Perioperative Care Clinical Trial
Official title:
Reducing Surgical Readmissions Through Mobile Technology: A Randomized Controlled Trial
Verified date | August 2022 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized trial will study the effect of a mobile app that facilitates patient engagement (patients undergoing complex abdominal surgery will track metrics of interest to the surgeon, submit reports on their symptoms/pain/physical function, and upload wound images) on readmission to the hospital. This trial will also assess whether the app can impact surgical complication severity, number of emergency department visits, and readmission costs. 300 participants will be enrolled and can expect to be on study for 6 months.
Status | Completed |
Enrollment | 300 |
Est. completion date | August 10, 2022 |
Est. primary completion date | February 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Provision of signed and dated informed consent form - Stated willingness to comply with all study procedures and availability for the duration of the study - English speaking - Able to pass a cognitive screening test - Patient or caregiver has access to a device capable of running the MobiMD app (tablet or smartphone). - Undergoing complex abdominal surgery in the departments of surgical oncology, colorectal surgery, or transplant surgery, (Complex abdominal surgery is interpreted as whipple procedure, hyperthermic intraperitoneal chemotherapy (HIPEC), gastrectomy, distal pancreatectomy, liver transplant, pancreas transplant, simultaneous kidney and pancreas transplant, low anterior resection, and all bowel resections requiring an ostomy). Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 30-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey | Participant satisfaction will be measured at 30 days using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey. The CAHPS Surgical Care (S-CAHPS) survey focuses on key areas of perioperative patient care, including preoperative, day of operation, and postoperative care. As study intervention focuses on postoperative care, participants will be supplied with the portion of the questionnaire related to postoperative care (questions 26-35). | 30 days postoperative | |
Other | 90-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey | Participant satisfaction will be measured at 90 days using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey. The CAHPS Surgical Care (S-CAHPS) survey focuses on key areas of perioperative patient care, including preoperative, day of operation, and postoperative care. As study intervention focuses on postoperative care, participants will be supplied with the portion of the questionnaire related to postoperative care (questions 26-35). | 90 days postoperative | |
Other | 180-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey | Participant satisfaction will be measured at 180 days using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey. The CAHPS Surgical Care (S-CAHPS) survey focuses on key areas of perioperative patient care, including preoperative, day of operation, and postoperative care. As study intervention focuses on postoperative care, participants will be supplied with the portion of the questionnaire related to postoperative care (questions 26-35). | 180 days postoperative | |
Other | 30-day physical function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form score | Patient-reported outcomes in physical function will be collected at 30-days post-operatively. The outcome measure will be assessed by the NIH PROMIS short forms, which can be administered through the MobiMD app. The PROMIS Short Forms will be used and are publicly available from healthmeasures.net.
The PROMIS short forms are self-report instruments used to measure aspects of quality of life. The functional performance tests assess physical abilities (strength, mobility) in ways that are relevant to daily living. The short form consists of questions which can be answered on a scale of 1-5, where 1-unable to do, 2-with much difficulty, 3-with some difficulty,4-with a little difficulty, 5- without any difficulty. A higher scores correlates to more physically active person. |
30 days postoperative | |
Other | 90-day physical function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form score | Patient-reported outcomes in physical function will be collected at 90-days post-operatively. The outcome measure will be assessed by the NIH PROMIS short forms, which can be administered through the MobiMD app. The PROMIS Short Forms will be used and are publicly available from healthmeasures.net.
The PROMIS short forms are self-report instruments used to measure aspects of quality of life. The functional performance tests assess physical abilities (strength, mobility) in ways that are relevant to daily living. The short form consists of questions which can be answered on a scale of 1-5, where 1-unable to do, 2-with much difficulty, 3-with some difficulty,4-with a little difficulty, 5- without any difficulty. A higher scores correlates to more physically active person. |
90 days postoperative | |
Other | 180-day physical function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form score | Patient-reported outcomes in physical function will be collected at 180-days post-operatively. The outcome measure will be assessed by the NIH PROMIS short forms, which can be administered through the MobiMD app. The PROMIS Short Forms will be used and are publicly available from healthmeasures.net.
