Checking Eligibility: Keys To Successful Patient Enrollment

Transcription

1 Checking Eigibiity: Keys To Successfu Patient Enroment Katie Dixon Cinica Research Professionas Committee Member New Cinica Research Professiona Orientation, November 2, 2016

2 Objectives Checking Eigibiity: Keys To Successfu New Patient Enroment Identify key steps to foow. Know where to go for required resources. Recognize which documents provide sufficient information to confirm eigibiity. Identify how to avoid common pitfas.

3 Begin at the Beginning: Standardize the Process An Exampe: Many Sma Steps Standardization decreases errors and increases efficiency

4 Resources: Know Where to Go Use current version of the protoco ALWAYS go to ALLIANCE or CTSU (printing/fiing eads to errors) Eigibiity section 3 Strat Factors section 4 Registration section 4 Pre-registration assessments section 5 Open Enroment Form ocated on ALLIANCE under the protoco page, Case Report Forms & CTSU under Protocos, type your protoco, LPO documents, Patient Enroment Documents

5 What to Print When Working Up a Patient Using the current version of the protoco found on ALLIANCE or CTSU Print Eigibiity from body of protoco and (highy suggested) print stratification factors, as these must be documented Document/Note sources for each eigibiity requirement Print Test schedue and foot notes. Document the date each item is competed Print the Open Enroment Form Highy recommended to use an interna Randomization Checkist

6 Documentation & Sources Confirm Eigibiity Criteria, Test Schedue & Stratification Factors found in the protoco For each criteria, document sources Ideay an auditor coud view just the sources you document and concude the patient is eigibe. Many eigibiity points require mutipe sources, ex: path & abs. Read the entire eigibiity point a the way through Avoid a Pitfa: Providing this documentation aows for easy confirmation at audits and for seamess understanding in case of staff turnover

7 Exampe of Source Documentation 3.2 Patients must have histoogicay or cytoogicay proven primary non-sma ce ung cancer (adenocarcinoma, arge ce carcinoma, squamous or unspecified). Disease must be Stage IV, as defined in appendix II. Disease may be either newy diagnosed or recurrent after previous surgery and/or irradiation. Patients with additiona esions in an ipsiatera non-primary obe without M1a or M1b disease wi not be considered to have Stage IV disease and are not eigibe. 3.2 Patients must have histoogicay or cytoogicay proven primary non-sma ce ung cancer (adenocarcinoma, arge ce carcinoma, squamous or unspecified). Source = pathoogy/cytoogy report Disease must be Stage IV, as defined in Appendix II. Review appendix II, source ikey = CT CAP or bone scan, or path from biopsy of a metastatic ocation Disease may be either newy diagnosed or recurrent after previous surgery and/or irradiation. Source = MD note with the history of the present iness and if recurrent dz then aso MD note from initia diagnosis noting the treatment given. Patients with additiona esions in an ipsiatera non-primary obe without M1a or M1b disease wi not be considered to have Stage IV disease and are not eigibe. This ikey doesn t require additiona sources since you noted the sources for compete staging above.

8 An Exampe for you! Work in groups to note the sources you woud ikey use to meet each eigibiity point.

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10 Where Things Get Tricky The source document MD noting T2N1M0 is good BUT What is the source for staging? The information used to draw that concusion is aso needed. Ex: path, EUS, bone scan, etc.. Medica History doesn t match Medication List Exampe: Patient taking synthroid but no history of thyroid abnormaity Tip: Review PMH and Meds with indication at time of consent

11 Detaied Steps Is the protoco currenty OPEN at your institution Studies temporariy cose, updates can require IRB review Are there any specia requirements for training or credentiaing Check when opening a protoco Gather Protoco Documents: Go to ALLIANCE website Directy to ensure most current version

12 Detaied Steps Continued Protoco Documents Print OPEN Enroment Form Print Eigibiity Print Test Schedue w/footnotes Print Stratification Factors Review Registration Procedures/Instructions Are there any required sub studies, QOL s, pre-reg steps, how ong to initiate treatment, etc. Check how quicky treatment must be initiated this impacts timing for registration Review Drug Section, shoud you order any drug in advance, how ong does it take for deivery Print the consent when you are ready to meet with the patient in case there are amendments that come out

13 Standardize the Process! Deveop a process and stick with it for each new patient. Exampes of standards used at our institution Pre-Study Checkist (see next page for our exampe), we highight a required tests, write required times on the eft (ex:<14d) & write dates as they are competed Review items that can not change EARLY in your process. You can not change medica history or the stage of a patient. REVIEW and CONFIRM these eary. Use the staging manua to confirm stage. Randomization Checkist (you have a copy). Used to track when tasks are competed and to note any questions we have. This too heps in busy environments & in case of absence or at time of audit you can quicky refer to any questions that were expored. We use bright paper for this.

