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Post-op Crowd Sourcing Health Data Via Text-messaging

Using Text-messaging to Engage Patients and Crowdsource Data: an Opioid Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03532256
Enrollment
127
Registered
2018-05-22
Start date
2019-07-01
Completion date
2019-09-16
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Injuries Knee, Neurosurgery, Opioid Use, Orthopedic Surgery, Surgery

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

BEHAVIORALObservation

Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.

BEHAVIORALText 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.

BEHAVIORALBi-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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of Opioid Tablets Taken Within 28 Days28 daysWe will tally number of pills taken within 28 days for each patient.

Secondary

MeasureTime frameDescription
Number of Opioid Tablets Prescribed Per Procedure Encounter28 daysTally of opioid tablets prescribed per procedure encounter before and after EMR defaults are implemented.
Perceived Ability to Manage Pain28 daysPatient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Number of Opioid Pills Remaining28 daysTally of opioid pills left after a patient reports discontinued use.

Other

MeasureTime frameDescription
Response Rate28 daysNumber of patients who respond to automated text with a survey or bi-directional text script
Completion Rate7 daysNumber 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

ArmCount
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
Total127

Baseline characteristics

CharacteristicTreated Patients Randomized to Receive SurveyTreated Patients Randomized to Receive Text ScriptTotal
Age, Continuous39.2 years
STANDARD_DEVIATION 13.7
37.8 years
STANDARD_DEVIATION 14.2
38.5 years
STANDARD_DEVIATION 13.9
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
28 Participants26 Participants54 Participants
Sex: Female, Male
Male
35 Participants38 Participants73 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 630 / 64
other
Total, other adverse events
0 / 630 / 64
serious
Total, serious adverse events
0 / 630 / 64

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Treated Patients Randomized to Receive SurveyNumber of Opioid Tablets Taken Within 28 Days8.05 number of pills takenStandard Deviation 6.02
Treated Patients Randomized to Receive Text ScriptNumber of Opioid Tablets Taken Within 28 Days11.55 number of pills takenStandard Deviation 8.22
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Treated Patients Randomized to Receive SurveyNumber of Opioid Pills Remaining15.62 quantity of pills remainingStandard Deviation 9.1
Treated Patients Randomized to Receive Text ScriptNumber of Opioid Pills Remaining13.59 quantity of pills remainingStandard Deviation 7.12
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Treated Patients Randomized to Receive SurveyNumber of Opioid Tablets Prescribed Per Procedure Encounter7.83 # opioid tablets prescribed / procedureStandard Deviation 7.3
Treated Patients Randomized to Receive Text ScriptNumber of Opioid Tablets Prescribed Per Procedure Encounter5.09 # opioid tablets prescribed / procedureStandard Deviation 5.96
Treated Patients Randomized to Receive Text ScriptNumber of Opioid Tablets Prescribed Per Procedure Encounter11.03 # opioid tablets prescribed / procedureStandard Deviation 7.5
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Treated Patients Randomized to Receive SurveyPerceived Ability to Manage Pain7.17 units on a scaleStandard Deviation 2.9
Treated Patients Randomized to Receive Text ScriptPerceived Ability to Manage Pain6.69 units on a scaleStandard Deviation 2.63
Other Pre-specified

Completion Rate

Number of patients who complete the automated text survey or bi-directional text script

Time frame: 7 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treated Patients Randomized to Receive SurveyCompletion Rate18 Participants
Treated Patients Randomized to Receive Text ScriptCompletion Rate9 Participants
Other Pre-specified

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treated Patients Randomized to Receive SurveyResponse Rate1 Participants
Treated Patients Randomized to Receive Text ScriptResponse Rate0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026