Disorder of Hip RegionNCT02886741
A Ten-state Cluster-randomized Controlled Trial of the Institute for Health Improvement's Project JOINTS
A study testing Quality Improvement Campaign in people with Disorder of Hip Region, run by RAND.
Trial summary
In 2011, IHI designed a new campaign to accelerate uptake of evidence-based practices that had been shown to prevent surgical site infections (SSI) associated with hip and knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorder of Hip Region
- What is being tested?
- Quality Improvement Campaign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgeons, nurses, and other staff involved in direct care of patients undergoing hip or knee arthroplasty.
- Staff had to be affiliated with one of 20 hospitals selected at random from among all hospitals in each of 10 states that performed a minimum of 100 hip or knee arthroplasties for Medicare beneficiaries.
Who cannot join
- Per diem staff
About this study
Official title: Evaluation of a Multi-modal Network to Spread an Enhanced SSI Prevention Bundle
In 2011, IHI designed a new campaign to accelerate uptake of evidence-based practices that had been shown to prevent surgical site infections (SSI) associated with hip and knee arthroplasty. Project JOINTS (Joining Organizations IN Tackling SSIs was a multi-faceted, disciplined initiative that used the Rapid Spread Network (defined above), methods and tools developed during previous IHI campaigns to influence orthopedic practices and hospitals performing hip and knee arthroplasty. Rather than launch nationally as other campaigns have done, Project JOINTS was introduced in a cluster-randomized fashion to enable a rigorous, independent evaluation of its effectiveness in promoting uptake of new evidence-based practices.
Read the detailed description
For Project JOINTS, the evaluation team designed a state-level cluster randomized trial involving five pairs of states selected and matched on characteristics described below. One state from each pair received the 6-month Project JOINTS campaign, while the other state served as a control. To measure changes in the relevant evidence-based practices, RAND conducted a survey of orthopedic surgical staff in all ten states before and after Project JOINTS. The project was reviewed and approved by the RAND Institutional Review Board.
Intervention: Project JOINTS built on the notion of synergistic use of evidence-based practices.14 IHI designed and encouraged implementation of a five-component "enhanced" SSI prevention bundle included three relatively new evidence-based practices and two well-established Surgical Care Improvement Program (SCIP) practices. The three evidence-based practices not consistently implemented by hospitals prior to 2010 were:
- Screen patients for nasal Staphylococcus aureus (SA) carriage and decolonize SA carriers with five days of intranasal mupirocin and CHG bathing (minimum 3 consecutive days of daily use) in the days immediately preceding surgery;
- Instruct patients, regardless of SA carriage, to bathe or shower with chlorhexidine gluconate (CHG) for at least three days before surgery;
- Use an alcohol-containing antiseptic agent for preoperative skin preparation. The campaign recruited state organizations from the RSN developed during the 100,000 Lives and 5 Million Lives Campaigns. The state organizations reached out to hospitals in their states inviting them to participate in the campaign, disseminating information about the campaign and its evidence-based practices, and assisting IHI in publicizing activities described below and in a prior publication.
IHI developed a logic model summarizing how campaign activities were designed to achieve specified goals and this was discussed and refined in collaboration with the evaluation team in order to inform evaluation measures. IHI developed intervention materials (including a "How-to Guide," evidence reviews, a summary of the "business case" for the interventions to prevent SSIs, and tip sheets for surgeons and other providers, and patients and families), created and maintained a project website and email listserv, and offered a range of learning opportunities (including webinar calls, faculty-led office hours, and town hall meetings). Hospital and practice staff who participated in Project JOINTS (typically quality or safety improvement leaders and staff with oversight of infection prevention) received access to a password-protected IHI website maintained by IHI.
In addition to SSI prevention in hip and knee arthroplasty, the Project JOINTs "How To Guide" also addressed important elements of the "Model for Improvement," developed by Associates in Process Improvement and later adapted by IHI for use in its campaigns. These elements included: (1) the development of a QI plan (including explicit aims and a measurement framework); (2) small-scale tests of change- ("PDSA cycles") to refine implementation approaches through iterative learning; and (3) reliance on multi-disciplinary implementation teams. To enhance credibility with clinicians, IHI collaborated with relevant professional organizations, recruiting faculty from the American Academy of Orthopedic Surgeons (AAOS) and the American Association of Hip and Knee Surgeons (AAHKS) and obtaining endorsement from the AAHKS.
