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PILOT STUDY PRAGMATIC DESIGN WORKSHEET INSTRUCTIONS (Required for Full Proposals): Use the suggested criteria to score your proposed intervention/design element as either low (L, not ready/pragmatic), medium (M, partially ready/pragmatic), or high (H, mostly ready/pragmatic) and describe the design element and rationale for your score in fewer than 100 words. Your pilot study must set the foundation for a full embedded pragmatic trial, and thus must reflect pragmatic trial design features. Please read the Readiness Assessment for Pragmatic Trials (RAPT) model and the PRECIS-2 framework for additional guidance and definitions of these domains, which we have tailored slightly for the purposes of pilot studies and this worksheet.

DOMAIN ADAPTED FROM RAPT MODEL PLEASE DESCRIBE AND PROVIDE RATIONALE FOR SCORE

1. IMPLEMENTATION PROTOCOLIs the intervention protocol sufficiently detailed to be replicated?

☐L There is no protocol.

☐M The protocol provides some documentation, but may bedifficult to replicate.

☐H The protocol is well documented and is likely to bereplicated.

2. EVIDENCETo what extent does the evidence base support the intervention’sefficacy?

☐L There are no efficacy studies or the efficacy studies didnot use rigorous methods (e.g., a RCT).

☐M A single study using rigorous methods demonstratedefficacy.

☐H Multiple studies using rigorous methods havedemonstrated efficacy.

3. RISKDo we know how safe the intervention is?

☐L The risks (harms and discomforts) are unknown or are known to be more than minimal (e.g., greater thanordinarily encountered in daily life).

☐M The risks are unknown, but are likely minimal.

☐H The risks are known to be minimal.

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4. FEASIBILITYTo what extent can the intervention be implemented underexisting conditions (i.e., implemented in usual clinical workflow ofthe health care system)?

☐

☐H Implementation is possible with existing resources and in the existing workflow.

5. MEASUREMENTTo what extent can the primary clinical outcome be capturedusing electronic health care system or administrative data (e.g.,electronic health records, Medicare data, widely used surveys suchas CAHPS)?

☐L Outcomes cannot be captured without majormodifications to systems or increases in staff time.

☐M Outcomes can be captured with minor modifications tosystems or increases in staff time.

☐H Outcomes are already routinely captured.

6. COSTHow likely is the intervention to be economically viable?

☐L Cost-benefit/cost-effectiveness analysis has not beencompleted (formally or informally) and it is unknown whether benefits outweigh costs.

☐M Cost-benefit/cost-effectiveness analysis has not beencompleted, but benefits are likely to outweigh costs.

☐H Cost-benefit/cost-effectiveness analysis demonstratesbenefits outweigh costs.

M Minor modifications to existing resources or workflow would enable implementation.

L Resources or workflow changes necessary for implementation (e.g., staff, infrastructure, payment) are absent or insufficient.☐

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7. ACCEPTABILITYHow willing are health systems, frontline providers, patients/families, and other internal stakeholders likely to be to adopt this intervention?

☐L Acceptability is unknown or staff are unlikely to believe the intervention is feasible or needed.

☐M Acceptability is unknown, but staff are likely to believethe intervention is feasible or needed.

☐H Acceptability is known and staff believe the interventionis feasible and needed.

8. ALIGNMENTTo what extent does the intervention align with key stakeholders’priorities?

☐L Stakeholders (policymakers, payors, advocates and others) do not believe the intervention addressesa current or anticipated priority.

☐M Some stakeholders believe the intervention addresses apriority.

☐H Most or all stakeholders believe the interventionaddresses a priority.

9. IMPACTHow useful will the results be?

☐L Providers, patients/families and other stakeholders(e.g., policymakers, payors, advocates) are unlikely tobelieve that the outcomes are useful (e.g., to inform clinical care or policy).

☐M Some providers or stakeholders are likely to believe theoutcomes are useful.

☐H Most or all providers and stakeholders are likely tobelieve the outcomes are useful.

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10. CONSENTCan the pragmatic trial be accomplished with a waiver ofindividual consent in accordance with Federal regulation 45 CFR§46.116(f)(3)(i.-v.)?

☐L The study will require individual informed consent.

☐M The study is designed such that approval for analteration of consent is anticipated.

