Trial Outcomes & Findings for Post-op Crowd Sourcing Health Data Via Text-messaging (NCT NCT03532256)
NCT ID: NCT03532256
Last Updated: 2025-06-04
Results Overview
We will tally number of pills taken within 28 days for each patient.
Recruitment status
COMPLETED
Target enrollment
127 participants
Primary outcome timeframe
28 days
Results posted on
2025-06-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
64
|
|
Overall Study
COMPLETED
|
63
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treated Patients Randomized to Receive Survey
n=63 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=64 Participants
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.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 13.7 • n=63 Participants
|
37.8 years
STANDARD_DEVIATION 14.2 • n=64 Participants
|
38.5 years
STANDARD_DEVIATION 13.9 • n=127 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=63 Participants
|
26 Participants
n=64 Participants
|
54 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=63 Participants
|
38 Participants
n=64 Participants
|
73 Participants
n=127 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 28 daysWe will tally number of pills taken within 28 days for each patient.
Outcome measures
| Measure |
Treated Patients Randomized to Receive Survey
n=63 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=64 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Opioid Tablets Taken Within 28 Days
|
8.05 number of pills taken
Standard Deviation 6.02
|
11.55 number of pills taken
Standard Deviation 8.22
|
—
|
SECONDARY outcome
Timeframe: 28 daysTally of opioid tablets prescribed per procedure encounter before and after EMR defaults are implemented.
Outcome measures
| Measure |
Treated Patients Randomized to Receive Survey
n=127 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=63 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=64 Participants
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.
|
|---|---|---|---|
|
Number of Opioid Tablets Prescribed Per Procedure Encounter
|
7.83 # opioid tablets prescribed / procedure
Standard Deviation 7.30
|
5.09 # opioid tablets prescribed / procedure
Standard Deviation 5.96
|
11.03 # opioid tablets prescribed / procedure
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: 28 daysPatient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Outcome measures
| Measure |
Treated Patients Randomized to Receive Survey
n=63 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=64 Participants
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.
|
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.
|
|---|---|---|---|
|
Perceived Ability to Manage Pain
|
7.17 units on a scale
Standard Deviation 2.90
|
6.69 units on a scale
Standard Deviation 2.63
|
—
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Tally of opioid pills left after a patient reports discontinued use.
Tally of opioid pills left after a patient reports discontinued use.
Outcome measures
| Measure |
Treated Patients Randomized to Receive Survey
n=63 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=64 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Opioid Pills Remaining
|
15.62 quantity of pills remaining
Standard Deviation 9.10
|
13.59 quantity of pills remaining
Standard Deviation 7.12
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
Number of patients who respond to automated text with a survey or bi-directional text script
Outcome measures
| Measure |
Treated Patients Randomized to Receive Survey
n=1 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Response Rate
|
1 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysNumber of patients who complete the automated text survey or bi-directional text script
Outcome measures
| Measure |
Treated Patients Randomized to Receive Survey
n=19 Participants
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.
|
Treated Patients Randomized to Receive Text Script
n=16 Participants
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.
|
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.
|
|---|---|---|---|
|
Completion Rate
|
18 Participants
|
9 Participants
|
—
|
Adverse Events
Treated Patients Randomized to Receive Survey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treated Patients Randomized to Receive Text Script
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mucio Delgado, MD, Principal Investigator
University of Pennsylvania
Phone: 215-746-8256
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place