NCT03532256

Post-op Crowd Sourcing Health Data Via Text-messaging

Completed Results posted Last updated 4 June 2025

What this trial tests

trial testing Observation in Orthopedic Surgery in 127 participants. Completed in 16 September 2019.

Timeline

1 July 2019

Primary endpoint
16 September 2019

16 September 2019

Quick facts

Lead sponsor	University of Pennsylvania
Status	Completed
Study type	OBSERVATIONAL
Enrollment	127
Start date	1 July 2019
Primary completion	16 September 2019
Estimated completion	16 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Observation
• Text to online survey
• Bi-directional text script

Conditions studied

• Orthopedic Surgery — all drugs for Orthopedic Surgery →
• Opioid Use — all drugs for Opioid Use →
• Acute Injuries Knee — all drugs for Acute Injuries Knee →
• Neurosurgery — all drugs for Neurosurgery →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Orthopedic Surgery or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Opioid Tablets Taken Within 28 Days Primary · 28 days

We will tally number of pills taken within 28 days for each patient.

Group	Value	95% CI
Treated Patients Randomized to Receive Survey	8.05	± 6.02
Treated Patients Randomized to Receive Text Script	11.55	± 8.22

Number of Opioid Tablets Prescribed Per Procedure Encounter Secondary · 28 days

Tally of opioid tablets prescribed per procedure encounter before and after EMR defaults are implemented.

Group	Value	95% CI
Treated Patients	7.83	± 7.30
Treated Patients Randomized to Receive Survey	5.09	± 5.96
Treated Patients Randomized to Receive Text Script	11.03	± 7.50

Perceived Ability to Manage Pain Secondary · 28 days

Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)

Group	Value	95% CI
Treated Patients Randomized to Receive Survey	7.17	± 2.90
Treated Patients Randomized to Receive Text Script	6.69	± 2.63

Number of Opioid Pills Remaining Secondary · 28 days

Tally of opioid pills left after a patient reports discontinued use.

Group	Value	95% CI
Treated Patients Randomized to Receive Survey	15.62	± 9.10
Treated Patients Randomized to Receive Text Script	13.59	± 7.12

Response Rate Secondary · 28 days

Number of patients who respond to automated text with a survey or bi-directional text script

Group	Value	95% CI
Treated Patients Randomized to Receive Survey	1
Treated Patients Randomized to Receive Text Script	0

Completion Rate Secondary · 7 days

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

Group	Value	95% CI
Treated Patients Randomized to Receive Survey	18
Treated Patients Randomized to Receive Text Script	9

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Testing Digital Methods of Patient-Reported Outcomes Data Collection: Prospective Cluster Randomized Trial to Test SMS Text Messaging and Mobile Surveys.
   Agarwal AK, Ali ZS, Shofer F, Xiong R, et al · · 2022 · cited 6× · PMID 35298394 · DOI 10.2196/31894