Colorectal SurgeryNCT00474097
Follow-Up Phone Calls After Colorectal Surgery
An observational study of Colorectal Surgery and Colorectal Neoplasms, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess if follow-up telephone calls after colorectal surgery affects a patient's satisfaction, the outcome of their surgery, and their quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Surgery, Colorectal Neoplasms, Colitis, Ulcerative
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2007
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal Surgery clinic patients
Who may be able to join
- Subjects who are 18 years of age and older
- Subjects of either sex
- Subjects who will undergo any moderate or major colorectal surgery requiring an overnight hospital stay at University Hospitals Case Medical Center
- Subjects who agree to participate in the study program and provide written informed consent
- Diagnoses such as Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and diverticulitis
Who cannot join
- Patients in the middle of three part surgery or had recent surgery (i.e., back for stoma closure for J-pouch)
- Patients with diagnosis of rectal prolapse, condyloma, and any conditions that require non-invasive outpatient procedures
- Pregnant women, minors, psychiatric patients and prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Follow-Up Phone Calls After Colorectal Surgery to Assess Patient Satisfaction and Post-Operative Outcomes
The purpose of this study is to assess if follow-up telephone calls after colorectal surgery affects a patient's satisfaction, the outcome of their surgery, and their quality of life. In addition, readmissions, complications and emergency room visits can be tracked via these telephone calls, ensuring optimal communication between patients and the surgical office.
Read the detailed description
Follow-up with patients after surgery is necessary to assess levels of rehabilitation, answer questions and expresses an attitude of caring, as well as assist in marketing procedures for the hospital or institution (Fallis, 2001). Surveillance after discharge from the hospital may be difficult as most patients are no longer monitored by health care professionals. If home health care is not required, the patient may not have contact with his/her doctor or nurse until the follow-up appointment which frequently is 4- 6 weeks post surgery.
There is evidence in the literature that telephone contact is beneficial for patients. The strongest and most current evidence came from a meta-analysis by Meade (2004) on research supporting phone calls post-operatively for hospitalized patients. This analysis provided a significant and valid review of health care professionals providing this service, looking at various patient populations and different hospital settings. 29 articles were published from 1981 to 2004 and reviewed to gather a compilation of research findings in this area. Regardless of the design of the research, the findings suggest that follow-up phone calls to patients after discharge provide invaluable opportunities to enhance practice in the following areas: Appraisal and evaluation of patient education, Practice improvement trends, Quality of care, Medication compliance and adherence to discharge instructions, Evaluation of overall hospital performance.
There is no evidence specifically addressing telephone contact after discharge in the colorectal surgery population which will be the basis of this study. Nurses providing follow-up phone calls to patients in the early post operative phase may assist in preventing or minimizing the effects of postoperative complications by reinforcing discharge instructions, answering patients' questions, and assessing their concerns. Potential serious complications may therefore be addressed early.
The purpose of this study is to assess if follow-up telephone calls after surgery affects patient satisfaction, surgical outcomes and quality of life in the early post-operative phase after colorectal surgery. In addition, tracking of readmissions, complications and emergency room visits via telephone calls can ensure communication between the patients and the surgical office is optimal.
- Conditions
- Colorectal Surgery, Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps
- Keywords
- Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps, Crohn Disease
- Medical subject headings
- Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess if follow-up telephone calls after surgery affects patient satisfaction, surgical outcomes and quality of life in the early post-operative phase after colorectal surgery
Measured: not specific
Secondary outcomes (1)
to track readmissions, complications and emergency room visits via telephone calls to ensure communication between the patients and the surgical office is optimal.
Measured: not specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startFeb 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor Delaney, MD, PhD, University Hospitals Cleveland Medical Center
- Investigators
- Conor Delaney, MD, PhD, Principal investigator, University Hospitals of Cleveland/ Institute for Surgical Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474097
- Sponsor's protocol ID
- 01-06-03
- Status last verified
- Dec 2014
- First submitted
- 15 May 2007
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up Phone Calls After Colorectal Surgery to Assess Patient Satisfaction and Post-Operative Outcomes
- ClinicalTrials.gov ID
- NCT00474097
- Acronym / sponsor ID
- 01-06-03
- Conditions
- Colorectal Surgery, Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps
- Keywords
- Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps, Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 May 2007 (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.
The purpose of this study is to assess if follow-up telephone calls after colorectal surgery affects a patient's satisfaction, the outcome of their surgery, and their quality of life. In addition, readmissions, complications and emergency room visits can be tracked via these telephone calls, ensuring optimal communication between patients and the surgical office.
Detailed description
Follow-up with patients after surgery is necessary to assess levels of rehabilitation, answer questions and expresses an attitude of caring, as well as assist in marketing procedures for the hospital or institution (Fallis, 2001). Surveillance after discharge from the hospital may be difficult as most patients are no longer monitored by health care professionals. If home health care is not required, the patient may not have contact with his/her doctor or nurse until the follow-up appointment which frequently is 4- 6 weeks post surgery.
There is evidence in the literature that telephone contact is beneficial for patients. The strongest and most current evidence came from a meta-analysis by Meade (2004) on research supporting phone calls post-operatively for hospitalized patients. This analysis provided a significant and valid review of health care professionals providing this service, looking at various patient populations and different hospital settings. 29 articles were published from 1981 to 2004 and reviewed to gather a compilation of research findings in this area. Regardless of the design of the research, the findings suggest that follow-up phone calls to patients after discharge provide invaluable opportunities to enhance practice in the following areas: Appraisal and evaluation of patient education, Practice improvement trends, Quality of care, Medication compliance and adherence to discharge instructions, Evaluation of overall hospital performance.
There is no evidence specifically addressing telephone contact after discharge in the colorectal surgery population which will be the basis of this study. Nurses providing follow-up phone calls to patients in the early post operative phase may assist in preventing or minimizing the effects of postoperative complications by reinforcing discharge instructions, answering patients' questions, and assessing their concerns. Potential serious complications may therefore be addressed early.
The purpose of this study is to assess if follow-up telephone calls after surgery affects patient satisfaction, surgical outcomes and quality of life in the early post-operative phase after colorectal surgery. In addition, tracking of readmissions, complications and emergency room visits via telephone calls can ensure communication between the patients and the surgical office is optimal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal Surgery clinic patients
Key inclusion criteria (5 listed)
- Subjects who are 18 years of age and older
- Subjects of either sex
- Subjects who will undergo any moderate or major colorectal surgery requiring an overnight hospital stay at University Hospitals Case Medical Center
- Subjects who agree to participate in the study program and provide written informed consent
- Diagnoses such as Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and diverticulitis
Key exclusion criteria (3 listed)
- Patients in the middle of three part surgery or had recent surgery (i.e., back for stoma closure for J-pouch)
- Patients with diagnosis of rectal prolapse, condyloma, and any conditions that require non-invasive outpatient procedures
- Pregnant women, minors, psychiatric patients and prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to assess if follow-up telephone calls after surgery affects patient satisfaction, surgical outcomes and quality of life in the early post-operative phase after colorectal surgery
Time frame: not specific
1 secondary outcome
to track readmissions, complications and emergency room visits via telephone calls to ensure communication between the patients and the surgical office is optimal.
Time frame: not specific
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 15 Dec 2014.
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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.
Conor Delaney, MD, PhD principal investigator
University Hospitals of Cleveland/ Institute for Surgical Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery and Colorectal Neoplasms, run by University Hospitals Cleveland Medical Center 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 5 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 15 Dec 2014. 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?
to assess if follow-up telephone calls after surgery affects patient satisfaction, surgical outcomes and quality of life in the early post-operative phase after colorectal surgery (time frame: not specific). 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 15 Dec 2014.