- Conditions
- Disorder of Hip Region
- Being tested
- Quality Improvement Campaign
- Keywords
- campaign, surgical site infection, orthopedic surgery, quality improvement, infection control
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement CampaignOther
"How To Guide" addressed development of a QI plan; small-scale tests of change- ("PDSA cycles") to refine implementation approaches through iterative learning; and reliance on multi-disciplinary implementation teams. IHI recruited relevant professional organizations to identify faculty.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Campaign | Other | IHI designed and encouraged implementation of a five-component "enhanced" surgical site infection (SSI) prevention bundle with three relatively new evidence-based practices and two Surgical Care Improvement Program (SCIP) practices.
The campaign recruited state organizations to share information about evidence-based practices and publicize IHI activities and intervention materials (a "How-to Guide," evidence reviews, a summary of the "business case" for interventions, and tip sheets for surgeons, other providers, patients and families). A project website and email listserv offered learning opportunities including webinar calls, faculty-led office hours, and town hall meetings. Receives: Other: Quality Improvement Campaign |
| Comparison | No intervention | Matched state pairs received no campaign intervention and experienced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to new evidence based practices
The questions addressed three actions (or subcomponents) constituting the nasal screening and decolonization process (new practice 1): screening for SA (1.a.); mupirocin nasal decolonization for methicillin-resistant SA (MRSA) (1.b.) and mupirocin nasal decolonization for methicillin-sensitive SA (MSSA) (1.c.). It included a question on skin decolonization using CHG (new practice 2) and a question on alcohol-containing antiseptic in the operating room (new practice 3). Respondents were asked to indicate the frequency of use of each practice among patients undergoing hip or knee arthroplasty. Response options ranged from 0 to 100% in 10% increments and a "don't know" option. The survey separated practices one and two, but these may not be effective if not used together.
Measured: 6 months
Secondary outcomes (1)
Adherence to established SCIP practices
The survey also included questions on evidence-based practices previously promoted by an established SSI prevention program (the Surgical Care Improvement Program or SCIP): a question about initiation of perioperative intravenous antibiotics within the appropriate time interval prior to the start of arthroplasty (4.a.), a question about use of intravenous vancomycin for prophylaxis for patients known to be MRSA carriers (4.b.), and a question on use of appropriate hair removal techniques
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Hip RegionStudies 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
- Masking
- None (open label)
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Healthcare Improvement
- Responsible party
- Sponsor
- Investigators
- Eric C Schneider, MD, Principal investigator, The Commonwealth Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886741
- Sponsor's protocol ID
- 2010-0488-CR05
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate data provided upon request
Publications
Khodyakov D, Ridgely MS, Huang C, DeBartolo KO, Sorbero ME, Schneider EC. Project JOINTS: what factors affect bundle adoption in a voluntary quality improvement campaign? BMJ Qual Saf. 2015 Jan;24(1):38-47. doi: 10.1136/bmjqs-2014-003169. Epub 2014 Nov 5.
PubMed 25376449
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multi-modal Network to Spread an Enhanced SSI Prevention Bundle
- ClinicalTrials.gov ID
- NCT02886741
- Acronym / sponsor ID
- 2010-0488-CR05
- Conditions
- Disorder of Hip Region
- Keywords
- campaign, surgical site infection, orthopedic surgery, quality improvement, infection control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Institute for Healthcare Improvement
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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.
In 2011, IHI designed a new campaign to accelerate uptake of evidence-based practices that had been shown to prevent surgical site infections (SSI) associated with hip and knee arthroplasty. Project JOINTS (Joining Organizations IN Tackling SSIs was a multi-faceted, disciplined initiative that used the Rapid Spread Network (defined above), methods and tools developed during previous IHI campaigns to influence orthopedic practices and hospitals performing hip and knee arthroplasty. Rather than launch nationally as other campaigns have done, Project JOINTS was introduced in a cluster-randomized fashion to enable a rigorous, independent evaluation of its effectiveness in promoting uptake of new evidence-based practices.
Detailed description
For Project JOINTS, the evaluation team designed a state-level cluster randomized trial involving five pairs of states selected and matched on characteristics described below. One state from each pair received the 6-month Project JOINTS campaign, while the other state served as a control. To measure changes in the relevant evidence-based practices, RAND conducted a survey of orthopedic surgical staff in all ten states before and after Project JOINTS. The project was reviewed and approved by the RAND Institutional Review Board.
Intervention: Project JOINTS built on the notion of synergistic use of evidence-based practices.14 IHI designed and encouraged implementation of a five-component "enhanced" SSI prevention bundle included three relatively new evidence-based practices and two well-established Surgical Care Improvement Program (SCIP) practices. The three evidence-based practices not consistently implemented by hospitals prior to 2010 were:
- Screen patients for nasal Staphylococcus aureus (SA) carriage and decolonize SA carriers with five days of intranasal mupirocin and CHG bathing (minimum 3 consecutive days of daily use) in the days immediately preceding surgery;
- Instruct patients, regardless of SA carriage, to bathe or shower with chlorhexidine gluconate (CHG) for at least three days before surgery;
- Use an alcohol-containing antiseptic agent for preoperative skin preparation. The campaign recruited state organizations from the RSN developed during the 100,000 Lives and 5 Million Lives Campaigns. The state organizations reached out to hospitals in their states inviting them to participate in the campaign, disseminating information about the campaign and its evidence-based practices, and assisting IHI in publicizing activities described below and in a prior publication.