14 Oncoogy Research Pre-study Checkist Date: Patient Name: Race: Medica Record #: Required Laboratory Tests q CBCD_09/01/ d=09/15/16 q CMP q LDH q Magnesium q Uric Acid q UPC Ratio q Urinaysis q PT/INR/PTT q Fibrinogen q Pregnancy q Tumor Marker q Fow Cytometry q Immunophenotyping q Trigycerides/Choestero q Other q Other q Other Protoco Number: Aergies D.O.B.: / / MD: Diagnosis: Medications/Indication Other Notes Vita Signs: PS: Ht: in cm Wt: b kg BSA: m 2 BP: / P/R: / Temp: Date Sign: Required Physician Visits q MD Onc_09/02/16+14d = 09/16/16_ q Gynecoogist q Rad Onc q Surgeon q Other Required Scans/Exams q MRI/CT Brain q MRI/CT Neck q MRI/CT Chest q MRI/CT Abdomen q MRI/CT Pevis q Chest X-Ray q Bonescan q Mammogram q MUGA/Echo q EKG q Coonoscopy/BE q Endoscopy q Other q Other Required Study Items q Pathoogy submission q Study Kit before Reg/Rando q Study Kit after Reg/Rando q Quaity of Life q Chemo Schedued q Provided Drug q Pharmacy Contacted q Other

15 Stage Your Patient On your own, stage your patient. Use the stage derived by others as a confirmation. Review a imaging for questionabe areas that need foow-up. These must be addressed either by comments from the MD or by additiona imaging. Be sure a areas of disease are evauated *sounds basic but things get missed*. If there was ony one sma area of disease and it was biopsied, imaging post biopsy may be necessary to evauate the post biopsy size for baseine tumor measurements.

16 Stage Your Patient Continued What is needed to stage varies based on primary ocation of the tumor. Some exampes: Breast Patients, use the pre-op physica to note infammatory or not, mobie or fixed nodes, etc.. Breast Patients, read carefuy through the sentine node procedure was it successfuy performed, did they find hot/bue nodes? Lung, what eves of nodes were samped? Did the operative note mention areas examined but where no nodes were present? Coon/recta, distance above the ana verge on coonoscopy, obstruction, en boc resection, adhesions, were there mutipe areas of invovement and if so did the pathoogist consider these separate primaries? Do a path reports show the same histoogy? Do you have the most recent FISH/IHC/Hormone testing resuts be sure to view origina reports.

17 Wrapping Up Review things that can not change eary in the process Standardize your process Don t store documents. Discuss any abnormaities with the MD and document what the concusion is. Document sources for each eigibiity point as you are going through the work-up. Review strat factors with the MD and document these. Good practice, have the MD sign and date eigibiity from the protoco, registration worksheet and strat factors.

18 Recent Discoveries: 1. Incompete Staging (more tests needed to be ordered to determine T stage in EG pt, and N stage in breast pt 2. Missing Test Schedue Items 3.Surgica procedure incompete (ex: ung nodes not sufficienty samped or documented, Sentine Node procedure faied so random nodes samped (SN biopsy required), mutipe areas on coonoscopy identified but ony one resected, en boc resection not performed but required for protoco) 4. Pt found to have underying disease based on required tests from protoco (diabetes, bradycardia) 5. Pre-study physica excuded breast but pt had breast cancer 6. Underying condition in confict with treatment (anke needing surgery but tx woud had to have been deayed onger than the protoco aowed in the time to initiate treatment) 7. Sef reported history conficted w/underying conditions which outside medica record documented or for which they are currenty taking medication (ex: taking HTN meds but report no history of HTN and protoco excudes HTN) 8. Pts understanding of potentia time to initiate treatment. Pt decined study when additiona tests needed to be ordered 9. Pt had active infection which they were receiving treatment for by primary care MD so they didn t mention to Med Onc however meds showed underying probem & excuded from entry at that time.

19 QUESTIONS?????