Examining the external validity of the CRUZA study, a randomized trial to promote implementation of evidence-based...

The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control. This paper examines the external generalizability of the CRUZA study findings by comparing characteristics of parishes that agreed to participate in the intervention trial versus those that declined participation. Sixty-five Roman Catholic parishes that offered Spanish-language mass in Massachusetts were invited to complete a four-part survey assessing organization-level characteristics that, based on the Consolidated Framework for Implementation Research (CFIR), may be associated with EBI implementation. Forty-nine parishes (75%) completed the survey and were invited to participate in the CRUZA trial, which randomized parishes to either a "capacity enhancement intervention" or a "standard dissemination" group. Of these 49 parishes, 31 (63%) agreed to participate in the trial, whereas 18 parishes (37%) declined participation. Parishes that participated in the CRUZA intervention trial were similar to those that did not participate with respect to "inner organizational setting" characteristics of the CFIR, including innovation and values fit, implementation climate, and organizational culture. Change commitment, a submeasure of organizational readiness that reflects the shared resolve of organizational members to implement an innovation, was significantly higher among the participating parishes (mean = 3.93, SD = 1.08) as compared to nonparticipating parishes (mean = 3.27, SD = 1.08) (Z = -2.16, p = .03). Parishes that agreed to participate in the CRUZA intervention trial were similar to those that declined participation with regard to organizational characteristics that may predict implementation of EBIs. Pragmatic tools to assess external generalizability in community-based implementation trials and to promote readiness among faith-based organizations to implement EBIs are needed to enhance the reach and impact of public health research. Clinical Trial information: The CRUZA trial identifier number with clinicaltrials.gov is NCT01740219.