The PROMIS short forms are self-report instruments used to measure aspects of quality of life. The functional performance tests assess physical abilities (strength, mobility) in ways that are relevant to daily living. The short form consists of questions which can be answered on a scale of 1-5, where 1-unable to do, 2-with much difficulty, 3-with some difficulty,4-with a little difficulty, 5- without any difficulty. A higher scores correlates to more physically active person. |
180 days postoperative | |
Other | 30-day pain intensity as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form pain intensity scale | Patient-reported outcomes in physical function will be collected at 30-days post-operatively. The outcome measure will be assessed by the NIH PROMIS short forms, which can be administered through the MobiMD app. The PROMIS Short Form v2.0 - Pain Intensity measure will be used and is publicly available from healthmeasures.net.
PROMIS pain intensity scale consists of 3 questions which can be answered on a scale of 1-5, where 1- had no pain, 2- mild pain, 3- moderate pain, 4- severe pain, 5- very severe pain. The cumulative score can range from 5-15, where higher scores correlates to more pain. |
30 days postoperative | |
Other | 90-day pain intensity as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form pain intensity scale | Patient-reported outcomes in physical function will be collected at 90-days post-operatively. The outcome measure will be assessed by the NIH PROMIS short forms, which can be administered through the MobiMD app. The PROMIS Short Form v2.0 - Pain Intensity measure will be used and is publicly available from healthmeasures.net.
PROMIS pain intensity scale consists of 3 questions which can be answered on a scale of 1-5, where 1- had no pain, 2- mild pain, 3- moderate pain, 4- severe pain, 5- very severe pain. The cumulative score can range from 5-15, where higher scores correlates to more pain. |
90 days postoperative | |
Other | 180-day pain intensity as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form pain intensity scale | Patient-reported outcomes in physical function will be collected at 180-days post-operatively. The outcome measure will be assessed by the NIH PROMIS short forms, which can be administered through the MobiMD app. The PROMIS Short Form v2.0 - Pain Intensity measure will be used and is publicly available from healthmeasures.net.
PROMIS pain intensity scale consists of 3 questions which can be answered on a scale of 1-5, where 1- had no pain, 2- mild pain, 3- moderate pain, 4- severe pain, 5- very severe pain. The cumulative score can range from 5-15, where higher scores correlates to more pain. |
180 days postoperative | |
Other | Total number of days spent in-hospital for the readmission event | Readmission length of stay will be measured as the total number of days spent in-hospital for the readmission event. This data will be obtained from chart review and will include date of readmission through date of discharge. | Up to 90 days | |
Primary | Proportion of participants readmitted within 30 days of surgery | The primary aim of the study is to determine if using MobiMD app changes the proportion of participants readmitted to the hospital within 30 days of surgery. Readmission will be counted as "1" event and no readmission will be counted as "0" event. In concordance with the standards of Centers for Medicare and Medicaid services, multiple readmissions for the same participant within a 30-day period will be measured as one event. | 30 days postoperative | |
Secondary | Proportion of participants readmitted within 90 days of surgery | Readmission will be counted as "1" event and no readmission will be counted as "0" event. In concordance with the standards of Centers for Medicare and Medicaid services, multiple readmissions for the same participant within a 90-day period will be measured as one event. | 90 days post-operative | |
Secondary | 30 day postoperative complication severity as measured by Clavien-Dindo Score | Complications and their associated severity as measured by the Clavien-Dindo score will be reported at 30 days postoperatively. The Clavien-Dindo score ranges from 1 to 5, with higher score indicating more severe complication. This score will be obtained and scored from chart review. | 30 days postoperative | |
Secondary | 90 day postoperative complication severity as measured by Clavien-Dindo Score | Complications and their associated severity as measured by the Clavien-Dindo score will be reported at 90 days postoperatively. The Clavien-Dindo score ranges from 1 to 5, with higher score indicating more severe complication. This score will be obtained and scored from chart review. | 90 days postoperative | |
Secondary | Total number of emergency department visits at 30 days postoperative | The total number of emergency department and urgent care visits will be reported at 30 days postoperatively. This data will be obtained from chart review. | 30 days postoperative | |
Secondary | Total number of emergency department visits at 90 days postoperative | The total number of emergency department and urgent care visits will be reported at 90 days postoperatively. This data will be obtained from chart review. | 90 days postoperative | |
Secondary | Total readmission cost | The total readmission hospital cost will be calculated using fiscal data harvested form Clarity (Epic). Clarity includes direct/indirect and fixed/variable hospital cost and reimbursement for professional fees. These variables can be accessed in very short timeframes (1 week). The two trial arms will be compared with respect to total healthcare-associated readmission costs. | Up to 90 days postoperative |
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