions, over 15-60 minutes each, over 12 months.
干预措施: Behavioral Intervention (Other)
Arm I (COACH-APP)
APPs complete the SWOG APP Clinical Research Workshop, consisting of 6 modules, over 2 hours and receive The Advanced Practice Provider Clinical Trials Research Manual. APPs also complete 5 mentoring sessions, over 15-60 minutes each, over 12 months.
干预措施: Interview (Other)
Arm II (education control)
APPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months.
干预措施: Educational Intervention (Other)
Arm II (education control)
APPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months.
干预措施: Survey Administration (Other)
结局指标
主要结局
Research self-efficacy (RSE)
时间窗: From baseline to 12 months post-randomization
RSE score is calculated as sum of the 22-items measured on a 5-point Likert scale. Will be compared between the COACH-APP intervention and education control arms using a two-sample t-test.
次要结局
- National Cancer Institute Community Oncology Research Program (NCORP) engagement(At 12 months post randomization)
- Change in research care team integration(From baseline to 12 months post randomization)
- Perceptions of feasibility of the COACH-APP intervention(Day 1 (At time of interview))
- Perceptions of acceptability of the COACH-APP intervention(Day 1 (At time of interview))
- Practice-level NCORP and National Clinical Trials Network (NCTN) study activity(Up to 24 months)
- Acceptability of COACH-APP intervention (COACH-APP arm only)(At 12 months)
- Perceptions of appropriateness of the COACH-APP intervention(Day 1 (At time of interview))
- Potential effects of the COACH-APP intervention on the research care team functioning and environment(Day 1 (At time of interview))
- Potential effects of the COACH-APP intervention on patient care quality and access to clinical trials(Day 1 (At time of interview))
- Feasibility of COACH-APP intervention (COACH-APP arm only)(At 12 months)
- Appropriateness of COACH-APP intervention (COACH-APP arm only)(At 12 months)
- Practice-level barriers and facilitators of APP engagement in research activities(Day 1 (At time of interview))