Reducing Adverse Drug Events With Anti Coagulation Clinics. McFarland Clinic. McFarland Protime Clinic 09/05/12
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1 Reducing Adverse Drug Events With Anti Coagulation Clinics Dr. Donald Skinner, MD McFarland Clinic 182 Physicians (149 Shareholders) 40 Mid Level Providers 13 Administrators/Executive Directors 1,200 Support Staff 10 Towns 22 Outreach Sites McFarland Protime Clinic Three Sites Ames Carroll Marshalltown Approximately 1,100 Patients 1
2 Our Goals Decrease Thrombotic Events Avoid Adverse Drug Events Protime Clinic Staffed by RNs Included in the Appendix Developed by our MIS Team Protocol Driven Emb Can be seen by providers anywhere with access to Epic Protime Clinic Nurses provide patient education Herbal med interactions Most follow up by phone Drug interactions Food lists Nurse visits for some 2
3 Charges QW G0250 Nurse Visit Protime Visit Cap Draw (Non Medicare) Home Testing (Every 4tjh INR) National Results Bleeding Events Inpatient Decreased by 45 98% Outpatient Decreased by 53 95% Thrombotic Events Journal of Quality and Patient Safety Potential Cost Savings $1,630 Per Patient Per Year Everett Clinic
4 Keys to Success Protocol Driven Key Contact Person RN Pharmacist NP/PA Enroll All Patients Close Follow Up Embed EMR if Able Appendix Protime Clinic Dr. Donald Skinner, MD A ATE/VTE Risk Assessment High Intermediate Low Bleeding Bleeding B Risk Assessment B Risk Assessment B Bleeding Risk Assessment High Low High Low High Low Discontinue Continue Discontinue Continue Discontinue Continue C C C LMWH LMWH Procedure Therapeutic Therapeutic Prophylactic Restart Warfarin Procedure Procedure Restart Warfarin D Restart Warfarin D LMWH LMWH Therapeutic Therapeutic Prophylactic Courtesy of Western Montana Medical Clinic 4
5 Table 3: CHADS 2 Scoring Criteria Table 5: Suggested Thromboembolic Risk Stratification When Discontinuing VKAs (Adapted from Guyatt CH et al. Chest 2008; 133 (Suppl 6): 305S) Criteria Point Value Condition High Risk Moderate Risk Low Risk Congestive Heart Failure +1 Hypertension +1 Age > Atrial Fibrillation Recent (<3 mos.) stroke or TIA CHADS score 5 6 Rheumatic heart disease CHADS score 3 4 CHADS score 0 2 Diabetes mellitus +1 Stroke history or TIA +2 Table 4: Risk of Stroke CHADS 2 Stroke Score Risk (95% CI) (1.2 3) Mechanical Heart Valve Any caged ball or tilting disc valve in mitral/aortic position Any mitral valve prosthesis Recent (<6 mos.) stroke/tia Bileaflet AVR with major risk factors Bileaflet AVR without major risk factors (2 3.8) ( ) ( ) ( ) ( ) ( ) 1. Fuster V et al. J Am Coll Cardiol 2006; 48: Gage B et al. JAMA 2001; Arch Intern Med. 2003;163(8): Venous Thromboembolism (VTE) VTE within past 3 VTE within 3 12 months months Severe thrombophilia Non severe (def. in protein C, S, or thrombophilia antithrombin) Active cancer antiphospholipid Recurrent VTE antibodies), or Multiple thrombophilias Courtesy of Western Montana Medical Clinic VTE more that 12 months ago Table 9: Bridging Guidelines For Specific Patient Populations 5 Patient population Patient population subgroup Bridging recommendation Patients with mechanical heart valve, atrial fibrillation, or prior VTE High risk for thromboembolism Moderate risk for thromboembolism Low risk for thromboembolism Bridge anticoagulation with therapeutic dose LMWH or UFH over no bridging (1C). Therapeutic dose LMWH is preferred over UFH (2C). Bridge with therapeutic dose LMWH, therapeutic dose UFH or low dose LMWH over no bridging (2C). Therapeutic dose LMWH is preferred over other options (2C). Bridge with low dose (prophylactic) LMWH or no bridging over therapeutic dose LMWH or UFH (2C). Patients undergoing minor dental procedures Patients undergoing minor dermatologic procedures Patients undergoing cataract removal Do not interrupt (1B) or aspirin therapy (1C). Can Administer an oral pro hemostatic agent (1B). If patient is receiving clopidogrel, refer to guidelines listed in above table. Do not interrupt or aspirin therapy (1C). If patient is receiving clopidogrel, refer to guidelines listed in above table. Do not interrupt or aspirin therapy (1C). If patient is receiving clopidogrel, refer to guidelines listed in above table. Courtesy of Western Montana Medical Clinic Days Relative to Anticoagulation Management Surgery 10 to 7 Assess thrombosis and bleeding risk Determine appropriate bridging plan 7 Stop aspirin or other antiplatelet therapy 5 Stop Warfarin; INR testing 4 or 3 Start LMWH 1 2 days after Warfarin discontinued (24 48 hours) 2 LMWH 1 Last dose of LMWH, ½ normal daily dose; INR and CBC count testing. 0 = Surgery Resume hours post procedure + 1 Resume LMWH (possibly low dose) & +2 or +3 LMWH + Warfarin +3 6 Stop LMWH once INR is therapeutic Courtesy of Western Montana Medical Clinic 5
