Post-op Crowd Sourcing Health Data Via Text-messaging
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| ClinicalTrials.gov Identifier: NCT03532256 |
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Recruitment Status :
Enrolling by invitation
First Posted : May 22, 2018
Last Update Posted : September 28, 2020
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| Tracking Information | ||||||||||
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| First Submitted Date | April 16, 2018 | |||||||||
| First Posted Date | May 22, 2018 | |||||||||
| Last Update Posted Date | September 28, 2020 | |||||||||
| Actual Study Start Date | October 1, 2018 | |||||||||
| Estimated Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Number of opioid tablets taken at 7 days [ Time Frame: 28 days ] We will tally number of pills taken at 7 days for each patient. We enroll patients for 12 months.
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| Original Primary Outcome Measures |
Number of opioid tablets taken at 7 days [ Time Frame: 7 days ] We will tally number of pills taken at 7 days for each patient. We enroll patients for 12 months.
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Post-op Crowd Sourcing Health Data Via Text-messaging | |||||||||
| Official Title | Using Text-messaging to Engage Patients and Crowdsource Data: an Opioid Pilot Study | |||||||||
| Brief Summary | The Center for Disease Control has labeled the opioid prescription drug crisis an "epidemic" in the United States and recently this epidemic has been named a public health emergency. Various medical and surgical societies have begun to release general opioid prescribing guidelines for providers addressing acute pain, but these do not highlight the patient perspective or experience. Identifying an acceptable opioid dose and duration has remained a challenge and is a nuanced process. Though policy and provider driven changes may begin to augment practice, these avenues may miss a crucial perspective; the patient's. | |||||||||
| Detailed Description | This is a quality improvement project aimed at building upon prior telephone-based patient follow-up. The research team will be launching a text messaging interface to collect and describe patient pain, functional status, and opioid usage with patients undergoing elective surgical procedures within the departments of orthopaedics and sports medicine, as well as patients treated in neurosurgery, general surgery, and the ED who own a mobile phone and can receive SMS text messaging (as measured by pain scale, patient reported functional status, and proportion of opioids used). Additionally, this project aims to evaluate the current standard of care of prescribing opioids to patients among orthopedic surgeons and emergency medicine providers for acute pain. BACKGROUND The study team has shown the ability of gathering patient level data from telephone follow up to guide physician behavior. In recent work, providing orthopaedic surgeons with data on patients' unused prescribed opioids has changed practice - patients now reporting a change from twenty unused pills down to seven unused pills. Though effective, telephone follow up is laborious and time consuming. The researchers seek to test an alternative approach for a rapid, scalable means of engaging patients and gathering patient level data to help inform provider practice. Text messaging offers a unique opportunity to quickly capture, analyze, and understand the patient experience. The research team has demonstrated the successes of communicating with patients via text-messaging by guiding patients through pre- and postoperative recovery via the program "Engaged Recovery at Penn" (ERAP). This program has enrolled over 900 patients across surgical specialties with automated text-based reminders. The researchers will investigate the intersection of digital patient centered communication, acute pain, and consumption of prescribed opioids to ultimately help inform providers and health systems. METHODS The study team will contact adult patients (age ≥18) undergoing elective surgical procedures within the departments of orthopaedics, sports medicine, and neurosurgery, as well as patients undergoing procedures in general surgery and the ED who own a mobile phone and can receive SMS text messaging at the University of Pennsylvania or Penn Presbyterian Medical Center. The researchers will build upon previous work by Dr. Delgado in which patients were approached for follow up data collection via telephone communication and translate the telephone script into a functional and approachable text messaging script. The researchers will work to build an automated bi-directional text script hosted on a secure web portal. The research team will test the ability to engage patients in these departments, gather data, and measure satisfaction with the automated text-messaging system. Data collected through the online texting portal will be used to demonstrate the ability of bi-directional texting to enhance data collection and then the researchers will utilize this data to develop, implement, and evaluate the use of EMR defaults for opioid prescribing for specific surgical procedures or acute painful conditions. In addition, the study team will build and deploy an online survey containing the script questions in order to test an alternative to capturing patient data. Using block randomization, a subset of patients will receive either 1) a link to the online survey or 2) the bidirectional text messing script. Patient questions will not change but the method of data collection will test which approach yields a higher response rate. The study team will collect both response and completion rates and evaluate which data collection method is more effective for gathering data using an automated system. Insights gained from this comparison will be used to develop the automated text system and methodology. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Adult patients (age ≥18) undergoing elective surgical procedures within the departments of orthopedics, sports medicine, and neurosurgery, as well as patients undergoing procedures in general surgery and the ED who own a mobile phone and can receive SMS text messaging at the University of Pennsylvania or Penn Presbyterian Medical Center. | |||||||||
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Enrolling by invitation | |||||||||
| Estimated Enrollment |
200 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | April 30, 2022 | |||||||||
| Estimated Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number | NCT03532256 | |||||||||
| Other Study ID Numbers | 827461 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University of Pennsylvania | |||||||||
| Study Sponsor | University of Pennsylvania | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | University of Pennsylvania | |||||||||
| Verification Date | September 2020 | |||||||||