Plans to promote participant retention and complete follow-up {18b}
RECRUITMENT
To support retention of study participants after discharge, sites are instructed to use any retention resources at their institution including follow-up clinics and other similar resources. Sites should update contact information at every study follow-up timepoint. Participants will receive $50 compensation for each follow-up timepoint (1 month post-discharge, 6, 12, and 18 months) except 24 months, at which they will receive $100. Each site should use the appropriate type of participant reimbursement at their hospital. It is critical to keep participants informed and engaged during their participation in the study. Make sure that all of the contact timepoints are clearly communicated with each participant. After a participant enters the study, the site can follow up with a thank you note. Sites may also use text messaging to keep in contact with participants to update contact information and send reminders. Sites should check hospital records for updated contact information if they are unable to reach the participant by text, email, phone, or letter. Sites should document every attempt to contact a participant. More frequent contacts with the care giver (phone, text, email, etc.) in between study follow-up time points is encouraged but left to the discretion of the participating hospital. To maximize success rate in follow-up, it is recommended that participants are contacted/seen as early as possible in the following time windows:1 month post-discharge: ± 3 weeks6, 12 and 18 months: ± 6 weeks24 months: 22–28 months. If an appointment was made for a 24-month evaluation prior to 28 months, the data will be used provided the evaluation is performed prior to 30 months.Follow-up personnel/coordinators should anticipate that it will take multiple attempts to reach the caregiver. Attempts to contact a participant should be made on different days/times for a particular follow-up timepoint. If a family is unable to be contacted during one of the designated follow-up periods, they should be contacted again during the next follow-up period. If contact is made via telephone, and the family has limited time available for questionnaires, questionnaires should be administered in the following order:1 month post-discharge: PROMIS, MPAQ, CQ6 months: CQ12 months: CQ18 months: CQ24 months: Bayley-4, BITSEA, PROMIS, CQFollow-up programs should anticipate that multiple attempts to establish contact will be necessary. If the site research team is having difficulty contacting a participant, the number of continued attempts should be discussed with the participating site/hospital PI. Regular meetings of the site/hospital research team and those involved in follow-up may be of benefit to devise strategies to maximize retention.Critical to maintaining compliance for follow-up visits is the contact form collected during the recruitment period. The contact form incorporates information including the address and phone contacts of the parent/caregiver, as well as any other person listed as additional contacts. At the initial visit with the parent/caregiver and on all subsequent visits, contact information should be reviewed and updated. Two-way communication with the family needs to be implemented at each site through the parent’s preferred method of communication(s) including, telephone calls, text messages, emails, and face-to-face interactions. Seasonal/birthday cards, mailings, and/or newsletters are encouraged because it keeps participants engaged, as well as provides address verification. Returned mailings should be updated in the tracking system. The use of private messages, similar to email, may be allowed and an effective tracking tool when other contact information is no longer in use.Before hospital discharge, the study team should obtain information from the mother or other caregivers so that other relatives or friends could be contacted to find the family’s new address if they had moved. It is important that families and caregivers be made aware that any information regarding address or phone number remain strictly confidential and will not be shared with anyone for any other purpose but making appointments for the infants’ benefit.