Post-op Crowd Sourcing Health Data Via Text-messaging

Completed

• Conditions: Opioid Use; Surgery; Orthopedic Surgery; Neurosurgery; Acute Injuries Knee
• Interventions: Behavioral: Observation; Behavioral: Bi-directional text script; Behavioral: Text to online survey

• Registration Number: NCT03532256
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-22
• Study Start: 2018-10-01
• Primary Completion: 2023-05-05
• Study Completion: 2023-11-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated patients randomized to receive text script	Observation	A subset of patients (described above) will receive an automated questionnaire conducted via text message. Questions will be about pain management and opioid use.
Treated patients randomized to receive text script	Bi-directional 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.
Treated Patients	Observation	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.
Treated patients randomized to receive survey	Observation	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.
Treated patients randomized to receive survey	Text to online 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.

Primary Outcome Measures

Name	Time	Method
Number of opioid tablets taken at 7 days	28 days	We will tally number of pills taken at 7 days for each patient. We enroll patients for 12 months.

Secondary Outcome Measures

Name	Time	Method
Number of opioid tablets prescribed	7 days	Tally of opioid tablets prescribed per procedure before and after EMR defaults are implemented.
Perceived ability to manage pain	28 days	Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Number of opioid pills remaining	28 days	Tally of opioid pills left after a patient reports discontinued use.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States