Postoperative ComplicationsNCT03813537
Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure
A study testing Phone Call in people with Postoperative Complications, run by Syed Husain at 1 site in United States.
Trial summary
This study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Phone Call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 481 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 15 Jul 2024
- 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
- Age greater than 18 years old
- Patients who underwent colorectal surgery at The Ohio State University Wexner Medical Center
Who cannot join
- Patients under 18 years old
- Patients with limited ability to communicate
- Patients who do not have a telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure: A Randomized Prospective Clinical Trial
This study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to identify areas of improvement for discharging and following patients within 30 days of colorectal surgery.
Read the detailed description
This study will be a prospective clinical trial, in which colorectal surgery patients will be randomly assigned to a control or experimental group. Patients will be consented and randomized prior to discharge.The control group will be discharged with standard of care follow-up instructions described by The Ohio State University Wexner Medical Center (OSUWMC), and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. The experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but will also receive a phone call 3-days post procedure. During this phone call, the patient will be asked questions using a study-specific questionnaire that is based on the most frequent indications for readmission after colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately. To determine if patients had visited an ED or been readmitted to a hospital within 30 days of colorectal surgery, both the standard of care and intervention groups will receive a phone call 30-days post-discharge. At this time we will also conduct the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to measure patient satisfaction.
- Conditions
- Postoperative Complications
- Being tested
- Phone Call
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone CallOther
The experimental group will receive a phone call 3-days post procedure and asked questions based on the most frequent indications for readmission after colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The control will be discharged with standard of care follow-up instructions and scheduled for a standard follow-up clinic visit within 2-3 weeks post-op. |
| Phone Call | Experimental | The experimental group will receive a phone call intervention 3 days post-op. During this phone call, the patient will be asked questions using a study questionnaire based on the most frequent indications for readmission post colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately. Receives: Other: Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Phone Call (assess readmission rates)
Assess readmission rates
Measured: 3 days
Secondary outcomes (1)
Post Discharge Survey (assess patient satisfaction)
Assess patient satisfaction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start19 Jun 2018
- Primary completion1 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Model description
- Patients will be randomized to two arms: 1. Intervention: post operative phone call with protocol driven follow up pathway. 2. Control: Current standard post operative follow up practice at our institution.
- Masking
- None (open label)
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Husain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Syed Husain, Ohio State University
- Investigators
- Syed Husain, MBBS, Principal investigator, OSU Wexner Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813537
- Sponsor's protocol ID
- 2018H0207
- Status last verified
- Jul 2024
- First submitted
- 24 May 2018
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure: A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03813537
- Acronym / sponsor ID
- 2018H0207
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Syed HusainUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 23 Jan 2019 (actual)
- 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.
This study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to identify areas of improvement for discharging and following patients within 30 days of colorectal surgery.
Detailed description
This study will be a prospective clinical trial, in which colorectal surgery patients will be randomly assigned to a control or experimental group. Patients will be consented and randomized prior to discharge.The control group will be discharged with standard of care follow-up instructions described by The Ohio State University Wexner Medical Center (OSUWMC), and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. The experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but will also receive a phone call 3-days post procedure. During this phone call, the patient will be asked questions using a study-specific questionnaire that is based on the most frequent indications for readmission after colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately. To determine if patients had visited an ED or been readmitted to a hospital within 30 days of colorectal surgery, both the standard of care and intervention groups will receive a phone call 30-days post-discharge. At this time we will also conduct the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to measure patient satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to two arms: 1. Intervention: post operative phone call with protocol driven follow up pathway. 2. Control: Current standard post operative follow up practice at our institution.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The control will be discharged with standard of care follow-up instructions and scheduled for a standard follow-up clinic visit within 2-3 weeks post-op. |
| Phone Call | Experimental | Other: Phone CallThe experimental group will receive a phone call intervention 3 days post-op. During this phone call, the patient will be asked questions using a study questionnaire based on the most frequent indications for readmission post colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 18 years old
- Patients who underwent colorectal surgery at The Ohio State University Wexner Medical Center
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Patients with limited ability to communicate
- Patients who do not have a telephone
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 |
|---|---|---|
| Phone CallThe experimental group will receive a phone call 3-days post procedure and asked questions based on the most frequent indications for readmission after colorectal surgery. | Other | Phone Call |
Primary outcome
Post-Operative Phone Call (assess readmission rates)
Time frame: 3 days
Assess readmission rates
1 secondary outcome
Post Discharge Survey (assess patient satisfaction)
Time frame: 30 days
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 17 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Syed Husain, MBBS principal investigator
OSU Wexner Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Call in people with Postoperative Complications, run by Syed Husain at 1 site 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 2 inclusion and 3 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Post-Operative Phone Call (assess readmission rates) (time frame: 3 days). 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 17 Jul 2024.