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 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

• 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 theclinical 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

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 FacilitiesOverall Rating Stars US Nursing Facilities

(No./%)TURN US Facilities (No./%)

1 2362/15% 0/0%

2 3152/20% 4/20%

3 3201/20% 9/45%

4 4174/27% 5/25%

5 2663/17% 2/10%

Sum of 1 to 3 8715/56% 13/65%

Sum of 4 to 5 6837/44% 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