Clinical trial NCT06302088: The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals
Official title: Safety Integration Stakeholders: A Randomized Control Trial to Minimize Patient Fall Risk and Reduce Patient-assist Injuries Among Critical Access Hospital Staff
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Accidental Falls
Injuries
Keywords: Patient falls
patient-assist injuries
safety climate
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participating clinics will take part in baseline surveys of unit staff (n=240-360) and safety stakeholders will be identified. Following surveys, hospitals will be randomized to the control arm (n=3) or the intervention arm (n=3). Both groups will engage in key informant interviews on safety culture (n=30-60). Control group hospitals will continue standard operating procedures. Intervention group hospitals will engage in social network analysis of surveys, have peer leaders identified, and engage in safety leadership training and quality improvement cycles. All hospitals regardless of arm will take part in 6-and-12-month surveys and 24-month interviews.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Safety participation
timeFrame: Baseline and 12-month follow up surveys
Secondary outcomes:
Other outcomes:
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