Brief Methodological Reports
Predicting Nursing Home Adherence to a Clinical Trial Intervention: Lessons for the Conduct of Cluster Randomized Trials
Article first published online: 31 OCT 2011
© 2011, Copyright the Authors Journal compilation © 2011, The American Geriatrics Society
Journal of the American Geriatrics Society
Volume 59, Issue 12, pages 2332–2336, December 2011
How to Cite
Tjia, J., Mazor, K. M., Field, T., Doherty, P., Spenard, A. and Gurwitz, J. H. (2011), Predicting Nursing Home Adherence to a Clinical Trial Intervention: Lessons for the Conduct of Cluster Randomized Trials. Journal of the American Geriatrics Society, 59: 2332–2336. doi: 10.1111/j.1532-5415.2011.03697.x
- Issue published online: 20 DEC 2011
- Article first published online: 31 OCT 2011
- National Institute on Aging. Grant Numbers: K08 AG021527, R01 HS016463
- Agency for Healthcare Research and Quality. Grant Number: R01 HS016463
- cluster randomized trials;
- run-in period;
- intervention trials
To describe factors predictive of nursing home (NH) adherence to a clinical trial intervention.
Post hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse–physician telephone communication in NHs.
All eligible licensed nursing staff in all participating NHs.
Adherence was defined as active participation for at least 3 months of the 12-month trial. NH characteristics hypothesized to affect trial outcomes (profit status, bed size, nursing staff time, NH quality, and leadership turnover) were measured a priori. The association between intervention adherence, NH characteristics and preintervention questionnaire response rate was examined.
Of 13 intervention NHs, seven adhered to the intervention. Three factors differentiated adherent from nonadherent NHs: director of nursing turnover (nonadherent NHs 50% vs adherent NHs 0%, P = .03); Centers for Medicare and Medicaid Services (CMS) nurse staffing rating (range: 1–5) (nonadherent NHs mean 3.7 ± 0.5 vs adherent NHs mean 4.3 ± 0.5), P = .048); and questionnaire response rate (nonadherent NHs 15.6 ± 10.0% vs adherent NHs 34.2 ± 12.1%, P = .02). Profit status, bed size, and number of NH deficiencies on state surveys were not significantly associated with intervention adherence.
CMS nurse staffing rating, leadership turnover, and questionnaire response rate are associated with adherence to a CRT intervention. Pretrial evaluation of NH staffing rating by CMS and of response to a questionnaire can help investigators improve trial efficiency by screening for NHs likely to adhere to a CRT intervention.