6 2011 Anticoagulation Clinic Outcomes Review Anticoagulants are used to prevent and treat blood clots. We manage >2,000 patients with a team approach to care. Our approach is comprehensive and progressive in ensuring we minimize the complications and maximize the outcomes for our patients. Cost Avoidance for Our Patients: $3.5 Million $1,630 per patient/year based on 1998 benchmark study different benchmark 30% 25% 20% Usual medical care (no ACC clinic process) External ACC (benchmark) TEC ACC % 11.80% 10% TEC ACC % 0% 3.90% 2.51% 3.30% 1.95% 1.60% 0.88% 0.44% 0.60% 0.88% Major bleeding Thromboembolism TEC ACC 2011 Courtesy of Evertt Clinic McFarland Clinic PC Administrative Protime Clinic Protocol The McFarland Clinic Protime Clinics are staffed with cardiology nurses (Ames) and Registered Nurses (Marshalltown) who operate under current standing orders written approved by McFarland Clinic physicians. Patient Care Options: Coumadin is a dangerous medication with potentially fatal complications. It is statistically proven that patients receiving face to face management suffer fewer complications and hospitalizations. Therefore, it is our recommendation that all Coumadin patients receive face to face management. The patient may visit the Protime Clinic Nurse with lab testing completed by finger stick. Results are immediately available with medication adjustments and education completed during the encounter. An appointment is required. The patient may alternatively visit a previously designated lab with results obtained by venous collection or finger stick (method determined by lab). The patient will be notified of medication adjustments via telephone within hours. An appointment may be required by the lab. Patients must have a phone or contact information, and should be encouraged to contact the Protime Clinic if they have not received results within 48 hours. Standard of Care Patients will be referred to the Protime Clinic by Physicians/PA s/np s. Any order received that is not personally signed by the ordering physician will not be accepted. Orders will be renewed/updated yearly. Protime nurses will adjust Coumadin dosages according to INR levels. Protime nurses do not order, adjust or discontinue Lovenox, Heparin, or Vitamin K without physician consultation/orders. Patients new to Coumadin will have their first visit within 3 5 days of starting Coumadin. When having two consecutive INRs in the target range, frequency of recheck appointments is based on the interval schedule defined below; however, in most instances interval Protime levels are checked at least monthly. Some extremely stable patients may go longer (only if ordered by their physician). The ordering physician is to notify the Protime Clinic of patient hospitalizations and medication changes/discontinuation. However, the Protime nurse should be assessing the patients current history and medication at each visit. Stop and start orders for patients needing to go off Coumadin for a procedure of any kind, i.e., surgery, dental procedures, GI procedures, Cortison injections, etc., will be obtained by the ordering physician. If the Protime results are within the target or +.10 off the prescribed range in stable patients, the current dose will remain the same 6
7 Medication Refills Coumadin prescription refill requests are completed by the Protime Clinic Nurse, with refill orders called to the patient s pharmacy of choice on behalf of the ordering physician. Medication refills will be documented in the remarks column of the Anticoagulant Record (Ames) and in the Patient Education Progress Notes or on the Standing Stone Patient Progress Notes Report (Marshalltown). Recommended Standard Levels This is at the discretion of the treating Physician and under some circumstances (ie. Inherited coagulopathies) may be slightly different for some patients AFIB DVT PE Phlebitis CVA/TIA PFO PFO w/cva/tia Mechanical Valve Replacement Recurrent DVT/PE Visit Intervals (Rechecks shall be scheduled based on the following