title: Successful clinical trial research in nursing homes: the Improving Decision-Making Study.
abstract: BACKGROUND
  One in four Americans, and 70% of people who have dementia, will spend their final days in nursing home care. Clinical research, particularly clinical trials, rarely includes this population due to unique challenges in research methods and ethics. Families of advanced dementia patients make choices about tube feeding and other feeding options with limited access to information or communication. The cluster randomized trial, Improving Decision Making about Feeding Options for Dementia Patients, tests a decision aid intervention to improve the quality of decision making for this choice.
  
  
  OBJECTIVE
  Our objectives are (1) to describe the methods used in this trial; (2) to describe challenges and strategies for effective nursing home and nursing home resident recruitment and retention; and (3) to describe research ethics approaches to minimize harms and maximize benefits for this population.
  
  
  METHODS
  The study is a cluster randomized trial of a decision aid to inform and support the choice between tube feeding and assisted oral feeding in advanced dementia. Study subjects are paired surrogate decision makers and residents with advanced dementia and feeding problems, enrolled from nursing homes in North Carolina.
  
  
  RESULTS
  This trial enrolled 256 paired surrogate decision makers and residents in 24 nursing home sites, and 99% completed participation through the 3-month study period. The research team had prior clinical and investigative experience in this setting, and used multiple strategies to recruit and retain nursing home sites, providers, surrogates, and the residents for whom they spoke. Informed consent and human subjects' protections were designed to address the vulnerability of this population.
  
  
  CONCLUSIONS
  Cluster randomization was necessary to avoid contamination between control and intervention subjects, but may introduce confounding by site and intracluster correlation effects in analyses.
  
  
  CONCLUSIONS
  Strategies that facilitate nursing home recruitment, participant recruitment and protection of human subjects for a vulnerable population may be used by future investigators to expand the research evidence base for nursing home and dementia care.
authors: Division of Geriatric Medicine and Palliative Care Program, University of North Carolina, Chapel Hill, NC 27599-7550, USA. lhanson@med.unc.edu
authors: Laura C
authors: LC
authors: Hanson
authors: Robin
authors: R
authors: Gilliam
authors: Tae Joon
authors: TJ
authors: Lee
mesh_terms: D000368:Aged; D035843:Biomedical Research / Q000379:methods* / Q000592:standards; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D016000:Cluster Analysis; D003657:Decision Making; D003661:Decision Support Techniques; D003704:Dementia / Q000150:complications; D004750:Enteral Nutrition; D005247:Feeding Behavior; D005260:Female; D006801:Humans; D008297:Male; D009657:North Carolina; D009735:Nursing Homes / Q000706:statistics & numerical data*; D018579:Patient Selection; D011594:Psychometrics; D014481:United States