Table 1.
PRECIS‐2 domains and pragmatism assessment for the design of the I‐PICC Study
| Domain | Domain description | Assessment of pragmatism | Rationale for PRECIS‐2 scoring of I‐PICC Study | Score |
|---|---|---|---|---|
| Eligibility | Specifies inclusion and exclusion criteria for the trial and frames the target population(s) for which its results are intended to apply | Are participants in the trial similar to those who would receive the intervention if it were available in usual care? | All primary care and women's health providers with prescribing privileges, except residents, are eligible for participation. Patient eligibility criteria are overall rather inclusive of the majority of patients for whom preemptive SLCO1B1 testing would be relevant if it were available in usual care. | 4 |
| Recruitment | Outlines the steps for the identification, consent, and enrollment of participants into the trial | How much extra effort is made to recruit participants into the trial above what would occur in usual care? | The trial leverages available data, informatics, and clinical resources at VABHS to recruit and enroll participants in the context of primary care. Recruitment effort is minimally greater than what occurs in usual care, including use of the EHR to consent providers and enroll patients and the sending of a recruitment letter and brief consent telephone call (< 5 minutes) to patients. | 4 |
| Setting | Context under which the trial is carried out, including factors such as geographic location and clinical infrastructure of the study site(s) | How different is the setting of the trial and the usual care setting? | The trial embeds SLCO1B1 genetic testing into eight VABHS women's health and primary care sites across eastern Massachusetts. The resources, clinical infrastructure, and reach of primary care services at VABHS are comparable to those found in other typical large healthcare systems. | 4 |
| Organization | Structure and delivery of the intervention, including the clinical resources required to provide the intervention | How different are the resources, provider expertise, and organization of care delivery in the intervention arm of the trial and usual care? | Beyond the intervention, there is no difference between the delivery of care in the trial and usual care. No specialized training is administered to providers, no additional clinical staff is required, and study staff integrated the intervention into the EHR and primary care setting using available data, informatics, and clinical resources. | 5 |
| Flexibility in delivery | How the trial intervention is delivered to study participants | How different is the flexibility in how the intervention is delivered and the flexibility likely in usual care? | No specified protocol is used for the delivery of SLCO1B1 test results. Providers receive structured results and clinical interpretation and prescription recommendations via the EHR per standard practice, are encouraged to communicate results to patients, and are provided with a standardized results letter template to do so. Nonetheless, the decision whether and how results are used and delivered to each patient is left entirely to the provider. | 5 |
| Flexibility in adherence | How closely study participants are monitored for compliance to the trial intervention and the measures used to maintain or improve adherence | How different is the flexibility in how participants must adhere to the intervention and the flexibility likely in usual care? | Participant adherence to the study intervention is not monitored or required. Provider adherence to CPIC guidelines for statin prescribing is encouraged but not protocolized (secondary outcome). Patients may adhere or not to any clinical recommendation associated with his or her SLCO1B1 test result. | 5 |
| Follow‐up | The rigor of measurement and amount of contact between the study staff and trial participants for the purposes of event tracking and data collection | How different is the intensity of follow‐up of participants in the trial and the likely follow‐up in usual care? | The intensity of participant follow‐up is minimally greater than what might occur in usual care. Providers receive no contact beyond notification of their patients' SLCO1B1 results. The 12‐month patient outcomes are collected observationally through the EHR, except for a brief end‐of‐study telephone survey (< 5 minutes). The majority of participant data are collected through the EHR via structured clinical data, chart review, and tracking of providers' use of study features in the EHR. | 4 |
| Primary outcome | The main variable to be measured for use in assessing the effect of the study intervention | To what extent is the trial's primary outcome relevant to participants? | The primary outcome is change in LDL‐C (12‐month LDL‐C minus baseline LDL‐C). LDL‐C is a clinically relevant biomarker, and well‐validated proxy for CVD risk. As a surrogate, it is not immediately relevant to patients, but is considered exceptionally meaningful to providers and policymakers. | 3 |
| Primary analysis | The approach used for the analysis of final results | To what extent are all data included in the analysis of the primary outcome? | The primary outcome will be analyzed using an intention‐to‐treat approach. No participant data will be excluded on the basis of intervention compliance or recruitment volume thresholds (i.e., a provider who signed only one order). | 5 |
Adapted from Ford and Norrie 201610 and Loudon et al. 201515. Domain scores range from 1 (very explanatory) to 5 (very pragmatic).
CPIC, Clinical Pharmacogenetics Implementation Consortium; CVD, cardiovascular disease; EHR, electronic health record; I‐PICC, Integrating Pharmacogenetics in Clinical Care; LDL‐C, low‐density lipoprotein cholesterol; PRECIS‐2, PRagmatic‐Explanatory Continuum Indicator Summary 2; VABHS, Veterans Affairs Boston Healthcare System.