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Abstract #163374

Michelle Elicia Ulmer, BA¹, Donald Robinaugh, BA², Jennifer P. Friedberg, PhD³, Ashley Regazzi², and Sundar Natarajan, MD, MSc¹. (1) Research and Development Service, Department of Veterans Affairs New York Harbor Healthcare System & New York University, 423 E 23rd Street, 13109C, New York, NY 10010, 212-686-7500 x7927, michelle.ulmer@va.gov, (2) Research & Development Service, VA New York Harbor Healthcare System, New York Campus, 423 East 23rd St., New York, NY 10010, (3) Research & Development Service (151), VA New York Harbor Healthcare System/New York University School of Medicine, 423 East 23rd St., New York, NY 10010

Dropouts reduce the validity of results obtained from randomized clinical trials (RCT). Thus it is critical to retain patients once randomized. We evaluated the usefulness of a run-in period to reduce the number of dropouts in a behavioral intervention to improve blood pressure. In the pilot study where a run-in period was not used, we had a 29% dropout rate. A prospective evaluation was performed in the context of a 3-arm RCT. Patients are approached during a routine visit, informed about the study, and invited to participate if eligible. After a 1-month run-in period, patients return for a baseline visit. They are then randomly assigned to the usual care, health education intervention, or stage of change matched intervention groups. Participants are followed for 1 year (they make 4 total visits). We identified 3646 potential participants by medical record review of which 2730 made the actual visit. Of these 2730, 1181 were interested enough to get detailed information about the study; the remaining were not interested (82), had no time (119), were missed (679), or were ineligible (669). Of the 1181 informed, 279 consented, and 188 were subsequently enrolled. Prior to the baseline visit, 49 patients withdrew consent, 100 were randomized and 4 dropped out. In our study to date, while our cancellation rate is 26%, our drop out rate is only 4%. This is much better than most behavioral trials. We believe that the run-in period has allowed us to reduce the number of dropouts after randomization.

Learning Objectives:

• 1) Recognize issues due to participant dropout in clinical studies
• 2) Articulate the differing strategies needed for recruitment versus retention
• 3) Describe ways to improve participant retention
• 4) List patient flow in a behavioral clinical study

Keywords: Behavioral Research, Hypertension

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.