Education & Mentorship for Advanced Practice Providers in Research

(COACH-APP Trial)

Recruiting at 17 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called COACH-APP, designed to boost the confidence of advanced practice providers (such as nurse practitioners and physician assistants) in conducting clinical research. The program aims to integrate these providers into cancer research teams, potentially enhancing patient care and access to clinical trials. Participants will receive either mentorship and educational resources or only educational resources to determine which approach is more effective. This trial is ideal for APPs currently treating cancer patients who have not participated in specific research workshops or committees. As an unphased trial, it offers APPs a unique opportunity to enhance their research skills and contribute to improving cancer care.

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 prior data suggests that the COACH-APP program is safe for advanced practice providers?

Research has shown that mental health apps, such as those similar to COACH-APP, are generally safe but may pose some risks. A review of these apps found them helpful but noted potential unexpected negative effects for some users. However, the COACH-APP in this trial differs by focusing on educating and mentoring healthcare providers, rather than directly treating mental health issues.

This trial, centered on an educational program rather than a new drug or medical procedure, is considered low-risk. Similar educational programs have not reported major safety concerns. The goal is to support healthcare providers with training, which typically does not cause physical side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COACH-APP intervention because it offers a fresh approach to enhancing the skills of Advanced Practice Providers (APPs) in clinical research. Unlike traditional educational methods, COACH-APP combines a structured workshop with hands-on mentoring over a year, which could lead to a deeper understanding and more effective application of clinical research practices. This dual approach not only equips APPs with valuable knowledge but also provides ongoing support and guidance, potentially transforming how they contribute to research teams. By fostering stronger, more informed care teams, this initiative aims to improve research outcomes and the overall quality of patient care.

What evidence suggests that the COACH-APP program is effective in improving research self-efficacy among advanced practice providers?

Studies have shown that mentorship and education programs can increase confidence and skills. In this trial, the COACH-APP program, provided to participants in Arm I, combines structured mentorship with education to enhance advanced practice providers' (APPs) confidence in their research skills. This could lead to better participation in research, ultimately improving patient care. Similar programs have successfully used coaching to enhance professional skills and involvement in various fields. Early findings suggest that when APPs receive specific support and training, they are more likely to contribute effectively to clinical research teams. This makes COACH-APP a promising way to boost research involvement among APPs. ^{6 7 8 9 10}

Who Is on the Research Team?

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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