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 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 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 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 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 Provide basic good care Prompt and complete responses to communications via phone or 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 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 All data by specific task on one page per day Specific forms – CNA/PSW Repositioning Checklist – Supervisor Repositioning Checklist – Nurse Assessor Skin Assessment Form

Preparing sites for the clinical trial

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 Site Coordinator Site Supervisor or Unit Manager Recruiter Assessor Charge Nurses Certified Nurses Aides Data Collector

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 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 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 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

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 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

Facilities Participated 207 Recruited and Trained 238 Interest, Referred or Screened 49 US8 Toronto

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 Overall Rating StarsUS Nursing Facilities (No./%) TURN US Facilities (No./%) 12362/15%0/0% 23152/20%4/20% 33201/20%9/45% 44174/27%5/25% 52663/17%2/10% Sum of 1 to 38715/56%13/65% Sum of 4 to 56837/44%7/35% *Centers for Medicare and Medicaid Services

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