INSTRUCTIONS FOR STUDY CONCOMITANT MEDICATION DISPENSING, DOSING AND ADHERENCE FORM CMF, VERSION A (QxQ)

Transcription

1 INSTRUCTIONS FOR STUDY CONCOMITANT MEDICATION DISPENSING, DOSING AND ADHERENCE FORM CMF, VERSION A (QxQ) I. GENERAL INSTRUCTIONS The Study Concomitant Medication Dispensing, Dosing and Adherence Form is filled out by the study coordinator at every visit starting with the baseline visit (visit 2). However, if no study concomitant medication was dispensed at the previous contact/visit or is dispensed at the current visit, then only items 1 and 2 are completed and the remainder of the form skips to the comments section. The study concomitant medications are: Metformin (850mg) Benztropine (1mg) Simvastatin (20mg) The purpose of this form is to collect information on 1. any study concomitant medication dispensed at the current visit 2. any study concomitant medication returned at the current visit 3. any study concomitant medication dispensed at the last visit/contact 4. adherence based upon 2 and 3 above 5. any study concomitant medication dosing amounts Patients will be paid an additional $5 at each study visit, if they return their blister pack(s) from the previous visit. Please note patients should be encouraged and reminded to bring their blister pack(s) starting at Visit 3. The study coordinator should be familiar with and understand the document titled "General Instructions For Completing Paper Forms prior to completing this form. Special instructions that apply to all three study concomitant medications: When recording the number of pills dispensed from the last visit/sequence (in items 4a, 7a and 10a), it is very important that only the pills dispensed at the last patient contact are recorded here. If a patient comes in for an unscheduled visit to receive additional study concomitant medications, then a SEQ 002 CMF is completed for that unscheduled visit and pill return and dispensing is completed for the time between the scheduled visit and the unscheduled visit. When recording the number of pills returned today (in items 4b, 7b and 10b), it is again important to record the pill count from only the blister pack(s) dispensed at the last patient contact. If a patient brings in more blister packs than expected, count only the pills from the last dispensation. For example, if the patient forgot to bring the visit 5 blister packs to visit 6, and then brings both visit 5 and visit 6 packs to visit 7 at visit 7 count only the pills remaining in the visit 6 blister pack. At visit 6, the pill count section would have been skipped since no blister packs were returned. Header Information: The header information consists of key fields which uniquely identify each recorded instance of a form. PATIENT ID NUMBER: Affix the pre-printed label to the form. This is a unique 8-character code assigned at the DCC for each study patient. Labels are provided. COATS Study Concomitant Medication Dispensing and Adherence Form Version A (CMFA) QxQ, 10/21/08 Page 1 of 5

2 FORM CODE: This is a three-letter mnemonic code for the form, which is pre-assigned as CMF. VERSION: This is a one-letter version assigned to the form, which is pre-assigned as A. VISIT: Fill in the visit number. Possible visit numbers are as follows: 02, 03, 04, 05, 06, 07, 08, 09, 10, or 11. SEQ #: Sequence number is used to indicate whether this is the initial medication dispensing or a second dispensing for a given visit. In most cases, medication is dispensed only once per visit number, in which case, the sequence number is 001. However, if medication is dispensed between visits, for whatever reason, the sequence number will be 002 (and 003 if it is dispensed a third time for the same visit number). PATIENT INITIALS: Enter the first, middle, and last initial of the patient. For those with no middle name, use a (dash). For example: A Z VISIT DATE: Enter the date on which the data was collected. Code in numbers using leading zeroes where necessary to fill all boxes. For example, September 6, 2008, would be entered as: 0 9 / 0 6 / M M D D Y Y Y Y II. DETAILED INSTRUCTIONS FOR EACH ITEM A. TYPE OF PARTICIPANT CONTACT Item 1. Item 2. Record S (scheduled) if this is a protocol scheduled clinic visit. Record U (unscheduled) if this is an unscheduled visit or contact. Record Y (yes) if any concomitant medications have been prescribed/dispensed for the patient, either today or at the last medication Record N (no) if no concomitant medications were prescribed/dispensed and skip to Item 12. If the answer is Y (yes) to item 2, then at least two questions for each study concomitant medication must be answered to complete the form. This determines which study concomitant medication was dispensed. METFORMIN 850MG RETURN / ADHERENCE Item 3. Check Y (yes) or N (no) if metformin was dispensed at the last visit/medication If yes, go to Item 4, if no, skip to Item 5. Item 4. Check Y (yes) if any blister packs are returned today and go to Item 4a. Check N (no) if none are returned and skip to Item 4f.. Item 4a. Record the number of pills dispensed from the last visit/sequence CMFA5c. Item 4b. Record the number of pills returned today that were dispensed at the last medication Item 4c. Subtract Item 4b from Item 4a (Item 4a minus Item 4b) to calculate the number of pills taken. COATS Study Concomitant Medication Dispensing and Adherence Form Version A (CMFA) QxQ, 10/21/08 Page 2 of 5

