ColectomySWIFTNCT02543190
System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program
A study testing compliance surveillance and improvement strategy in people with Colectomy and Colorectal Surgery, run by University of Minnesota at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colectomy, Colorectal Surgery, Ileostomy
- What is being tested?
- compliance surveillance and improvement strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to 11 Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota Medical Center -Fairview
Minneapolis, Minnesota, 55455
Colon and Rectal Surgery Associates
Saint Paul, Minnesota, 55114
About this study
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.
Read the detailed 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)
- Conditions
- Colectomy, Colorectal Surgery, Ileostomy
- Being tested
- compliance surveillance and improvement strategy
- Keywords
- Care Transition, Readmission, Rehospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compliance surveillance and improvement strategyBehavioural
External monitor to ensure compliance with an educational protocol.
| Study group | Role | What they receive |
|---|---|---|
| compliance surveillance | Experimental | * Prospective audits by study personnel
* Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to administer a screening questionnaire to identify patients at risk of dehydration. Study personnel will ensure this phone call is made. Receives: Behavioral: compliance surveillance and improvement strategy |
| Usual Care | No intervention | educational session at the start of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission to the hospital
Measured: 30 days after hospital discharge
Secondary outcomes (6)
Patient satisfaction
S-CAHPS
Measured: 3-6 months after surgery
Index length-of-stay
Time from surgical date to hospital discharge
Measured: Index length-of-stay
Emergency room visit
Emergency room visits for any reason 30 days after surgery
Measured: 30 days after hospital discharge
Total hospital-length-of-stay
Total hospital length of stay for any reason after surgery
Measured: 30 days after hospital discharge
Readmission due to dehydration or acute renal failure
Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria
Measured: 30 days after hospital discharge
Post-discharge follow up phone call
Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Colon and Rectal Surgery Associates, Ltd.
- Responsible party
- Sponsor
- Investigators
- Mary R Kwaan, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543190
- Sponsor's protocol ID
- 1408M52923
- Acronym
- SWIFT
- Status last verified
- Dec 2017
- First submitted
- 3 Sep 2015
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program
- ClinicalTrials.gov ID
- NCT02543190
- Acronym / sponsor ID
- SWIFT / 1408M52923
- Conditions
- Colectomy, Colorectal Surgery, Ileostomy
- Keywords
- Care Transition, Readmission, Rehospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Colon and Rectal Surgery Associates, Ltd.
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 7 Sep 2015 (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.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compliance surveillance | Experimental | Behavioral: compliance surveillance and improvement strategy* Prospective audits by study personnel * Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to administer a screening questionnaire to identify patients at risk of dehydration. Study personnel will ensure this phone call is made. |
| Usual Care | No intervention | –educational session at the start of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| compliance surveillance and improvement strategyExternal monitor to ensure compliance with an educational protocol. | Behavioural | compliance surveillance |
Primary outcome
Readmission to the hospital
Time frame: 30 days after hospital discharge
6 secondary outcomes
Patient satisfaction
Time frame: 3-6 months after surgery
Index length-of-stay
Time frame: Index length-of-stay
Emergency room visit
Time frame: 30 days after hospital discharge
Total hospital-length-of-stay
Time frame: 30 days after hospital discharge
Readmission due to dehydration or acute renal failure
Time frame: 30 days after hospital discharge
Post-discharge follow up phone call
Time frame: 30 days after hospital discharge
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 29 Dec 2017.
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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.
Mary R Kwaan, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compliance surveillance and improvement strategy in people with Colectomy and Colorectal Surgery, run by University of Minnesota at 2 sites in United States.
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 3 inclusion and 4 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Readmission to the hospital (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2017.