Anita Stern, Mary Pat Rapp, Nancy Bergstrom & Susan Horn

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Preparing sites for theclinical trial

10. 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)

11. Nursing Facility Team • Site Coordinator • Site Supervisor or Unit Manager • Recruiter • Assessor • Charge Nurses • Certified Nurses Aides • Data Collector

12. Site Orientation • Overview (as study progressed each role/person identified earlier) • Training for specific roles • Mock trial (Mock patients) • Mock data collection • Launch study

13. 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

14. 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

15. 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

16. 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 ?”

17. 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

18. Facilities

19. 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)

20. CMS* Ratings of US Nursing Facilities *Centers for Medicare and Medicaid Services

21. 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