IHI developed a logic model summarizing how campaign activities were designed to achieve specified goals and this was discussed and refined in collaboration with the evaluation team in order to inform evaluation measures. IHI developed intervention materials (including a "How-to Guide," evidence reviews, a summary of the "business case" for the interventions to prevent SSIs, and tip sheets for surgeons and other providers, and patients and families), created and maintained a project website and email listserv, and offered a range of learning opportunities (including webinar calls, faculty-led office hours, and town hall meetings). Hospital and practice staff who participated in Project JOINTS (typically quality or safety improvement leaders and staff with oversight of infection prevention) received access to a password-protected IHI website maintained by IHI.
In addition to SSI prevention in hip and knee arthroplasty, the Project JOINTs "How To Guide" also addressed important elements of the "Model for Improvement," developed by Associates in Process Improvement and later adapted by IHI for use in its campaigns. These elements included: (1) the development of a QI plan (including explicit aims and a measurement framework); (2) small-scale tests of change- ("PDSA cycles") to refine implementation approaches through iterative learning; and (3) reliance on multi-disciplinary implementation teams. To enhance credibility with clinicians, IHI collaborated with relevant professional organizations, recruiting faculty from the American Academy of Orthopedic Surgeons (AAOS) and the American Association of Hip and Knee Surgeons (AAHKS) and obtaining endorsement from the AAHKS.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Campaign | Other | Other: Quality Improvement CampaignIHI designed and encouraged implementation of a five-component "enhanced" surgical site infection (SSI) prevention bundle with three relatively new evidence-based practices and two Surgical Care Improvement Program (SCIP) practices. The campaign recruited state organizations to share information about evidence-based practices and publicize IHI activities and intervention materials (a "How-to Guide," evidence reviews, a summary of the "business case" for interventions, and tip sheets for surgeons, other providers, patients and families). A project website and email listserv offered learning opportunities including webinar calls, faculty-led office hours, and town hall meetings. |
| Comparison | No intervention | –Matched state pairs received no campaign intervention and experienced usual care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgeons, nurses, and other staff involved in direct care of patients undergoing hip or knee arthroplasty.
- Staff had to be affiliated with one of 20 hospitals selected at random from among all hospitals in each of 10 states that performed a minimum of 100 hip or knee arthroplasties for Medicare beneficiaries.
Key exclusion criteria (1 listed)
- Per diem staff
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 |
|---|---|---|
| Quality Improvement Campaign"How To Guide" addressed development of a QI plan; small-scale tests of change- ("PDSA cycles") to refine implementation approaches through iterative learning; and reliance on multi-disciplinary implementation teams. IHI recruited relevant professional organizations to identify faculty. | Other | Quality Improvement Campaign |
Primary outcome
Adherence to new evidence based practices
Time frame: 6 months
The questions addressed three actions (or subcomponents) constituting the nasal screening and decolonization process (new practice 1): screening for SA (1.a.); mupirocin nasal decolonization for methicillin-resistant SA (MRSA) (1.b.) and mupirocin nasal decolonization for methicillin-sensitive SA (MSSA) (1.c.). It included a question on skin decolonization using CHG (new practice 2) and a question on alcohol-containing antiseptic in the operating room (new practice 3). Respondents were asked to indicate the frequency of use of each practice among patients undergoing hip or knee arthroplasty. Response options ranged from 0 to 100% in 10% increments and a "don't know" option. The survey separated practices one and two, but these may not be effective if not used together.
1 secondary outcome
Adherence to established SCIP practices
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Results publication: PubMed 25376449Khodyakov D, Ridgely MS, Huang C, DeBartolo KO, Sorbero ME, Schneider EC. Project JOINTS: what factors affect bundle adoption in a voluntary quality improvement campaign? BMJ Qual Saf. 2015 Jan;24(1):38-47. doi: 10.1136/bmjqs-2014-003169. Epub 2014 Nov 5.
- Individual participant dataSharing planned: No. Aggregate data provided upon request
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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. This study is not recruiting at the moment.
Eric C Schneider, MD principal investigator
The Commonwealth Fund
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Campaign in people with Disorder of Hip Region, run by RAND.
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 1 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: finished, as of the sponsor's last update on 1 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to new evidence based practices (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886741, which also lists 1 linked publication.
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 1 Sep 2016.