Impact of local changes in clinic and study practices on retention of opiate-dependent participants in a multi-site clinical trial

Participant recruitment and retention are critical to the validity of clinical trial findings. One year into a three year multi-site clinical trial, a narcotic treatment program modified recruitment and retention processes: a) recruitment strategies expanded, b) research staff worked more closely with intake personnel, c) physician involvement increased through staff meetings, study medication dosing changes and national training, d) a dedicated counselor was assigned to study participants and e) patient financial barriers were removed. Integration of the research project into clinic operations fostered ownership in the trial. Data were analyzed from two four month periods before (October 2006 to January 2007) and after (October 2007 to January 2008) the restructuring to assess impacts on recruitment and retention. There were no changes in clinic population for gender, age, race, or type of opiate addiction. Prior to reorganization, 39 individuals were screened, 23 (59%) screen-failed, 16 individuals were randomized and 6 (38%) of those were retained for four months. After reorganization, 19 individuals were screened, 2 were screen-failures (11%), 17 (89%) were randomized and of those, 11 (65%) were retained for four months. Although more than twice as many individuals were screened in the period prior to re-organization, 83% more were retained in the latter period. The specific procedural changes and further analyses associated with this improved recruiting efficiency and retention will be described and discussed.