☐H The study is designed such that approval for a waiver ofconsent is anticipated.

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PILOT STUDY PRAGMATIC DESIGN PRECIS-2 WORKSHEET INSTRUCTIONS: Use the suggested criteria to score your proposed intervention/design element as to how explanatory or pragmatic these elements are for your pilot study. Please rate on a 3-point scale from L (explanatory), M (equally pragmatic/explanatory) or H (pragmatic) and describe the design element and rationale for your score in fewer than 100 words. Your proposed pilot study MUST BE PRAGMATIC. Please read the PRECIS-2 framework for guidance and definitions of these domains.

DOMAINS FROM PRECIS-2 PLEASE DESCRIBE AND PROVIDE RATIONALE FOR SCORE

1. ELIGIBILITYTo what extent are the participants in the trial similar to thosewho would receive this intervention if it was part of usual care?

☐L Eligible participants reflect a highly select group definedby narrow inclusion criteria with multiple exclusion criteria.

☐M Eligible participants reflect a select group defined byrelatively broad-based inclusion criteria with select exclusion criteria.

☐H Eligible participants reflect those seen in usual caredefined by broad-based inclusion criteria and limited exclusion criteria that only apply when an intervention may be unsafe or not appropriate.

2. SUBJECT IDENTIFICATIONTo what extent can subject identification be accomplished usingexisting health care system electronic data infrastructures (e.g.,electronic health records, administrative/billing data)?

☐L Subject identification will require substantial augmentation to existing health care system electronic data infrastructure and/or resources.

☐M Subject identification will require modest augmentationto existing health care system electronic data infrastructure and/or resources.

☐H Subject identification can be completely accomplishedusing existing health care system electronic data infrastructure and/or resources.

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3. SETTINGHow different is the setting of the trial from that of the usual caresetting?

☐L Intervention will be delivered in highly specialized sitesor local sites that perform research procedures routinely.

☐M Intervention will be delivered in a mix of specialized andmore common local sites that have limited generalizability.

☐H Intervention will be delivered in sites where usual care isgenerally provided or diverse settings that are highly generalizable.

4. IMPLEMENTATION DELIVERYTo what extent can the intervention be delivered with the usualorganization and resources of the health care system?

☐L Intervention delivery will require substantial changes to the usual organization and augmentation of existing resources of the health care system.

☐M Intervention delivery will require modest changes to theusual organization and augmentation of existing resources of the health care system.

☐H Intervention delivery will require minimal changes tothe usual organization and augmentation of existing resources of the health care system.

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5. FLEXIBILITY (delivery)How flexible is the delivery of the intervention?

☐L Intervention delivery is rigidly prescriptive and must beperformed in a highly specific manner with minimal variation by clinical site or staff.

☐M Some components of intervention delivery are highlyprescribed, but others are flexible.

☐H Most components of intervention delivery are flexibleand can be varied by clinical site or staff.

6. FLEXIBILITY (adherence)How flexible is participant adherence to the intervention?

☐L Participants must closely adhere to all interventioncomponents and special measures are needed to enforce engagement or compliance.

☐M Participants can adhere to some of the interventioncomponents but others are flexible. Some measures may be used to increase engagement or compliance.

☐H Participants have flexibility in adherence to mostintervention components and no measures are needed to enforce engagement or compliance.

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7. FOLLOW-UPHow closely are participants followed up?

☐L Follow up visits are required and clearly prescribed aspart of the trial protocol.

☐M Some additional follow-up is required but can be addedonto usual care processes (e.g., longer clinical visit, complete of survey at physician visit).

☐H Follow-up is part of usual care and does not requireadditional visits outside of usual care processes.

8. PRIMARY OUTCOMETo what extent is the trial's primary outcome relevant toparticipants and collected as part of usual care?

☐L The primary outcome is most important to researcherseither as a surrogate or endpoint and less important to participants; the outcome is not normally collected as part of usual care.

☐M The primary outcome may be a composite where someare more important to participants than others; the outcome is more important to clinicians than participants or is more important at a later time point in care than would occur under usual circumstances; outcome is not routinely collected in usual care but could be collected with modifications.

☐H The primary outcome is highly important to participantsand can be collected pragmatically as part of usual care processes.