Clinical trial NCT02880176: Steps to Eliminate Postoperative Problems
Official title: Steps to Eliminate Postoperative Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Behavioral Economics
Financial Incentives
Bladder Cancer
Ambulation
Surgical Co-Morbidity
Fitbit
Mobile Health
Radical Cystectomy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-08-26
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.

Detailed description: In this application, a randomized controlled trial will be used to test the hypothesis that small financial incentives can be used to increase post-operative ambulation. The randomized controlled trial design is necessary to demonstrate a causal relationship between the intervention (provision of financial incentives)and the outcome (increased ambulation). This design will also provide preliminary data (e.g. effect sizes, feasibility) needed to design larger trials that will determine whether increases in ambulation produced by financial incentives can be translated into decreases in clinically relevant outcomes such as post-operative complications, readmissions, and functional decline in patients undergoing major abdominal surgery.

All participants will receive education about the importance of early ambulation and knowledge of their daily step goals. A Fitbit Zip, a commercially available activity tracking device with the ability to record and wirelessly upload step counts, will be provided to each participant to measure the outcome of daily step counts for a lead in period of 1-2 weeks before surgery and 30 days after surgery with the option for patients to continue to submit data independently for up to 90 days after surgery. The lead-in period will provide data to determine a patient-specific daily step count baseline. Step count goals will change each week and be determined by a set-percentage of the patient-specific baseline. The percentages will be as follows: 10% of baseline for week 1, 25% of baseline for week 2, 40% of baseline for week 3, and 55% of baseline for week 4. Data will be collected using the Way To Health platform, a digital platform specifically designed to facilitate randomized controlled trials testing interventions increase health promoting behavior.

Participants will be randomized using simple balanced randomization into one of two arms: "control" or "financial incentives". Individuals will be informed if they fail to achieve adequate steps and would have otherwise been eligible for payments in order to leverage regret aversion. The financial incentive is framed as a "gain" rather than a "loss" because striving to achieve a positive reward may provide the necessary support to positively motivate patients who just had major, painful surgery. Small definite payments are combined with larger lottery-based payments to provide ongoing feedback coupled with the possibility of winning a higher magnitude reward. Automated notification about payments will be delivered through the participant's preferred mode of communication (e.g., phone call, email). Patients will track their earnings and step count over time through Way to Health.

Beginning shortly before the planned surgery and continuing for 30 days after date of surgery, all participants will use Fitbit Zips to measure daily step counts. Patients will have the option of submitting up to 90 days of post-operative data. Post-operative ambulation has been repeatedly demonstrated to be beneficial to recovery by a number of different metrics, and the Zip device has been shown to be an accurate measure of step counts. The Stanford Health Assessment Questionnaire (SHAQ) is a broadly used and validated questionnaire which, in its shortened form, assesses subjects ability to perform 20 different actions and the need for assistance with these actions. It also captures patients global assessments of pain and well-being. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measured post-operative functional decline. The International Physical Activity Questionnaire (IPAQ) Short Seven Day form quantifies patient reported levels of physical activity over the seven days prior to the interview. It is similarly broadly used and has been previously validated against accelerometer data. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measure post-operative decline in physical activity and to discover differences in baseline physical activity that are not captured by preoperative step-count data.The Multidimensional Scale of Perceived Social Support (MPPSS) is a validated tool for assessing patient's self-assessed degree of support from others. Prior research has suggested social support as an important factor in exercise behavior, which is consistent with our clinical observations. This will be administered pre-operatively and a 30 and 90 days post-operatively to help account for confounding by this important and otherwise unmeasured variable.

Eligibility criteria: Inclusion Criteria:

* Planning to undergo radical cystectomy (either with ileal conduit, Indiana pouch, neobladder (e.g., Studer or Hautmann pouch) at the University of Pennsylvania
* Patient has been diagnosed with bladder cancer
* Patient is at least 21 years of age
* Patient is ambulatory with baseline ECOG performance status less than or equal to 2

Exclusion Criteria:

* Patient knows he or she will be unable or unwilling to use a mobile device and online tool to upload activity data
* Poor preoperative performance status (ECOG 3 or greater)
* Plan for cystectomy without cutaneous ureterostomies (without a bowel diversion)
* Non-English speakers
* Patient is non-ambulatory
* Patient is incapable of consenting himself or herself prior to surgery (Because participating in this trial involves ongoing effort on the part of the subject, patients who are incapable of consenting for themselves at baseline are excluded)
* Patients who do not have at least 24 hours of pre-operation ambulation data

Primary outcomes:
measure: Number of Days Step Goal Completed
timeFrame: 30 days
Secondary outcomes:
measure: Number of Steps Taken Per Day
timeFrame: 30 days
measure: Composite Morbidity Outcome of Complications, Unplanned Readmissions, or Emergency Department Visits
timeFrame: 30 days
measure: Functional Decline as Assessed by the Stanford Health Assessment Questionnaire (SHAQ)
timeFrame: 1 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Gregory Tasian, MD,MSc,MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Thomas Guzzo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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