2 pages 7hrs please

Name(s): Training Topic: Cushing’s Disease Clinical Trial Nurse Coordinator Training

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Training Diagnosis Plan and Report Template Instructions: If more than one person is working as a group on this assignment, ensure all names appear at the top of this paper. In Step 1 add as many rows as needed for your particular setting. Note that you may not be able to gather all information you list in Step 1 prior to submitting this assignment. Even so, please list all the information you ideally would like to collect. Mention any gaps in Step 2 and indicate if and when such information might be available. If there are such gaps, Step 3 may be a best guess scenario for now, and of course it can be revised if more information comes in before you finish your training guide. If you are not physically present in the location for which the training is designed, you may need to rely on e-mails, Skype calls, documents from the internet and of course your own experiences for information on training needs. 1. Plan for Gathering Training Need Information Audience (e.g. potential trainees, supervisors, community members, the agency staff)

Information Needed Information Collection Method (e.g. interview, pre-test, document review, observation checklist, record review, FGD)*

Role of Potential Trainees (e.g. Training Committee helps design instrument, moderates focus groups)

Endocrinology Clinical Trial Nurse Coordinators

Existing understanding of the approach /steps required in recruiting, screening, enrolling and communicating the details of a research protocol to patients with Cushing’s disease

Advisory Board of clinical trial nurse coordinators, patients, patient advocates

Training Committee helps to develop the advisor board discussion guide and related questions

Endocrinology Clinical Trial Nurse Coordinators

Current understanding of the psychosocial symptoms and factors that affect patients with Cushing’s disease, which may potentially impact patient participation in a clinical trial

Pre- and post-tests to identify and directly measure learning/practice gaps and compare outcomes between the pre- and post-training settings

Training Committee helps to craft the questions and also evaluates/compares the pre- vs post-test findings

Name(s): Training Topic: Cushing’s Disease Clinical Trial Nurse Coordinator Training

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Endocrinology Clinical Trial Nurse Coordinators

Ability to administer a Quality of Life/Patient Reported Outcomes survey to patients as part of the research protocol, without introducing bias

Observation of the trial coordinators administering the questionnaires to patients

Trainers conduct the observation, review and discuss observation findings and provide feedback directly to the trial coordinators for improvement

Endocrinology Clinical Trial Nurse Coordinators

Utilization of a nurse-to- patient checklist to 1) assess patient’s potential participation/eligibility in the research protocol and 2) to facilitate communication between trial coordinators and patients

Observation of the trial coordinators’ utilization of the checklist; interviews of the coordinators with prewritten questions related to ease-of- use of the checklist

Training committee helps to design the checklist and follow-up interview questions. Trainers conduct the actual observation, review and discuss observation findings and provide feedback to the trial coordinators for improvement

Institutional Review Board (IRB)

Approval of the IRB must be sought for all materials related to the research protocol and related training

Group Discussion Training Committee must meet with the IRB and discuss all aspects of the training; all materials related to the protocol (e.g. checklists, Quality of Life questionnaires) and to the training should be submitted to the IRB for review and approval

Trial Investigators To assess understanding of the obligations required and overall support of the trial investigators who are ultimately responsible and accountable for every aspect of the research protocol

Interviews Training Committee meets with Trial Investigators to outline/review/discuss the training plan of action

Name(s): Training Topic: Cushing’s Disease Clinical Trial Nurse Coordinator Training

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*If needed, describe additional details on instrument design, information collection procedures, information processing, information analysis, etc., here  2. Summary of Key Findings (Mention what information is available to date such as from documents or surveys and say what

will be collected later) According to the findings of a recent advisory board conducted in June 2013, trial coordinators identified significant challenges to face when conducting a research protocol in Cushing’s disease that need to be addressed. Particular gaps included:

 Challenges in Cushing’s disease patients’ psychosocial symptoms impacting their potential trial participation  Complicated trial visit schedules require clear explanation to patients

See attached page 4 for additional findings from the advisory board. Additional data to be collected at a later date (TBD) 3. List of Priority Training Needs (You may need to make assumptions for now based on limited available information and

update as you go along)

 Need to train the trial coordinators on the psychosocial symptoms that may impact patients’ emotional status, eligibility and overall participation in a clinical trial

 Need to train the nurse coordinators on how they approach and communication with patients at the recruitment, screening, enrollment and monitoring stages of the research protocol in a health literate, patient friendly method (e.g., clearly explain what is placebo, what is randomization, etc)

 Creation of a nurse-to-patient checklist, along with a calendar template to more clearly describe to the patient expectations and time commitment required

4. Attach sample training needs information collection instruments Note: see page 5 for sample of data collection instrument

Name(s): Training Topic: Cushing’s Disease Clinical Trial Nurse Coordinator Training

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Note to Advisors of Cushing’s Disease Clinical Trial Advisory Board The feedback provided at the June 2013 by patients, patient advocates, caregivers and research nurses on trials involving patients with Cushing’s disease was greatly appreciated. The advice provided important insight for the clinical development team as they move forward with administering the protocol. Key takeaway points for the clinical team included but were not limited to:

 Developing a “doable” visit schedule for patients with Cushing’s disease. o The clinical team is following up to evaluate the time to receive Urine Free Cortisol results from the central lab.

 Consideration of allowing a “window” around visit dates in the protocol.  Consideration for the transportation / travel issues for patients with Cushing’s disease.  Consideration of the time commitment involved by the patient for follow up.  Consideration of the challenges for completing QoL questionnaires when the patient’s focus and attention is challenged

o We have already investigated the possibility of providing a verbal format for QoL questionnaires, but this will not be possible as the tool is validated in written format only.

 Need to develop patient/caregiver materials related to the trial including:  Checklist for research nurses  Calendar template clearly describing the patient expectations  Dear Colleague letter (incl. postage if possible) for the investigator to use to let referring physicians know of the trial  Need to develop patient / caregiver educational materials describing clinical trials

Name(s): Training Topic: Cushing’s Disease Clinical Trial Nurse Coordinator Training

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Sample Discussion Guide Instrument

 What expectation do you have, or what is most important, when considering enrolling a patient with Cushing’s disease in a clinical trial?

 Are there any best practices to share regarding tips and talking points for patients considering taking part in a trial?  Does the reason for conducting the study make sense from a patient’s perspective?  Do you have any concerns about the treatment plans and arms?  What could potentially be an obstacle for patients to stay on the trial until study end?  What might be a patient or advocate’s concerns prior to study entry?  What is the most important aspect that a patient might consider to enroll in the study?  What can we include in the informed consent to better explain the trial to participants?  Any other suggestions to improve understanding of the trial by potential patients?  Do you have suggestions on making the visit assessment more patient-friendly?  Do you foresee any issues with the visit schedule for patients? If yes, please elaborate  Do you believe the visit schedule will be easy to follow for patients? If no, about which visits and/or assessments do you

have concerns?