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Completed

NCT Number: NCT02543190

System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program

Short-term post-operative complications after colon and rectal surgery present a known major clinical and financial burden for patients and hospitals. Focused efforts to reduce readmissions after colorectal surgery is one potentially high-yield and broad approach to address this problem since post- operative complications are the strongest predictor of readmissions. We focus on decreasing readmissions after ileostomy surgery by using a previously published intervention that prevents dehydration in the outpatient setting and decreases acute renal failure complications. We plan to introduce the SWIFT post op program for ileostomy patients at one academic and two community hospitals which are part of a single health care system, and to then randomize patients to usual care in the setting of this new program versus an aggressive compliance surveillance and improvement strategy (CSIS) strategy using study personnel. Our primary study outcome is all-cause 30-day readmission, and our secondary outcomes include patient satisfaction (CAHPS scores) and a cost-benefit analysis. We seek to create a partnership between colorectal surgeons, inpatient nurse managers and wound ostomy continence nurses (WOCN) at the three sites, linking them with outpatient nurse practitioners and physician's assistants at the respective colorectal surgery clinics who facilitate care-transition after hospital discharge.

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Key information

Conditions

Colectomy Colorectal Surgery Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Medical Center -Fairview, Minneapolis, Minnesota, United States

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About this study

At the start of the study, inpatient and outpatient nurses, physicians and physicians assistants will be oriented to the intervention in the study and will be suggested that the intervention is standard of care based on the following study:

Nagle D, Pare T, Keenen E, Marcet K, Tizio S, Poylin V*. Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ostomates. Diseases of the Colon and Rectum 2012; 55: 1266-1272.

The intervention patients will be subject to a compliance surveillance and intervention strategy (CSIS) administered by study personnel to encourage the following and persist with telephone calls if the following have not been achieved.

  • Prospective audits by study personnel to check and encourage teaching in the clinic, teaching on the wards, and telephone follow up occurred.
  • A self-assessment tool for patients and families to confirm understanding of the education materials.
  • Coaching of inpatient nurses taking care of ileostomy patients by WOCN and/or the inpatient nurse champion
  • Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to review the educational materials and administer a screening questionnaire to identify patients at risk of dehydration. In patients randomized to CSIS, study personnel will ensure this phone call is made.

The usual care arm will include no such surveillance.

The randomized study will be powered to detect a decrease in hospital readmission rates (all-cause) from 25% to 5%. Secondary outcomes include readmission due to dehydration and patient satisfaction (Surgical-CAHPS survey)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are scheduled or who undergo ileostomy alone or as part of a multiple procedure operation
  • patients who have had an ileostomy in the past are eligible
  • patients who have an ileostomy to address a recent surgical complication are eligible

Exclusion criteria

  • Patients who have an ileostomy already in place immediately prior to the procedure (ie. revision, transposition, or parastomal hernia procedures
  • patients on dialysis
  • patients who require chronic TPN, IVF, or have short gut
  • non-English speaking patients who do not have easy access to an appropriate interpreter.

Treatment and study plan

compliance surveillance and improvement strategy

Behavioral

External monitor to ensure compliance with an educational protocol.

Primary outcomes

  1. Readmission to the hospital

    Time frame: 30 days after hospital discharge

Secondary outcomes

  1. Patient satisfaction

    Time frame: 3-6 months after surgery

    S-CAHPS

  2. Index length-of-stay

    Time frame: Index length-of-stay

    Time from surgical date to hospital discharge

  3. Emergency room visit

    Time frame: 30 days after hospital discharge

    Emergency room visits for any reason 30 days after surgery

  4. Total hospital-length-of-stay

    Time frame: 30 days after hospital discharge

    Total hospital length of stay for any reason after surgery

  5. Readmission due to dehydration or acute renal failure

    Time frame: 30 days after hospital discharge

    Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria

  6. Post-discharge follow up phone call

    Time frame: 30 days after hospital discharge

    Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Colon and Rectal Surgery Associates, Ltd.

Registry information

Acronym: SWIFT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2015
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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