Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02543190
Study type Interventional
Source University of Minnesota - Clinical and Translational Science Institute
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date November 11, 2016

See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Recruiting NCT03560180 - Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: Italian ColoRectal Anastomotic Leakage Study Group.
Completed NCT03357497 - Very Early Mobilization of Colorectal Surgery Patients N/A
Recruiting NCT02143336 - Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients N/A
Completed NCT02846285 - Causes of Low Digestive Bleeding in Proctology N/A
Completed NCT01547572 - Psychological Preparation for Colorectal Surgery: Impact of Video Education N/A
Completed NCT00867958 - Compression Anastomosis Using the CARâ„¢ 27 N/A
Completed NCT00731978 - NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial N/A
Terminated NCT00413127 - Perioperative Protective Effects of Lidocaine Phase 2/Phase 3
Recruiting NCT00498290 - The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery N/A
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Not yet recruiting NCT03814681 - Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
Completed NCT03012802 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Completed NCT03620851 - Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)
Completed NCT03922113 - Muscle Function After Intensive Care
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT02999217 - Intravenous Iron for Correction of Anaemia After Colorectal Surgery Phase 4
Completed NCT01220661 - Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery Phase 2
Recruiting NCT00773981 - Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection Phase 3
Completed NCT03711487 - The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection Phase 2