Table 1.
Category | Characteristic in E-LITE | Applicability for translation into real-world practice (good, fair, or poor) |
---|---|---|
Reach (identification, recruitment, and representativeness of participants) | ||
Methods of identification | Use of EHR to identify candidate patients | • Fair to good–applies well to clinics with EHR capabilities, which are growing in number |
Target population size | 3880 patients identified in initial search of clinic EHR with PCPs approving 3520 for further evaluation | • Good–obesity/overweight is highly prevalent within a single clinic |
Risk factors | Patients with obesity/overweight and also cardiometabolic risk factors (pre-diabetes and/or metabolic syndrome) (Table 2) | • Good–for low-cost measurements (e.g., BMI) |
• Fair–for lab-based criteria (e.g., cholesterol panel) and some clinical measurements, because are more costly or are not routinely performed but also are readily available | ||
Recruitment strategies | Mailed letter as first invitation contact 1st stage of screening performed either online or by phone Of those patients ultimately randomized over half completed the initial screening online | • Good–for letters, because cheap and easy to do |
• Fair to good–for online contact, as this kind of contact with patients is growing and increasingly applicable in the real world | ||
• Fair–for phone calls, because more costly/labor intensive | ||
Eligibility and ineligibility | 22% of those screened were determined to be eligiblea (Fig. 1) 88% of ineligibility determinations were due to reasons likely to apply in the real world. (Table 3) | • Fair–acceptable distribution of ineligibility reasons that have face validity and are easy for patients/physicians to determine |
Participation rate | Conservative estimate = 44%b (Fig. 1) More liberal estimate = 98%b | • Fair–reasonable when compared to RCTs in which conservative participation rates were calculated |
Participants vs. non-participants | Age, sex, and race/ethnicity data demonstrate no compelling differences in demographics, with the possible exception of older and white patients being overrepresented (Table 2) | • Fair–no strong selection bias by demographics |
Adoption (research interface with potential program settings) | ||
Setting | Single private, urban primary care clinic with all PCPs agreeing to participate | • Fair to good–applies well to private, urban clinics but less well to others |
Intervention modalities | Group classes and DVDs with parallel content; EHR secure messaging system; AHA online portal of self-management tools | • Good–for group classes, which are commonly used in many clinic settings |
• Fair–for DVDs, EHR messaging, and use of online portal, because these require personal IT access and skills. However, use of DVDs and online interactions/tools with patients is growing in frequency and is increasingly applicable in real world settings | ||
Resource requirements | Research staff with intervention training and materials provided by the DPSC | • Fair–applicable to clinics that can allocate resources for personnel trainingc/materials but not applicable to other clinics |
Organizational diffusion/spread | 100% of providers at intervention site agreed to participate Modified version of group-based intervention has been adopted by the health network of which the study clinic is a part | • Fair to good–applicable at local study clinic and modified group-based intervention adopted early by health network, but latter lacks certain components of intervention (i.e., search of clinic EHR, online screening, EHR secure messaging, use of AHA portal) so is unclear how these intervention components will apply |
E-LITE = Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care. EHR = electronic health record. PCP = primary care provider. DVD = digital versatile disc. AHA = American Heart Association. DPSC = Diabetes Prevention Support Center. BMI = body mass index (kg/m2).
Based on eligibility determinations for those patients who underwent full screening processes: (eligible)/(ineligible+eligible).
The conservative estimate of participation rate uses the Glasgow et al. approach [25]: participation rate=(number of participants who were randomized)/(number of participants for whom contact was attempted and eligibility was assumed or confirmed). The more liberal estimate is the percent of patients who were eligible who then became participants.
Personnel training currently costs $275 for the 2-day training program provided on-site at the Pittsburgh DPP Support Center.