Accidental FallsSAINTSNCT06302088
The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals
A study testing SAINTS program in people with Accidental Falls and Injuries, run by Oregon Health and Science University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidental Falls, Injuries
- What is being tested?
- SAINTS program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employed at participating sites (critical-access hospitals in rural Oregon)
- Patient-care workers (e.g. RNs, CNAs)
Who cannot join
- Non-clinical staff (e.g. clerical, janitorial)
- Non-unit staff (e.g. physical therapy)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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).
- Conditions
- Accidental Falls, Injuries
- Being tested
- SAINTS program
- Keywords
- Patient falls, patient-assist injuries, safety climate
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAINTS programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SAINTS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12-month follow up surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Oct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hurtado, ScD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302088
- Sponsor's protocol ID
- STUDY00026205
- Acronym
- SAINTS
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Integration Stakeholders: A Randomized Control Trial to Minimize Patient Fall Risk and Reduce Patient-assist Injuries Among Critical Access Hospital Staff
- ClinicalTrials.gov ID
- NCT06302088
- Acronym / sponsor ID
- SAINTS / STUDY00026205
- Conditions
- Accidental Falls, Injuries
- Keywords
- Patient falls, patient-assist injuries, safety climate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: SAINTS programIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employed at participating sites (critical-access hospitals in rural Oregon)
- Patient-care workers (e.g. RNs, CNAs)
Key exclusion criteria (2 listed)
- Non-clinical staff (e.g. clerical, janitorial)
- Non-unit staff (e.g. physical therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAINTS programA 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. | Other | SAINTS program Intervention Arm |
Primary outcome
Safety participation
Time frame: Baseline and 12-month follow up surveys
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing SAINTS program in people with Accidental Falls and Injuries, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendall M Dunlop-Korsness, MPH (503-784-1588, dunlopko@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety participation (time frame: Baseline and 12-month follow up surveys). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.