intervals): New Anti Caogulation Patient New patients to Coumadin will have their initial appointment within 3 5 days of starting Coumadin New patients will be rechecked every 3 7 days until 2 consecutive therapeutic readings have been obtained before lengthening the interval to 2 weeks, 3 weeks and finally 4 weeks at the discretion of the provider/protime If the patient is within normal range progress: 1 week 2 weeks 3 weeks 4 weeks If an adjustment is made, the INR will be checked in 2 weeks or less if therapeutic, the interval will increase to 3 weeks and then to 4 weeks Established Patients (Patients already on Anti Caogulation Therapy but New to the Protime Clinic): In most instances interval Protime levels are checked at least monthly. PCP order must be obtained when considering a longer recheck interval (ie medication stopped/dosage change) in the patient s schedule, the INR will be checked in2 weeks or less and if therapeutic the interval will increase to 3 weeks and then to 4 weeks. Table 1: Instructions Regarding Low INR Patient Range Patient Results Action Re Check < 1.0 *Contact PCP for Orders 3 Days 1 Week *Adjust 2 3 Days/Week 1 2 Weeks *Adjust 1 2 Days/Week 2 Weeks No Action Required 4 Weeks Patient Range Patient Results Action Re Check < 1.5 *Contact PCP for Orders 3 Days 1 Week *Adjust 2 3 Days/Week 1 2 Weeks *Adjust 1 2 Days/Week 2 Weeks No Action Required 4 Weeks * Without obvious reason: dosing will be adjusted accordingly by the educator when something in the patient s history explains why the INR is high/low 7
8 Table 2: Instructions Regarding HighINR Patient Range Patient Results Action Re Check >6.0 *Contact PCP for Orders As Directed by PCP *Adjust 1 3 Days/Week 3 Days 2 Weeks No Action Required 4 Weeks Patient Range Patient Results Action Re Check >7.0 *Contact PCP for Orders As Directed by PCP *Adjust 1 3 Days/Week 1 2 Weeks No Action Required 4 Weeks * Without obvious reason: dosing will be adjusted accordingly by the educator when something in the patient s history explains why the INR is high/low McFarland Clinic PC AMES Addendum: Protime Clinic Protocol Due to the volume of patients being followed by the Protime Clinic, any protimes done within 48 hours of notification to the Protime Clinic must be managed by the ordering physician. Patient Follow Up Reminder letters will be sent out weekly to patients who are due to have their INR checked. Non compliance letters are sent to patients monthly. The patient s ordering physician is notified if the patient is greater than 1 month overdue. Patients who are overdue after 2 months will be referred back to the ordering physician for management form that time on. The ordering physician is to notify the Protime Clinic of patient hospitalizations and medication changes/discontinuation. Patients needing to go off Coumadin for a procedure of any kind, (ie, surgery, dental procedures, GI procedures, Cortisone injections, etc.) will be referred to the ordering physician for stop and start orders. Patients with home monitoring machines are not eligible to be followed by the Ames Protime Clinic. Continued Documentation The service provided by the Ames Protime Clinic is documented on the Anticoagulant Record. This record is permanently located in the Ames Main patient chart. The encounter information is available to all ordering physicians utilizing the Ames Main chart on an as needed basis for management of the condition requiring Coumadin therapy. A copy of the Anticoagulant Record is faxed to all ordering physicians that do not have access to the Ames Main patient chart every 3 months for their use. The Anticoagulation Assessment column contains subjective patient information, ie, new medications or change in medication dosage(s), forgotten/missed Coumadin dose, bleeding, bruising, etc. The Meds. Education checkbox when checked indicates education was provided about medication changes, use of antibiotics, Tylenol, Advil, ASA, steroids, etc. The Nutrition Education checkbox when checked indicates Vitamin K instructions were reviewed, food listed provided, etc. The Bleeding Education checkbox when checked indicates education concerning bruising, bleeding, stools, urine, teeth, nose, caution against falls, cutting self, etc. was given. The first set of nursing initials defines the individual making medication adjustments and notifying the patient. The second set of nursing initials defines the individual charting the encounter. 8
