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Table 2 Schedule of forms and procedures (adapted from original SPIRIT table)a

From: The TeleKidSeq pilot study: incorporating telehealth into clinical care of children from diverse backgrounds undergoing whole genome sequencing

 

Study period

Time point

 

 − 3–0 months

BL (0 months)

ROR1 (3

months)

ROR2 (9

months)

Activity/assessment

Staff 

member

Referral/

eligibility

screening

Randomization

Baseline

survey

Pre-test

genetic

counseling

Sample

collection

Results

disclosure

6-month

follow-up

Receipt of referral

Study

coordinator

X

      

Pre-screening of referral

Study

coordinator/

genetic

counselor

X

      

Screening and scheduling of baseline visit

Study

coordinator

X

      

Randomization

Study

coordinator

 

X

     

Baseline survey informed consent

Study

coordinator

  

X

    

Administration of baseline survey

Study

coordinator

  

X

    

Pre-test genetic counseling

Genetic

counselor

   

X

   

Main study informed consent

Genetic

counselor

   

X

   

Sample collection for GS

Study

phlebotomist/participants at home

    

X

  

Receipt of results/genetic counselor preparation for ROR1

Genetic

counselor

     

X

 

Disclosure of results (ROR1)

Genetic

counselor

     

X

 

Administration of ROR1 survey

Study

coordinator

     

X

 

Administration of ROR2 survey

Study

coordinator

      

X

  1. aRecommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols