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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. 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;
  2. Instruct patients, regardless of SA carriage, to bathe or shower with chlorhexidine gluconate (CHG) for at least three days before surgery;
  3. 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.

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 groups in NCT02886741
Study groupRoleWhat they receive
Quality Improvement CampaignOtherIHI 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
ComparisonNo interventionMatched 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.

  1. 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)
  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.

  1. First posted1 Sep 2016 (estimated)
  2. Study startFeb 2012
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

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)
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

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.

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