NCT06302088

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Oct 2024Dec 2027

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 4, 2024

Last Update Submit

March 20, 2024

Conditions

Keywords

Patient fallspatient-assist injuriessafety climate

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Waitlist Control Arm

NO INTERVENTION

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

SAINTS program Intervention Arm

EXPERIMENTAL

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

Interventions

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.

SAINTS program Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employed at participating sites (critical-access hospitals in rural Oregon)
  • Patient-care workers (e.g. RNs, CNAs)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Kendall M Dunlop-Korsness, MPH

CONTACT

David A Hurtado, ScD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share