title: A randomized trial of heart failure disease management in skilled nursing facilities (SNF Connect): Lessons learned.
abstract: OBJECTIVE
  Conducting clinical trials in skilled nursing facilities is particularly challenging. This manuscript describes facility and patient recruitment challenges and solutions for clinical research in skilled nursing facilities.
  
  
  METHODS
  Lessons learned from the SNF Connect Trial, a randomized trial of a heart failure disease management versus usual care for patients with heart failure receiving post-acute care in skilled nursing facilities, are discussed. Description of the trial design and barriers to facility and patient recruitment along with regulatory issues are presented.
  
  
  RESULTS
  The recruitment of Denver-metro skilled nursing facilities was facilitated by key stakeholders of the skilled nursing facilities community. However, there were still a number of barriers to facility recruitment including leadership turnover, varying policies regarding research, fear of litigation and of an increased workload. Engagement of facilities was facilitated by their strong interest in reducing hospital readmissions, marketing potential to hospitals, and heart failure management education for their staff. Recruitment of patients proved difficult and there were few facilitators. Identified patient recruitment challenges included patients being unaware of their heart failure diagnosis, patients overwhelmed with their illness and care, and frequently there was no available proxy for cognitively impaired patients. Flexibility in changing the recruitment approach and targeting skilled nursing facilities with higher rates of admissions helped to overcome some barriers.
  
  
  CONCLUSIONS
  Recruitment of skilled nursing facilities and patients in skilled nursing facilities for clinical trials is challenging. Strategies to attract both facilities and patients are warranted. These include aligning study goals with facility incentives and flexible recruitment protocols to work with patients in "transition crisis."
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Daddato
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Heidi L
authors.initials: HL
authors.lastname: Wald
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Horney
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Diane L
authors.initials: DL
authors.lastname: Fairclough
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Erin C
authors.initials: EC
authors.lastname: Leister
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Marilyn
authors.initials: M
authors.lastname: Coors
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Warren H
authors.initials: WH
authors.lastname: Capell
authors.affiliation: GRECC Denver VA Eastern Colorado Health System and Division of Geriatric Medicine, Department of Internal Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Boxer
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000379:methods*; D006333:Heart Failure / Q000451:nursing*; D006760:Hospitalization; D006801:Humans; D018579:Patient Selection; D010360:Patient Transfer / Q000379:methods; D058996:Quality Improvement; D012107:Research Design; D012866:Skilled Nursing Facilities / Q000458:organization & administration*
keywords: Heart failure; clinical trial; skilled nursing facility