Table 1.
Variables, outcomes, and process measures | Definition | Rationale | |
Independent variables | |||
|
Basic demographics | Age, gender, race and ethnicity, language, and insurance | Assess patient population |
|
Diagnoses | Atrial fibrillation, atrial flutter, stroke, DVTa, mitral valve replacement, atrial valve replacement, pulmonary arterial hypertension, and PEb | Assess prevalence of indications for anticoagulation |
|
SAMe-TT2R2 score (sex, age, medical history, treatment, tobacco use, and race) | A clinical scoring system designed to predict which patients on oral vitamin K antagonists (eg, warfarin) will reach an adequate TTRc (>65%-70%) | Assess baseline likelihood of achieving/maintaining anticoagulation control |
Outcomes | |||
|
TTR | Days in range divided by total days on warfarin | Assess overall treatment efficacy |
|
Proportion in range | INRd values in range divided by total INR values measured | Secondary measure of treatment efficacy |
|
TWTRe | Days from first administration of warfarin to first therapeutic INR value | Assess efficiency of achieving therapeutic control |
Process measures | |||
|
Time from out-of-range INR value to patient contact | Days until patient outreach after abnormal INR value | Assess responsiveness of the clinic to abnormal values |
|
Attendance rate to scheduled visits | Proportion of visits attended (completed visits divided by scheduled visits) | Assess efficiency of clinical operations |
|
Proportion of patients meeting monitoring guidelines | Proportion of patients who receive regular 56-day monitoring | Assess adherence to treatment guidelines (ie, nomogram) |
|
Appropriate duration of therapy | Observed duration (days) of anticoagulation therapy divided by recommended total duration | Assess the extent of overtreatment |
|
Provision of telephonic or other remote visit for anticoagulation managementf | Proportion of patients transitioned from in-person to phone visits (related to TWTR) | Assess adherence to workflow protocol and overall clinic performancef |
|
DOACg transitions | Proportion of eligible patients screened and/or transitioned to DOACs | Assess adherence to screening and transition protocols |
Other clinical outcomes | |||
|
Bleeding complications | Incidence of bleeding during treatment | Assess the incidence of adverse events |
|
DVT | Incidence of DVT during treatment | Assess the incidence of adverse events |
|
PE | Incidence of PE during treatment | Assess the incidence of adverse events |
|
Ischemic stroke | Incidence of stroke during treatment | Assess the incidence of adverse events |
aDVT: deep venous thrombosis.
bPE: pulmonary embolism.
cTTR: time in therapeutic range.
dINR: international normalized ratio.
eTWTR: time from warfarin initiation to first therapeutic INR.
fThe workflow protocol recommends that patients with international normalized ratio values consistently in range must be transitioned from in-person to telephone visits. If the intervention is effective, we would expect an increase in patients switched to remote telephonic monitoring.
gDOAC: direct-acting oral anticoagulant.