Implementing comprehensive data collection strategies within a randomized control trial for children with complex special health care needs

Background: Measuring effectiveness of an intervention in a randomized controlled trial is dependent on maximum response rates from subjects over time. TeleFamilies is a 4-year study testing the effectiveness of APRN care coordination on health outcomes of children with complex special health care needs (CCSHCN). The results of innovative strategies for increasing response rates from 164 subjects in the TeleFamilies study are presented.

Methods: The primary outcome is healthcare service utilization (HCSU); secondary outcomes include quality of life and satisfaction data collected annually during the study. Parents were asked to collect HCSU, which included clinic visits, ED visits and hospitalizations, on a standardized form to mail back each month over the 30 month enrollment period. Realizing families had limited time and energy for monthly form completion, strategies expanded from monthly mail-in forms to telephone, email, text messaging, medical record review and in-person contact at clinic visits. A 25% research assistant was added for monthly collection of HCSU by telephone. Annual surveys were mailed with stamped return envelopes and an introductory letter.  Low return rates prompted incorporation of all Dillman’s Tailored Design Method strategies including pre- and post- mailing reminders, ‘return by’ dates, telephone reminders, revision into user-friendly survey booklet and monetary incentives. 

Results: Over a two year period, over 3700 calendar forms were distributed and monthly data collection increased from 85% to 96%.  Annual survey returns rates increased from 62% to 86%, with a significant increase in survey return rate when the incentive was used (p<.05).

Conclusion: Families of CCSHCN have complex and competing demands on their time. Offering alternative methods of data collection supports the study relationship while being respectful of family time. Increased FTE support and comprehensive, flexible data collection strategies resulted in high levels of data retrieval which contribute to the reliability of TeleFamilies outcome measures.