Education & Mentorship for Advanced Practice Providers in Research

(COACH-APP Trial)

Overseen By Karen Craver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: SWOG APP workshop, NCORP PI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

97 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

What safety data exists for the Education & Mentorship for Advanced Practice Providers in Research program?

The research articles focus on adverse event reporting systems and practices, but do not provide specific safety data for the Education & Mentorship for Advanced Practice Providers in Research program or COACH-APP. ^{1 2 3 4 5}

What makes the COACH-APP treatment unique compared to other treatments?

The COACH-APP treatment is unique because it focuses on providing education and mentorship to advanced practice providers, enhancing their research skills and leadership in clinical settings. This approach is novel as it combines professional development with mentorship, which is not typically a component of standard treatments for medical conditions. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for nurse practitioners and physician assistants who are part of cancer care teams but not usually involved in research. They must be registered with the NCI, work at a site that participates in NCORP/NCTN trials, have support from their practice to dedicate time to the study, and plan to stay in their current role for at least 12 months.

Inclusion Criteria

I have submitted my supervisor's approval for this study.

I have completed the APP Attestation in the survey.

My practice can support the enrollment for the APP trial as confirmed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Mentorship Intervention

APPs complete the SWOG APP Clinical Research Workshop and receive mentorship sessions over 12 months

12 months

5 mentoring sessions (15-60 minutes each)

Follow-up

Participants are monitored for changes in research self-efficacy and integration into research care teams

12 months

Treatment Details

Interventions

• COACH-APP

Trial Overview The COACH-APP program is being tested to see if it can boost advanced practice providers' confidence in participating in clinical research. It involves education and mentorship aimed at integrating them more effectively into research teams, which could enhance patient care and access to trials.

Participant Groups

Group I: Research Care Team Members Experimental Treatment 1 Intervention

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.

Group II: Mentors Experimental Treatment 2 Interventions

The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.

Group III: Arm I (COACH-APP) Experimental Treatment 4 Interventions

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.

Group IV: Arm II (education control) Active Control 2 Interventions

APPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Integrating adverse event (AE) reporting into a mobile application used by physicians significantly increased AE reporting, with a more than 37-fold rise in reports (from 21 to 806).

The proportion of AE reports submitted by physicians also increased dramatically, from 0.1% to 12% of all reports, highlighting the effectiveness of this integration in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Adverse Event Reporting Into a Free-Text Mobile Application Used in Daily Workflow Increases Adverse Event Reporting by Physicians. Delio, J., Catalanotti, JS., Marko, K., et al.[2021]

A prospective patient registry for neurosurgical procedures, implemented in 2013, successfully captured data from 8226 patients across nearly 12,000 surgeries, highlighting its effectiveness in tracking complications over time.

The Clavien-Dindo grade (CDG) was validated as a reliable method for classifying complications, showing a clear correlation with patient outcomes such as performance status and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Sarnthein, J., Staartjes, VE., Regli, L.[2022]

A systematic review identified 28 studies that reported on 23 different patient-reported instruments for measuring patient safety in primary care, highlighting a significant gap in comprehensive tools for assessing safety from the patient's perspective.

While some instruments demonstrated good psychometric properties, most focused narrowly on specific issues like adverse drug reactions, indicating a need for more robust and comprehensive assessment tools in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring experiences and outcomes of patient safety in primary care: a systematic review of available instruments. Ricci-Cabello, I., Gonçalves, DC., Rojas-García, A., et al.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Integrating Adverse Event Reporting Into a Free-Text Mobile Application Used in Daily Workflow Increases Adverse Event Reporting by Physicians. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Measuring experiences and outcomes of patient safety in primary care: a systematic review of available instruments. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Mentoring advanced practice nurses in research: recommendations from a pilot program. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Developing clinical leaders: the impact of an action learning mentoring programme for advanced practice nurses. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The role of advanced clinical practitioners in clinical research. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

What are the professional development and mentorship needs of advanced practice nurses? [2010]

10. England pubmed.ncbi.nlm.nih.gov

Interventions to support and develop clinician-researcher leadership in one health district. [2018]