The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals

Accidental Falls Clinical Trial

— SAINTS  

Official title:

Safety Integration Stakeholders: A Randomized Control Trial to Minimize Patient Fall Risk and Reduce Patient-assist Injuries Among Critical Access Hospital Staff

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302088
• Other study ID #: STUDY00026205
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Oregon Health and Science University
• Contact: Kendall M Dunlop-Korsness, MPH
• Phone: 503-784-1588
• Email: dunlopko[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act).

Description:

SAINTs program will follow a semi-structured, block randomized control design along with a multi-method process evaluation to identify the extent to which the program was delivered as planned and if it led to the adoption of preventative measures. RCT measures will consist of pre/post survey data (at 6 months, 12 months and 24 months) hosted through REDCap and available via link. Additional secondary, de-identified data in aggregate (e.g. # of patient falls, # of worker compensation claims) will supplement survey data. Process evaluation will consist of implementation logs and interviews with key players (safety and quality officers, front-line peer leaders). The semi-structured design allows for customization among different rural healthcare sites that will have unique resources and needs, therefore requiring unique, tailored solutions. The combination of qualitative and quantitative. The SAINTS program will be implemented in four stages. 1) involvement of patient and worker safety stakeholders (e.g., Employee Health and Safety Officer, Quality Director, unit medical directors), 2) use of Social Network Analysis (SNA) to identify peer-recognized safety leaders; 3) training modules to stakeholders on safety leadership, and 4)in implementation of QI cycles to address barriers to safe patient handling and mobility (SPHM).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Employed at participating sites (critical-access hospitals in rural Oregon)

• Patient-care workers (e.g. RNs, CNAs)

Exclusion Criteria:

• Non-clinical staff (e.g. clerical, janitorial)

• Non-unit staff (e.g. physical therapy)

Related Conditions & MeSH terms

• Accidental Falls
• Injuries
• Wounds and Injuries

Intervention

Other:
• SAINTS program
A brief descriptive name used to refer to the intervention(s) studied in each arm of the clinical study. A non-proprietary name of the intervention must be used, if available. If a non-proprietary name is not available, a brief descriptive name or identifier must be used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety participation	Shared perceptions that worker safety is a priority at a hospital. We will use the safety compliance scale developed by Neal and Griffin. A six-item scale will be used to measure this self-reported construct, including three items for safety compliance (e.g., "I use the correct safety procedures for carrying out my job") and another three items for safety participation (e.g., "I voluntarily carry out activities that help to improve workplace safety"). Higher scores mean higher safety participation.	Baseline and 12-month follow up surveys