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Facility identification, characteristics, and orientation to enable the conduct of a randomized trial in nursing facilities. Anita Stern, Mary Pat Rapp, Nancy Bergstrom & Susan Horn. Purpose.

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Facility identification, characteristics, and orientation to enable the conduct of a randomized trial in nursing facilities

Anita Stern, Mary Pat Rapp,

Nancy Bergstrom & Susan Horn

purpose
Purpose
  • Describe the process of identifying and screening nursing facilities for participation in a Phase 3 trial
  • Describe research/documentation tools
  • Identify the approach to prepare nursing facilities for participation in the trial
  • Discuss facility characteristics that predicted successful recruitment
planned settings in the us
Planned Settings in the US
  • Proposed 3 sites that were STARS in NNHIC*
  • Piloted 2 sites, 10 participants each
  • Projected 300 participants each over 3 ½ years
  • Reality….
    • Site 1—DON of 10 years quit; ADON not able
    • Site 2 – New, intense personalized care initiative
    • Site 3 – Personnel changes

*National Nursing Home Improvement Collaborative

setting identification in the us
Setting Identification in the US

Settings identified by:

  • Previous work with NNHIC (NB) or NPULS* (SH) and demonstrated good practice and documentation
  • QIO recommendations
  • Advancing Excellence Campaign
  • Nurse Executive Council Members

* National Pressure Ulcer Long-Term Care Study

setting identification in canada
Setting Identification in Canada
  • Identified by THETA
    • Toronto Health Economics and Technology Assessment (THETA) Collaborative
  • 5 sites identified by positive responses to a previous pressure ulcer phone survey administered to a random sample of long-term care homes
  • 3 sites identified to target racially diverse populations
setting selection
Setting Selection
  • Provide basic good care
  • Prompt and complete responses to communications via phone or e-mail
  • Willingness to provide staff time to participate
  • Screening for capacity to perform the study
  • Later, asked facility to do an initial screening of residents to verify number of eligible participants
preparing data collection tools
Preparing Data Collection Tools
  • Meet research needs for consistent data recording
  • Meet practice needs for practicality (data grouped by delivery patterns) and parsimony (make it simple and clear)
  • Convenience and simplicity lead to more complete data
document formats
Document Formats
  • All data by specific task on one page per day
  • Specific forms
    • CNA/PSW Repositioning Checklist
    • Supervisor Repositioning Checklist
    • Nurse Assessor Skin Assessment Form
settings prepared for participation initial and later
Settings Prepared for Participation(Initial and Later)
  • IRB or Federal Wide Assurance
  • IRB training for selected facility staff via Collaborative Institutional Training Initiative (CITI) training, later training done with project staff on site
  • Facility agrees to provide staff to fill project roles, later listed project staff by name in preparation for training
  • Use high density foam mattresses (or provided by Ontario Ministry of Health)
nursing facility team
Nursing Facility Team
  • Site Coordinator
  • Site Supervisor or Unit Manager
  • Recruiter
  • Assessor
  • Charge Nurses
  • Certified Nurses Aides
  • Data Collector
site orientation
Site Orientation
  • Overview (as study progressed each role/person identified earlier)
  • Training for specific roles
  • Mock trial (Mock patients)
  • Mock data collection
  • Launch study
cna psw repositioning expectations
CNA/PSW Repositioning Expectations
  • Turn participants on the assigned schedule
  • Continue all other pressure ulcer prevention care
  • Document care procedures
    • Turning
    • Skin observations
    • Continence care
    • Bathing
    • Meal intake
charge nurse expectations
Charge Nurse Expectations
  • Document using Supervisor Repositioning Checklist
  • Assist CNA/PSW in completing the Shift Documentation
  • Initiate treatment for Stage 1 or 2 pressure ulcer (Pre-approved protocol)
  • Report Adverse Events to Nurse Managers and/or Supervisors and UT Center on Aging
assessors
Assessors
  • Braden Scale
    • Trained using video, vignettes, observation
    • Prior to study to determine selection and risk
    • Weekly throughout study
  • Skin Assessment
    • Trained using video, observation
    • Prior to study to determine eligibility
    • Weekly throughout study
    • Quarterly interrater reliability
assessors1
Assessors
  • Masked to turning frequency
    • Documentation in a folder at participant bedside
    • No visible cues in room
    • Assessor is licensed nurse from one unit who goes to another just to assess skin or
    • Is designated to assess skin on all residents
    • Asked monthly, “Can you guess the turning schedule of any participants ?”
patient safety
Patient Safety
  • CNA/PSW observes skin at every turn and documents (normal, red, open, bruised)
  • Nurse assessor does weekly skin assessment
  • Red areas reported to nurse by CNA/PSW
  • Assessed, dressed, and reported
  • Adverse event reporting upon discovery
  • Data and Safety Monitoring Board
facility characteristics
Facility Characteristics
  • Location
    • 20 US
      • 7 rural
      • 7 suburban
      • 6 urban
    • 7 Greater Toronto area
  • Profit status
    • Profit = 16
    • Not for profit = 11
  • Size (62 to 556 licensed beds)
cms ratings of us nursing facilities
CMS* Ratings of US Nursing Facilities

*Centers for Medicare and Medicaid Services

conclusions
Conclusions
  • Canadian facilities were similar in overall CMS ratings to nursing facilities in the US
  • Status represented private and public funding
  • Training was the equalizer in ability to implement
  • On-site study recruiter facilitated recruitment in Canada
  • Ongoing quality information maintains interest and keeps goals
  • Checklists were pivotal to consistency and became part of context of care