Study Design and Materials

Transcription

1 Study Coordinator Training November 13, 2008 Agenda Study Design and Materials Screening and Randomization Study Medication Height and Waist Measurements Data Collection Procedures Site Monitoring Data Management/Website 1 2 Study Design and Materials Kimberly Ring, MPH UNC Biostatistics Data Coordinating Center Study Design Visit schedule Visit 1 (Screening) Visit 2 (Baseline) Visit 3 (week 1) Visit 4 (week 2) Visit 5 (week 4) Visit 6 (week 8) to Visit 11 (week 28) Un-blinded (except for blinded raters) 3 4 Study Materials Study Manual Patient Binders Blinded Rater Binders Screen Fail Binder Behavioral Treatment Manual Behavioral Treatment Handbooks Patient ID labels Study Reference Manual Study Reference Manual with Appendices App 1 Instrument Instructions App 2 Lab Manual App 3 Data Completion Guide App 4 Forms and QxQs App 5 Data Management Manual App 6 Quick Reference Guides 5 6 1

2 Study Materials Measurement Instruments Scales Pedometers Stadiometer (from CAMP) Gulicks (from CAMP) Study medications and supplies Bottles of the 6 study meds in 100 pill counts Blister packs Pill counting trays Screening and Randomization Kimberly Ring, MPH 7 8 Screening One unique ID per patient Use same ID in rescreening BSSNNNNQ ID structure DEM, VSS, SCD, MHX, BSF UBACC and consent Labs IEC (8 inclusion, 10 exclusion) Inclusion Exclusion (IEC) form 9 10 Inclusion Exclusion cont d Checking Eligibility Status

3 Randomization Randomization Form Verify eligibility Ineligibility status may be reversed under limited circumstances with consultation with and approval of PMO Labs marginally out of range Concomitant cimetidine or ranitidine in low dosages Eligibility Changing Eligibility Status Changing Eligibility Status Changing Eligibility Status

4 Randomization DMS randomizes eligible participants to either Olanzapine + Metformin Perphenazine + Benztropine Aripiprazole Study physician determines appropriate dose of antipsychotic and concomitant medication Telephone back-up procedures in place for randomization Study Medication Erika Libero, BA UNC-Psychiatry Schizophrenia Trials Network Drug Dispensing Each site supplied with medication bottles and blister packs Study antipsychotic medication dispensing, dosing and adherence is tracked on the AMF form Study concomitant medication dispensing, dosing and adherence is tracked on the CMF form Drug Supply Each site sent enough of each medication to get started Re-supply need is tracked with the Drug Inventory Log Re-supply orders go to the Clinical Project Coordinator Please allow 4 days for shipment Drug Inventory Log Blister Packs - Overview Aripiprazole 10mg # Pills Dispensed to Pt Reason for Entry # Bottles # Pills on Hand Total # of DATE OR (Refer to Key) on Hand (100 per Bottle) Pills Left Returned to Aptuit MM/DD/YYYY 9/11/2008 IO / 300 9/13/2008 PV /15/2008 PV /16/2008 PV /30/2008 EX /2/2008 RS / /30/2008 DR How to build the Blister Pack How to fill the Blister Pack By Week where one pack = one week By Day where one cell = one day, and one pack = 28 days For titration (visit 2/Baseline and Visit 3) General Tips

5 Building the Blister Pack Three pieces 3 panel blister pack frame, sheet of plastic blister pack cells, foam stabilizer (reusable) Open the blister pack frame so it looks like the picture below Building the Blister Pack Peel away adhesive paper to expose only the far right panel (leaving the middle panel covered) and set the sheet of plastic blister pack cells into the holes of the right panel. Set right panel into foam stabilizer for easy filling. Fill Blister Pack with medication. Peel off the adhesive paper completely. Bring the middle panel to meet the right panel and seal blister pack Building the Blister Pack Fold the far left panel over blister pack cells like a book cover. Label the cover of the blister pack and remove the foam stabilizer. Blister Pack Labeling Label cover with patient name, visit number, COATS contact Sticker, and blister pack number. e.g. ¼ means this is blister pack 1 out of 4 total Filling the Blister Pack by week The blister pack is designed to be used weekly. It is labeled from top to bottom with the day of the week starting with Sunday. For each day, there are 4 cells that correspond to 4 different dosing times: Morning, Noon, Evening, and Bedtime 29 Filling the Blister Pack by week Depending on how you are looking at the blister pack, dosing times go from left to right or right to left. Front: Medication Visible L to R: Morning Bedtime BE CAREFUL! Back: tear-able side / what you will see when filling the pack L to R: Bedtime Morning 30 5

6 Filling the Blister Pack by week Things to consider: What medication(s) the patient is on When dosing will occur Grouping medication where possible Plan out how you will fill the blister pack using the blister pack plan Dosing will begin the next day unless the patient takes medication at bedtime Blister Pack Plan Note: Morning to Bedtime goes from Right to Left. This is what you will see when filling the blister pack Filling the Blister Pack by week Blister Pack Plan Example Mark X s over unused cells with black marker Mark dates along the right side (mm/dd) Filling the Blister Pack by day For patients who take medication once a day, fill the blister pack so one cell = one day and one blister pack = 28 days. Take a black marker and mark out all weekday and time of day labels on the blister pack (front and back) Fill blister pack with the same dose in each cell Filling the Blister Pack by day On the back, tear-able side of the blister pack, write in dates on each cell being sure not to puncture the paper

