A Ten-state Cluster-randomized Controlled Trial of the Institute for Health Improvement's Project JOINTS

RanD

Status: Completed

Conditions: Disorder of Hip Region

Treatments: Other: Quality Improvement Campaign

Study type: Interventional

Funder types: Other

Identifiers

NCT02886741

2010-0488-CR05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 549 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Per diem staff

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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549 participants in 2 patient groups

Quality Improvement Campaign

Other group

Description:

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.

Treatment:

Other: Quality Improvement Campaign

Comparison

No Intervention group

Description:

Matched state pairs received no campaign intervention and experienced usual care