9 McFarland Clinic PC Marshalltown Addendum: Protime Clinic Protocol Standard of Care Patient s results and treatment plan must be reviewed by the Primary Care Physician or the department s CALL doctor on the same day of the visit. If the PCP (or CALL Dr.) makes changes, they will notify the educator immediately. The educator will notify the patient within 24 hours of the visit. The Protime Nurse always has the opportunity to review results with the Primary Care Physician when there is a need to alter/not alter the does. Physicians may select certain patients for home monitoring machines. These will be evaluated case by case and eligibility for Protime Clinic nurse management will be assessed and determined on an individual case by case basis. Patient s who want to have a finger stick protime but will be managed by someone other than the protime clinic nurse can schedule appointments but will be handled in the following criteria: 1. A will not be charged. Charge for the protime blood test and fingerstick (if appropriate for their insurance) only. 2. The results will be faxed or delivered to the managing provider. The protime nurse will leave the dosing chart blank in the Standing stone system and on the pink flow sheet and will record in the notes that the patient s results and recommended dosing is being managed by another provider. Documentation The protime visit will be documented by printing the Standing Stone Patient Progress Notes Report and recording on the pink Anti coagulation Record (kept in the front of the Lab section). The Anti Coagulation Record will be completed according to the How to Use the Anti Coagulation Record. The Educator will check the box See Standing Stone Report from protime nurse visit in the Remarks section to indicate there is other information for that encounter. Additional notes from the educator will be added to the remarks section of the pink anti coagulation record. If there is not adequate room, notes may be written/typed on the bottom of the Standing Stone Patient Progress Notes Report. If the patient has not taken the prescribed amount of medication since the previous visit, the actual dose taken can be manually entered on the Standing Stone Patient Progress Note Report The Patient Education stamp will be used ini the PCP s progress notes to indicate an education appointment has occurred. The date of the visit will be recorded in front of the stamp. PT (protime) or DM (Diabetes) will be written after the stamp to indicate the type of visit. The Medication Flow sheet will be reviewed, revised and documented according to the How to Use the Medication Flow Sheet policy at each visit and it will be recorded on the pink Anti coagulation flow sheet in the Remarks section (ie Med list updated or Med list Ø from (previous visit date).) Medication refills approved by protocol by the nurse educators will be documented on the Patient Education progress note or if done during a protime clinic appointment, may be recorded on the Standing Stone Patient Progress Note Report. The chart will be routed to the patient s PCP for initialing. The education routing slip will be clipped to the front of the chart. The Standing Stone Patient Progress Note will be placed in a plastic see through folder inside the front of the chart. The PCP will initial the Standing Stone Patient Progress Note Report. The PCP s initials indicates review of the Standing Stone Patient Progress Notes Report, the pink anticoagulation record and indicates agreement with the plan of care. This is done to assure the PCP agrees with the care and to meet the billing requirements. The chart can then be returned to Medical Records. Also refer to the How to Use the Anti Coagulation Record policy found in the Marshalltown Medical Records Handbook Patient Follow Up A list of overdue patients will be run on the Standing Stone reporting system every 2 weeks A phone call will be made to non compliance patients on a monthly basis (check schedule to verify they do not have an upcoming appointment) Non compliance letters will be sent after 2 attempts to notify the patient by phone If the patient is unwilling to re schedule appointments after 2 months, the nurse will notify the ordering physician and the patient will be referred back to the ordering physician for management 9
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