9930 HTC Train-the-Trainer, Change Guide

HTC care teams preparing to integrate a new therapy into the care of patients with hemophilia can use this change guide to ensure HTC readiness. Included below are key topics and relevant questions that need to be addressed to prepare for and integrate new therapies.

Change areas included in this guide are:
a)   Patient eligibility
b)   Referral to centers offering treatment
c)   Patient preparation
d)   Treatment delivery
e)   Post-administration management
f) Providing patient support
g)   Care coordination
h)   Assessing laboratory measurements of coagulation when using novel agents

Once you’ve explored the questions and the current status within your HTC, work as a team or alone to develop a specific action plan to implement change.

To facilitate the process of integrating a new treatment, this guide has 6 steps dedicated to each of these high level topics, with a set of relevant questions that need to be addressed to ensure HTC readiness. Your responses will not be shared with anyone besides yourself and your team and will remain anonymous.

Step 1: Select Change Area
Step 2: Discuss questions, identifying any additional information your team may need to answer the questions for your HTC and its patients
Step 3: Determine necessary changes to integrate new therapy
Step 4: Outline concrete steps needed to implement changes
Step 5: Identify existing systems and resources to leverage to successfully make changes
Step 6: Determine potential barriers to change and how the team might address those barriers

Step 1: Change Area

1. Select the Change Areas your or your HTC care team will focus on

Patient eligibility
Referral to centers offering treatment
Patient preparation
Treatment delivery
Post-administration management
Providing patient support
Care coordination
Assessing laboratory measurements of coagulation when using novel agents

2. Identify which new therapy you or your HTC care team will focus on

Step 2: Discuss questions, identifying any additional information you or your team may need to answer the questions from your HTC and its patients

Patient eligibility:
Identifying Patients Eligible and Appropriate for New Therapies

3. Based on inclusion/exclusion criteria from clinical trials and label indication, which patients will be eligible for treatment? (Work from list of inclusion/exclusion criteria for new treatment) *This question is required.

3. Based on the current status of patient (disease severity, frequency of bleeds, frequency of infusions, impact on quality of life, etc), is a change in treatment appropriate? *This question is required.

Referral to centers offering treatment:
Referring Patients to Treatment Centers Where New Therapy Is Available (If Treatment Will Not be Available in Local HTC)

3. What information will be needed for making a referral? *This question is required.

3. How will information be communicated (EHR)?
*This question is required.

Patient Preparation:
Preparing Patients for New Therapy

3. What is considered optimal patient care in the days/weeks/months leading up to the switch to a new therapy? *This question is required.

3. Is there any pre-switch medication that needs to be administered? *This question is required.

3. If yes, list medications

3. Does the new therapy interact/interfere with vaccinations (seasonal or otherwise)? *This question is required.

3. Do patients need to be currently on prophylaxis treatment to be considered for the new therapy? *This question is required.

Treatment delivery:
Administration of New Therapies

3. Are the storage requirements clearly defined and present/achievable in your HTC? *This question is required.

3. Is your center currently capable of providing the biosafety level needed for the new therapy (eg, biosafety level 1 for gene therapy, see NIH AAV vector risk group guidance)? *This question is required.

3. Is appropriate training available for all staff members who will be handling the new product? *This question is required.

3. What specific monitoring (if any) is required during and immediately following administration of the new therapy? *This question is required.

3. Is the HTC pharmacy trained and prepared for the new therapy (receipt, handling, storage, etc)? *This question is required.

3. Are emergency measures in place in case of infusion reaction (physician, crash cart, etc)? *This question is required.

3. If yes, what emergency measures are in place?

Post-administration management:
Post-administration Care

Short-term monitoring

3. What is the duration of short-term monitoring immediately following the first treatment (inpatient or outpatient?) What needs to be monitored? *This question is required.

Long-term monitoring (safety and efficacy)

3. What is the recommended frequency for long-term monitoring? *This question is required.

3. What assessments need to be performed? *This question is required.

3. Are the specific requirements for the laboratory assessments associated with the new therapy? *This question is required.

3. If yes, list requirements for laboratory assessments

3. What is the treatment plan for acute bleeds with the new therapy? *This question is required.

Providing Patient Support

3. What additional support will patients need before, during, and after treatment? *This question is required.

Patient support (main concerns, effects on identification as a PWH)
Patient education
Treatment options
Comparison with current treatment
Selection criteria
Known and unknown risks and benefits
Post-treatment expectations
Importance of long-term monitoring

Care coordination:
Coordinating Care Among HTC Care Team Members

3. Will the current system/process for coordination of patient care work for the new therapy? If not, how will it need to be modified? *This question is required.

3. If not, how will it need to be modified?

3. Will EHR forms need to be updated and/or modified for the new therapy? *This question is required.

3. If yes, how so?

Assessing Laboratory Measurements of Coagulation when using Novel Agents

3. Will the new therapy require new methods of assessing coagulation? *This question is required.

3. Are resources available at your HTC to integrate new testing measures? *This question is required.

3. Will samples need to be sent out for testing? If so, how will this be accomplished and by whom? *This question is required.

3. If so, how will this be accomplished and by whom?

Integrating Research Questions Into Clinical Practice

3. Is there an existing list or a list in development of relevant research questions? *This question is required.

3. Is there a process for integrating research questions into the HTC clinical practice? *This question is required.

3. Is there a group or person within the HTC responsible for promoting and monitoring this integration activity? *This question is required.

Step 3: Determine necessary changes to integrate new therapy

3. Determine necessary changes to integrate new therapy

Step 4: Outline concrete steps needed to implement changes

4. Outline concrete steps needed to implement changes

Step 5: Identify existing systems and resources to leverage to successfully make changes

5. Identify existing systems and resources to leverage to successfully make changes

Step 6: Determine potential barriers to change and how the team might address those barriers

6. Determine potential barriers to change and how the team might address those barriers

7. Please enter your email, a copy of your Change Guide will be sent to this address: *This question is required. This question requires a valid email address.