4.6 Article

Predicting Nursing Home Adherence to a Clinical Trial Intervention: Lessons for the Conduct of Cluster Randomized Trials

Journal

JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
Volume 59, Issue 12, Pages 2332-2336

Publisher

WILEY
DOI: 10.1111/j.1532-5415.2011.03697.x

Keywords

cluster randomized trials; methodology; adherence; run-in period; intervention trials

Funding

  1. National Institute on Aging [K08 AG021527]
  2. Agency for Healthcare Research and Quality [R01 HS016463]

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OBJECTIVES: To describe factors predictive of nursing home (NH) adherence to a clinical trial intervention. DESIGN: Post hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse-physician telephone communication in NHs. SETTING: NH. PARTICIPANTS: All eligible licensed nursing staff in all participating NHs. MEASUREMENTS: 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. RESULTS: 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. CONCLUSION: 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. J Am Geriatr Soc 59: 2332-2336, 2011.

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