7 Blister Packs - Titration If a patient comes into COATS on an antipsychotic, they must be cross titrated onto their new medication in 2 weeks. Blister packs will be filled with both the existing and new antipsychotic. Remind the patient to bring in their existing antipsychotic medication for visit 2 (baseline) and visit 3. Cross titration must be completed by visit 4 Blister packs - Titration Titrating doses will be determined by the study physician. Sit down with your study physician and fill out the blister pack plan at titrating visits (visits 2 and 3) General Notes on Blister Packs Give the patient enough medication to last them until their next visit plus a few days for scheduling purposes. Never redispense meds. Keep returned medication in another bottle until the end of the study. Keep filled out Blister pack plans in the patient binder for your own reference. Blister Packs and the Patient Make sure the patient understands the blister pack as the blister pack may be filled differently from visit to visit. Remind the patient that they receive an extra $5 for bringing in ALL dispensed blister packs Procedures to Measure Height and Waist Ingrid Rojas, MPM UNC-Psychiatry Schizophrenia Trials Network 41 Why is height measurement important? Body mass index is an important outcome measure Why do it twice? In previous studies when we measured height at different time points, several subjects grew or shrank 1-6 inches. An average of two measurements is more accurate than a single measurement What if the two measurements are off by a relatively large amount? 42 7

8 How to Measure Height Have the person remove his/her shoes. Remove hat or other head gear. Have the subject stand with his/her back to stadiometer, assuming a normal, upright posture. Lower headpiece until it rests on top of head Read off height in inches Have person get off stadiometer Repeat measurement Wrong Facing wrong way. Shoes were left on Wrong Facing wrong way

9 Wrong Hair piled up on head Wrong Not standing up straight Wrong Shoes on

10 Right Right How to Measure Waist Waist measurement can be over light weight clothes Have the subject remove any coats or sweaters. How to Measure Waist Have the subject find the top (superior) of the iliac crest Which picture shows the subject finding the superior portion of the iliac crest? Put the tape around the subjects waist, then have the subject find the top of the ilicac crest. The top of the subject s thumbs should be line with the top of the iliac crest

11 Pull the tape measure taunt to the point between the two red balls. The correct measurement is where the 0 lines up. Use inches Data collection procedures Kimberly Ring, MPH Labs Labs drawn at visits 1, 5, 7, 11 No 2-hour OGTT Request lipid panel and liver function tests (LFTs) if simvastatin was introduced at previous visit OR if dose was adjusted at previous visit BSF modified

12 New/Modified Forms OMR record antipsychotic (if any) at baseline LLA do not record simvastatin on this form AUQ Alcohol Use Questionnaire AMF Antipsychotic Medication Dispensing, Dosing and Adherence from blister packs CMF Study Concomitant Medication Dispensing, Dosing and Adherence from blister packs SAE Serious Adverse Events slightly simplified; additional form to fax to PMO Behavioral Treatment Intervention All patients receive Same as CAMP Nine sessions lasting approximately 20 minutes each After Visit 5, interim phone calls made to participants to reinforce the program and answer questions Serious Adverse Event Reporting SAE form entered in DMS immediately upon awareness of the event First record is entered with SEQ 101 and the visit number of the last scheduled visit prior to the event Updates or changes entered in next sequential SEQ Additional form is completed and faxed to PMO Site Monitoring Kimberly Ring, MPH Goals of the visit Goals of the Visits Visits scheduled after first or second randomization Verification of 100% of data provided for Screening and Randomization visits Review of patient files, medical records and other source documents Tour of facilities, review of site operations and staffing Review of on-site regulatory documentation requirements and compliance

13 Goals of the Visits Goals of the Visits Review of study protocol and procedures Includes drug storage and distribution Specimen collection and processing Packaging and shipping techniques Equipment and maintenance, supplies and storage Maintaining the blind Serious Adverse Events Use of Data Management System Recruitment Issues Full Participant Visit Observation If possible and with patient permission Summary of Visit with Principal Investigator, Study Coordinator Questions and answers, input from site Data Management Data Management Kimberly Ring, MPH Same Data Management System (DMS) as in CAMP Reports Queries Sites with DMS experience from CAMP are certified Data Management Data entered within 2 business days of data collection Review reports that indicate introduction of simvastatin or benztropine IEC and RDM no auto-populating of eligibility criteria Call HelpDesk with DMS or randomization questions Web address COATS website Secure website with appropriate access to CAMP, COATS and METS Study coordinators have username/password access DMS is on a different server/different location for security reasons

14 COATS website STN website Website contains: General news items Directory of COATS Investigators and staff facility using the directory Documents storage Protocol MOP Study forms and QxQs Call agendas/minutes STN splash page COATS homepage COATS website COATS website

15 HELP? Study Reference Manual (contact information and other useful information) Protocol questions contact Study Manager or Study Coordinator at UNC Psychiatry Data Management System/Randomization questions contact DCC at