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Post-op Crowd Sourcing Health Data Via Text-messaging

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ClinicalTrials.gov Identifier: NCT03532256
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2018
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
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
 (submitted: June 11, 2019)
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.
Original Primary Outcome Measures
 (submitted: May 18, 2018)
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.
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2019)
  • Number of opioid tablets prescribed [ Time Frame: 7 days ]
    Tally of opioid tablets prescribed per procedure before and after EMR defaults are implemented.
  • Perceived ability to manage pain [ Time Frame: 28 days ]
    Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)
  • Number of opioid pills remaining [ Time Frame: 28 days ]
    Tally of opioid pills left after a patient reports discontinued use.
Original Secondary Outcome Measures
 (submitted: May 18, 2018)
  • Number of opioid tablets prescribed and number remaining [ Time Frame: 7 days ]
  • Perceived ability to manage pain [ Time Frame: 7 days ]
    Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2019)
  • Response rate [ Time Frame: 28 days ]
    Number of patients who respond to automated text with a survey or bi-directional text script
  • Completion rate [ Time Frame: 7 days ]
    Number of patients who complete the automated text survey or bi-directional text script
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
Condition
  • Orthopedic Surgery
  • Opioid Use
  • Acute Injuries Knee
  • Neurosurgery
  • Surgery
Intervention
  • Behavioral: Observation
    Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.
  • Behavioral: Text to online survey
    Subset of surgical patients will receive an automated text message with a link to a secure online survey with questions that assess pain, functional status, and opioid consumption.
  • Behavioral: Bi-directional text script
    Subset of surgical patients will receive an automated bi-directional text message script with questions that assess pain, functional status, and opioid consumption.
Study Groups/Cohorts
  • Treated Patients
    This prospective, observational study includes adult patients (age ≥18) undergoing elective surgical procedures within the departments of orthopedics, sports medicine, and neurosurgery, as well as patients treated for an acute injury and prescribed an opioid from the ED who own a mobile phone and can receive SMS text messaging at the University of Pennsylvania or Penn Presbyterian Medical Center.
    Intervention: Behavioral: Observation
  • Treated patients randomized to receive survey
    A subset of patients (described above) will receive an automated SMS text message with a link to an online survey. This survey contains the script questions about pain management and opioid use.
    Interventions:
    • Behavioral: Observation
    • Behavioral: Text to online survey
  • Treated patients randomized to receive text script
    A subset of patients (described above) will receive an automated questionnaire conducted via text message. Questions will be about pain management and opioid use.
    Interventions:
    • Behavioral: Observation
    • Behavioral: Bi-directional text script
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 18, 2018)
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:

  • Adults 18 or older
  • 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 at University of Pennsylvania Hospital or Penn Presbyterian Medical Center
  • Own a mobile phone and can receive SMS text messaging

Exclusion Criteria

  • Under 18
  • Does not own mobile phone
  • Owns mobile phone but cannot reliably receive SMS text messages
Sex/Gender
Sexes Eligible for Study: All
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
Removed Location Countries  
 
Administrative Information
NCT Number NCT03532256
Other Study ID Numbers 827461
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD will not be shared.
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: M. Kit Delgado, MD, MS University of Pennsylvania
Principal Investigator: Zarina Ali, MD University of Pennsylvania
Principal Investigator: Anish Agarwal, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date September 2020