3 Item 4d. Calculate the number of pills the patient should have taken by multiplying the number of days since the last study visit/contact by the CMFA5b (number of pills to achieve daily dose) from Item 4e. Calculate the percentage of pills taken by dividing Item 4c (number of pills taken) by Item 4d (number of pills patient should have taken) and multiplying by 100. There is no formula for determining adherence. It involves considering all available information and making the best judgment accordingly. If a discrepancy exists between what the patient was suppose to take and what he did take, remember to seek the patient s input as to why there might be a discrepancy. Item 4f. Item 4f should be completed at Visits Ask the patient and record how many days they did not take medication since they last received medication. Item 4g. Item 4g should be completed at Visits Ask the patient and record how many days they Item 4h. Record the letter that corresponds with your best assessment of the patient s adherence. A = always/almost always B = usually/most of the time, C = about half the time, D = sometimes, E = never/almost never. Item 4i. If the answer to Item 4h is E (never/almost never), please indicate whether or not the patient took ANY study medication since If the answer to Item 12 is A, B, C or D then skip to Item 5. METFORMIN 850MG - DISPENSING Item 5. Record Y yes if metformin is being dispensed today and go to Item 5a. Record N no, if metformin is not being dispensed today and skip to Item 6. Item 5a. Record the daily dose prescribed today, that is the expected dose for MOST days between Item 5b. Record the number of pills to achieve the daily dose. Item 5c. Calculate the number of pills patient will need dispensed today to achieve daily dose between BENZTROPINE 1MG RETURN / ADHERENCE Item 6. Check Y (yes) or N (no) if benztropine was dispensed at the last visit/medication If yes, go to Item 7, if no, skip to Item 8. Item 7. Check Y (yes) if any blister packs are returned today and go to Item 7a. Check N (no) if none are returned and skip to Item 7f. Item 7a. Record the number of pills dispensed from the last visit/sequence CMFA8c. Item 7b. Record the number of pills returned today that were dispensed at the last medication Item 7c. Subtract Item 7b from Item 7a (Item 7a minus Item 7b) to calculate the number of pills taken. Item 7d. Calculate the number of pills the patient should have taken by multiplying the number of days since the last study visit/contact by the CMFA8b (number of pills to achieve daily dose) from COATS Study Concomitant Medication Dispensing and Adherence Form Version A (CMFA) QxQ, 10/21/08 Page 3 of 5

4 Item 7e. Calculate the percentage of pills taken by dividing Item 7c (number of pills taken) by Item 7d (number of pills patient should have taken) and multiplying by 100. There is no formula for determining adherence. It involves considering all available information and making the best judgment accordingly. If a discrepancy exists between what the patient was suppose to take and what he did take, remember to seek the patient s input as to why there might be a discrepancy. Item 7f. Item 7f should be completed at Visits Ask the patient and record how many days they did not take medication since they last received medication. Item 7g. Item 7g should be completed at Visits Ask the patient and record how many days they Item 7h. Record the letter that corresponds with your best assessment of the patient s adherence. A = always/almost always B = usually/most of the time, C = about half the time, D = sometimes, E = never/almost never. Item 7i. If the answer to Item 7h is E (never/almost never), please indicate whether or not the patient took ANY study medication since If the answer to Item 12 is A, B, C or D then skip to Item 8. BENZTROPINE 1MG - DISPENSING Item 8. Record Y yes if benztropine is being dispensed today and go to Item 8a. Record N no, if benztropine is not being dispensed today and skip to Item 9. Item 8a. Record the daily dose prescribed today, that is the expected dose for MOST days between Item 8b. Record the number of pills to achieve the daily dose. Item 8c. Calculate the number of pills patient will need dispensed today to achieve daily dose between SIMVASTATIN 20MG RETURN / ADHERENCE Item 9. Check Y (yes) or N (no) if simvastatin was dispensed at the last visit/medication If yes, go to Item 10. If no, skip to Item 11. Item 10. Check Y (yes) if any blister packs are returned today and go to Item 10a. Check N (no) if none are returned and skip to Item 10f. Item 10a. Record the number of pills dispensed from the last visit/sequence CMFA11c. Item 10b. Record the number of pills returned today that were dispensed at the last medication Item 10c. Subtract Item 10b from Item 10a (Item 10a minus Item 10b) to calculate the number of pills taken. Item 10d. Calculate the number of pills the patient should have taken by multiplying the number of days since the last study visit/contact by the CMFA11b (number of pills to achieve daily dose) from Item 10e. Calculate the percentage of pills taken by dividing Item 10c (number of pills taken) by Item 10d (number of pills patient should have taken) and multiplying by 100. There is no formula for determining adherence. It involves considering all available information and making the best judgment accordingly. If a discrepancy exists between what COATS Study Concomitant Medication Dispensing and Adherence Form Version A (CMFA) QxQ, 10/21/08 Page 4 of 5

5 the patient was suppose to take and what he did take, remember to seek the patient s input as to why there might be a discrepancy. Item 10f. Item 10f should be completed at Visits Ask the patient and record how many days they did not take medication since they last received medication. Item 10g. Item 10g should be completed at Visits Ask the patient and record how many days they Item 10h. Record the letter that corresponds with your best assessment of the patient s adherence. A = always/almost always B = usually/most of the time, C = about half the time, D = sometimes, E = never/almost never. Item 10i. If the answer to Item 10h is E (never/almost never), please indicate whether or not the patient took ANY study medication since If the answer to Item 12 is A, B, C or D then skip to Item 11. SIMVASTATIN 20MG - DISPENSING Item 11. Record Y yes if simvastatin is being dispensed today and go to Item 11a. Record N no, if simvastatin is not being dispensed today and skip to Item 12. Item 11a. Record the daily dose prescribed today, that is the expected dose for MOST days between Item 11b. Record the number of pills to achieve the daily dose. Item 11c. Calculate the number of pills patient will need dispensed today to achieve daily dose between E. Administrative information Item 12. Item 13. Comments. If any (this comment field is optional), record brief, pertinent comments related to the overall collection of the data on this form. There are 3 lines, 70 characters per line, to record these comments in the DMS. Staff Code Number. The person at the clinic who collected the data on this form enters his/her code number in the boxes provided. This code is on every form. The DCC assigns a code to each study member based upon his/her certification for specific areas of data collection within the COATS study. Please ask the study coordinator if you are unsure of your code. COATS Study Concomitant Medication Dispensing and Adherence Form Version A (CMFA) QxQ, 10/21/08 Page 5 of 5