Acute Injuries Knee, Neurosurgery, Opioid Use, Orthopedic Surgery, Surgery
Conditions
Keywords
Quality Improvement, Prescription Use, Patient Experience, SMS Messaging, Crowd Sourcing
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.
Interventions
Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.
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.
Subset of surgical patients will receive an automated bi-directional text message script with questions that assess pain, functional status, and opioid consumption.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Opioid Tablets Taken Within 28 Days | 28 days | We will tally number of pills taken within 28 days for each patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Opioid Tablets Prescribed Per Procedure Encounter | 28 days | Tally of opioid tablets prescribed per procedure encounter 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 28 days | Number of patients who respond to automated text with a survey or bi-directional text script |
| Completion Rate | 7 days | Number of patients who complete the automated text survey or bi-directional text script |
Countries
United States
Participant flow
Recruitment details
The study was a prospective, block randomized trial of adults undergoing elective orthopedic procedures between Jul 1-Aug 12, 2019. Objective: determine if method of digital patient engagement would impact response and completion rates. Primary outcome: response rate and total completion of PRO questionnaires. 127 participants were block randomized into receiving a mobile survey delivered as a hyperlink or responding to the same questions through an automated bidirectional texting system.
Pre-assignment details
Patient were asked to consent via a simple SMS text message response of yes. Only consenting patients were randomized to one of the study groups.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Observation: Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.
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. | 63 |
| 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.
Observation: Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.
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. | 64 |
| Total | 127 |
Baseline characteristics
| Characteristic | Treated Patients Randomized to Receive Survey | Treated Patients Randomized to Receive Text Script | Total |
|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 13.7 | 37.8 years STANDARD_DEVIATION 14.2 | 38.5 years STANDARD_DEVIATION 13.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 26 Participants | 54 Participants |
| Sex: Female, Male Male | 35 Participants | 38 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 64 |
| other Total, other adverse events | 0 / 63 | 0 / 64 |
| serious Total, serious adverse events | 0 / 63 | 0 / 64 |
Outcome results
Number of Opioid Tablets Taken Within 28 Days
We will tally number of pills taken within 28 days for each patient.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Patients Randomized to Receive Survey | Number of Opioid Tablets Taken Within 28 Days | 8.05 number of pills taken | Standard Deviation 6.02 |
| Treated Patients Randomized to Receive Text Script | Number of Opioid Tablets Taken Within 28 Days | 11.55 number of pills taken | Standard Deviation 8.22 |
Number of Opioid Pills Remaining
Tally of opioid pills left after a patient reports discontinued use.
Time frame: 28 days
Population: Tally of opioid pills left after a patient reports discontinued use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Patients Randomized to Receive Survey | Number of Opioid Pills Remaining | 15.62 quantity of pills remaining | Standard Deviation 9.1 |
| Treated Patients Randomized to Receive Text Script | Number of Opioid Pills Remaining | 13.59 quantity of pills remaining | Standard Deviation 7.12 |
Number of Opioid Tablets Prescribed Per Procedure Encounter
Tally of opioid tablets prescribed per procedure encounter before and after EMR defaults are implemented.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Patients Randomized to Receive Survey | Number of Opioid Tablets Prescribed Per Procedure Encounter | 7.83 # opioid tablets prescribed / procedure | Standard Deviation 7.3 |
| Treated Patients Randomized to Receive Text Script | Number of Opioid Tablets Prescribed Per Procedure Encounter | 5.09 # opioid tablets prescribed / procedure | Standard Deviation 5.96 |
| Treated Patients Randomized to Receive Text Script | Number of Opioid Tablets Prescribed Per Procedure Encounter | 11.03 # opioid tablets prescribed / procedure | Standard Deviation 7.5 |
Perceived Ability to Manage Pain
Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Patients Randomized to Receive Survey | Perceived Ability to Manage Pain | 7.17 units on a scale | Standard Deviation 2.9 |
| Treated Patients Randomized to Receive Text Script | Perceived Ability to Manage Pain | 6.69 units on a scale | Standard Deviation 2.63 |
Completion Rate
Number of patients who complete the automated text survey or bi-directional text script
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated Patients Randomized to Receive Survey | Completion Rate | 18 Participants |
| Treated Patients Randomized to Receive Text Script | Completion Rate | 9 Participants |
Response Rate
Number of patients who respond to automated text with a survey or bi-directional text script
Time frame: 28 days
Population: Participant surveys/text scripts only continue to day 28 if participants stated they plan to continue taking pills. All but 1 participant discontinued taking pills by day 21. Therefore, only 1 day 28 survey was sent (the participant responded) and 0 day 28 text scripts were sent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated Patients Randomized to Receive Survey | Response Rate | 1 Participants |
| Treated Patients Randomized to Receive Text Script | Response Rate | 0 Participants |