links.lww.com/PCC/B49

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Supplemental Table 1: Strategies and Advice to Site Research Personnel regarding Follow-up

Objective Delivery Method Timing Trainers Content

Initial Study Team Engagement

Create Study Context

 In-person meeting

 Webinar

Before Sites Go Live  Study Principal

 Investigators

 DCC

 KKI

 Discuss scientific rationale for study and potential impact study could have on patient population.

 Emphasize consequences of lost to follow-up on primary outcome

 Orient study teams to detailed protocol and procedures

Ongoing

Communication and Connection

 In-person Meeting

 Open Forum discussion (calls, webinars)

 Yearly

 Ongoing

 DCC  Pair up experienced

coordinators with new coordinators as buddies and advocates.

 Informal discussions at in- person meetings

 Newsletters  Monthly  Includes study protocol info,

site spotlights, and including VABS-II completion strategies and advice.

 Electronic queries

 2- and 11- months

 Reminds sites to start contacting family to meet the 3- and 12-month milestones.

Strategies for ongoing follow-up completion

 In-person

 Group and Individual site Phone Calls

 Yearly

 Ongoing

 DCC

 KKI

 Set-up follow-up phone call far in advance such as at hospital discharge

 Call family on different days of week and times of day

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 Remind families that the call will be coming from a Baltimore area code

 Inform the family of the KKI RA’s name so they know from whom to expect the call

 Inform KKI RA of any relevant family issues (patient’s upcoming surgery, family stressors) that might impact timing of follow-up call.

Strategies for

Addressing Challenging Follow-ups

 In-person

 Group and Individual site phone calls

 Yearly

 Monthly PI and RC meetings;

 Individual site phone calls as needed

 DCC

 KKI

 If the numbers on file are not working (disconnected, wrong number, etc.) look for numbers in alternate places.

 Check social work notes

 Check for upcoming

appointments; set up follow- up call time for when child will be at the hospital for an appointment.

 If IRB approves, send certified letter with RC contact info with copy of signed consent to remind family of agreement to participate in follow-up study procedures.

Maximizing Accountability

 Group phone calls

 Monthly PI, RC and EC meetings

 DCC

 KKI

 Keep all study staff and stakeholders regularly informed of ongoing follow- up rate.

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Discuss dropping primary outcome rate with individual sites.

Maintaining Commitment and Enthusiasm

 Invoice

 Annual awards ceremony

 Personal handwritten thank-you notes

 Yearly in- person meeting or webinar

 Ongoing

 DCC  Significant financial

reimbursement to site when primary outcome completed

 Recognition for a job well-

 doneMailed letters and certificates

(DCC) Data Coordinating Center, (KKI) Kennedy Krieger Institute