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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Injuries; Accidental Falls
• Intervention / Treatment: Other: SAINTS program

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).

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kendall M Dunlop-Korsness, MPH; Phone Number: 503-784-1588; Email: dunlopko@ohsu.edu
• Study Contact Backup: Name: David A Hurtado, ScD; Phone Number: 6175104114; Email: hurtadod@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control Arm; Control Arm engages in baseline, 6-and-12-month surveys, as well as baseline interviews and 24-month interviews. They engage in standard operating procedures and do not take part in the intervention
Experimental: SAINTS program Intervention Arm; Intervention arm engages in baseline, 6-and-12-month surveys, as well as baseline interviews and 24-month interviews. They engage in safety training programs and quality improvement cycles during the duration of the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: safety climate; Patient falls; patient-assist injuries
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: STUDY00026205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No