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Table 1 Trial arms and interventions

From: Evaluating the clinical utility of early exome sequencing in diverse pediatric outpatient populations in the North Carolina Clinical Genomic Evaluation of Next-generation Exome Sequencing (NCGENES) 2 study: a randomized controlled trial

Arm

Interventions

Experimental:

PVP / ES + usual care

Participants randomized to pre-visit preparation (PVP) will receive a study packet with educational materials and a question prompt list (QPL) before their clinical interactions (e.g., clinic visit or return of diagnostic/clinical test results). These participants will be instructed to review the materials, use the QPL to select questions they would like to ask at their clinic visit, and use the QPL during clinical interactions.

Participants will be offered research exome sequencing (ES) in addition to their usual clinical care.

Experimental:

PVP / usual care

Participants randomized to PVP will receive a study packet with educational materials and a QPL before their clinical interactions (e.g., clinic visit or return of diagnostic/clinical test results). These participants will be instructed to review the materials, use the QPL to select questions they would like to ask at their clinic visit, and use the QPL during clinical interactions

Participants will not be offered research ES but will receive usual clinical care.

Experimental:

No PVP / ES + usual care

Participants in the no PVP arm will be mailed a study packet reminding them about their upcoming clinic visit.

Participants will be offered research ES in addition to their usual clinical care.

Control:

No PVP / usual care

Participants in the no PVP arm will be mailed a study packet reminding them about their upcoming clinic visit.

Participants will not be offered research ES but will receive usual clinical care.

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Trials

ISSN: 1745-6215