Domain Expert Working Session

Domain Expert Working Session October 27-28, 2010

caBIG Clinical Information Suite CHEMOTHERAPYPLANNING

Overview • Chemotherapy Planning • Use Cases/Narratives • Data Content • Next Steps

Use Cases / Narratives • Main Use Cases • Create Chemotherapy Plan • This includes all the steps involved in creating a treatment plan for chemotherapy • Update Chemotherapy Plan • This covers any changes to the chemotherapy plan beyond the original creation process

Use Cases / Narratives (cont’d) • Create Chemotherapy Plan • Retrieve Patient Information • Initiate Chemotherapy Plan • Manage Chemotherapy Options • Generate Patient Education Materials • Approve Proposed Medication Plan • Notify Providers about Treatment Plan

Use Cases / Narratives (cont’d) • Retrieve Patient Information • Dr. Tumor checks to make sure that she has this most up-to-date clinical information available for Eve Everywoman. She can see the treatment plan sent from Dr. Cutter sent as part of the referral, as well as a patient summary including the problem list, diagnostic test results, medication list, and medication allergy list. Along with the treatment plan and patient summary the referral included an “Oncologic History” started for Mrs. Everywoman, sorting out contents of her health record relevant to her cancer diagnosis and treatment, such as: staging information, mammogram and ultrasounds images and reports, pathology reports, and clinical notes. Dr. Tumor is satisfied that information available is current so she can begin a treatment plan.

Use Cases / Narratives (cont’d) • Initiate Chemotherapy Plan • Dr. Tumor begins creating a new treatment plan for Mrs. Everywoman that will be part of Eve’s overall care plan. Mrs. Everywoman’s demographic information is placed on the new treatment plan and all of the information currently available (surgical treatment plan, patient summary, and oncologic history) are associated to the new plan. Based on a review of available information, Dr. Tumor’s opinion is that neo-adjuvant chemotherapy should be used with a goal to shrink the tumor prior to surgery. Dr. Tumor elects to add this information to the treatment plan.

Use Cases / Narratives (cont’d) • Manage Chemotherapy Options – Locate Clinical Trials • Dr. Tumor elects to use the information in Eve Everywoman's draft treatment plan to locate clinical trials she may be eligible for. No positive results are returned.

Use Cases / Narratives (cont’d) • Alternate Path – A clinical trial is located • Dr. Tumor elects to use the information in Eve Everywoman's draft treatment plan to locate clinical trials she may be eligible for. Dr. Tumor is notified that Eve is eligible for a breast cancer clinical trial, and she agrees to initial screening. Information on the clinical trial is provided to Eve Everywoman for her to consider consenting to participating. Eve consents, the screening is positive, and Dr. Tumor refers her to the research trial. A referral request form including all pertinent clinical, demographic and financial information is created electronically and sent to the clinical trial system.

Use Cases / Narratives (cont’d) • Manage Chemotherapy Options – Select Chemotherapy Template • Dr. Tumor elects to use the information in Eve Everywoman's draft treatment plan to locate existing chemotherapy treatment templates to find a potentially suitable treatment regimen. • Dr. Tumor is presented a list of possibly compatible regimens. Dr. Tumor believes that a regimen using doxorubicin and paclitaxel will be an effective regimen, and locates the template named, “TT-doxpac.” • Dr. Tumor then integrates a copy of the template and the initial information gathered for the treatment plan. Formulas in the template calculate chemotherapy dosages based on the height and weight of Mrs. Everywoman.

Use Cases / Narratives (cont’d) • Manage Chemotherapy Options – Resolve Chemotherapy Plan Contraindications • Initial alerts associated with use of the template are presented to Dr. Tumor if there are drug-drug or drug-allergy contraindications, long-term toxicity thresholds exceeded, as well as any current lab results or patient observations that might contraindicate using the regimen. Dr. Tumors addresses the alerts.

Use Cases / Narratives (cont’d) • Manage Chemotherapy Options • Dr. Tumor reviews the concomitant medications, labs, monitoring and other activities, chemotherapy doses and administration instructions for any changes that may be desirable based on Mrs. Everywoman’s clinical history, current observations and lab results. Dr. Tumor adds office visits after every 2 cycles, but no other changes.

Use Cases / Narratives (cont’d) • Manage Chemotherapy Options – Resolve Patient Insurance Information • The proposed chemotherapy and concomitant drugs, as well as the labs and other activities are evaluated against Eve Everywoman’s insurance coverage to identify non-formulary and uncovered drugs or services or those requiring prior authorization. Additionally, out-of-pocket costs for Mrs. Everywoman are estimated and attached to the treatment plan. • (Questions: Are costs for the clinic evaluated at this time as well? When is the general availability of particular medications assessed?)

Use Cases / Narratives (cont’d) • Prepare Patient Education Materials • Prefilled patient education materials are retrieved based on Mrs. Everywoman’s cancer staging, overall problem list, the risks and benefits of the regimen selected, the estimated out-of-pocket costs and any demographically-significant issues, such as a different language or someone other than the patient having authority to make medical decisions for the patient. The patient education material is attached to the treatment plan for Eve to help her better understand her specific disease and reasons for the treatment plan proposed.

Use Cases / Narratives (cont’d) • Approve Proposed Medication Plan • Dr. Tumor reviews the entire draft treatment plan and attachments and determines it is ready to present to Mrs. Everywoman. Copies of the proposed treatment plan, including the estimated out-of-pocket patient costs and patient education materials are prepared to share with the patient. Patient consent forms are also generated and attached to the patient’s copy of the plan.

Use Cases / Narratives (cont’d) • Approve Proposed Medication Plan (cont’d) • Dr. Trudy Tumor discusses the proposed treatment plan with Eve Everywoman. Their discussion on chemotherapy includes the following points: treatment intent (curative vs. palliative); chemotherapy drugs and their intended actions against the tumor and potential side effects; estimated patient costs; and any other concerns or issues. Fertility considerations are touched on briefly by Dr. Tumor, but she confirms with Eve that she is not interested in having further children. Mrs. Everywoman consents to the proposed plan and signs the appropriate forms. The approved treatment plan is placed with other active treatment plans, and Eve also receives a copy.

Use Cases / Narratives (cont’d) • Approve Proposed Medication Plan (cont’d) • Dr. Tumor makes a modifiable treatment roadmap to track when chemotherapy is due and given, including dates, chemotherapy dose, recommended studies to evaluate disease response and test for drug toxicities (such as Echocardiograms, etc). Mrs. Everywoman is given a treatment calendar that includes a schedule for all her medications and lab work to be done throughout the course of her chemotherapy. She reviews the calendar and agrees to the schedule as outlined. • Question: Original narrative suggests this happens well after the patient agrees to the treatment plan. If scheduling becomes relatively automated, would there be a good reason they could not get a preliminary treatment calendar to take home so they compare it with their personal calendar?

Use Cases / Narratives (cont’d) • Notify Other Providers about Chemotherapy Plan • A notification is sent to Dr. Cutter informing him of the treatment plan and confirming initiation of treatment.

Use Cases / Narratives (cont’d) • Create Chemotherapy Plan – Alternate Scenarios • Patient does not consent • Dr. Trudy Tumor discusses the proposed treatment plan with Eve Everywoman. Their discussion on chemotherapy includes the following points: treatment intent (curative vs. palliative); chemotherapy drugs and their intended actions against the tumor and potential side effects; estimated patient costs; and any other concerns or issues. Fertility considerations are touched on briefly by Dr. Tumor, and Eve indicates she is very concerned about her ability to have children. Mrs. Everywoman does not consent to the proposed plan.

Use Cases / Narratives (cont’d) • Patient does not consent (cont’d) • Mrs. Everywoman signs an acknowledgement that the proposed treatment plan was discussed and declined. Dr. Tumor notifies Eve that she can reconsider her decision or seek a second opinion. The treatment plan and signed acknowledgement are stored for record keeping purposes or in case Mrs. Everywoman changes her decision.

Use Cases / Narratives (cont’d) • Other questions • Once the treatment plan is in place, are the resulting progress notes, medication administration records, and lab results considered part of that plan, or are they separate items that have an associated to the treatment plan? What about referrals made to other providers made during the performance of the plan?

Domain Expert Working Session