Post-op Crowd Sourcing Health Data Via Text-messaging

NCT03532256 | Completed Results

• 2 other identifiers: 827461HHSF223201810209C
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Quality Improvement; Prescription Use; Patient Experience; SMS Messaging; Crowd Sourcing

Outcome Measures

Primary Outcomes (1)

• Number of Opioid Tablets Taken Within 28 Days

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

  28 days

Secondary Outcomes (3)

• Number of Opioid Tablets Prescribed Per Procedure Encounter

  28 days

• Perceived Ability to Manage Pain

  28 days

• Number of Opioid Pills Remaining

  28 days

Other Outcomes (2)

• Response Rate

  28 days

• Completion Rate

  7 days

Study Arms (3)

Treated Patients

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.

Behavioral: Observation

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.

Behavioral: Observation; Behavioral: Text to online survey

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.

Behavioral: Observation; Behavioral: Bi-directional text script

Interventions

Observation BEHAVIORAL

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

Treated Patients; Treated patients randomized to receive survey; Treated patients randomized to receive text script

Text to online survey BEHAVIORAL

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 survey

Bi-directional text script BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age ≥18) 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 who own a mobile phone and can receive SMS text messaging at the University of Pennsylvania or Penn Presbyterian Medical Center.

You may qualify if:

• 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

You may not qualify if:

• Under 18
• Does not own mobile phone
• Owns mobile phone but cannot reliably receive SMS text messages

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (12)

• Understanding the Epidemic | Drug Overdose | CDC Injury Center [Internet]. 2017 [cited 2017 Nov 2];Available from: https://www.cdc.gov/drugoverdose/epidemic/index.html

  BACKGROUND

• Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

  PMID: 28033313 BACKGROUND

• Compressed Mortality, 1999-2015 Request Form [Internet]. [cited 2017 Nov 2];Available from: https://wonder.cdc.gov/controller/datarequest/D132

  BACKGROUND

• Pletcher MJ, Kertesz SG, Kohn MA, Gonzales R. Trends in opioid prescribing by race/ethnicity for patients seeking care in US emergency departments. JAMA. 2008 Jan 2;299(1):70-8. doi: 10.1001/jama.2007.64.

  PMID: 18167408 BACKGROUND

• Levy B, Paulozzi L, Mack KA, Jones CM. Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012. Am J Prev Med. 2015 Sep;49(3):409-13. doi: 10.1016/j.amepre.2015.02.020. Epub 2015 Apr 18.

  PMID: 25896191 BACKGROUND

• Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJ, Fellows B, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm S 2nd, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Silverman SM, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician. 2012 Jul;15(3 Suppl):S67-116.

  PMID: 22786449 BACKGROUND

• Nicholson B. Responsible prescribing of opioids for the management of chronic pain. Drugs. 2003;63(1):17-32. doi: 10.2165/00003495-200363010-00002.

  PMID: 12487620 BACKGROUND

• Gordon AL, Connolly SL. Treating Pain in an Established Patient: Sifting Through the Guidelines. R I Med J (2013). 2017 Oct 2;100(10):41-44.

  PMID: 28968622 BACKGROUND

• Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.

  PMID: 26987082 BACKGROUND

• American Academy of Pain Medicine - State Legislative Updates [Internet]. [cited 2017 Nov 2];Available from: http://www.painmed.org/advocacy/state-updates/

  BACKGROUND

• Preventing Opioid Misuse: Legislative Trends and Predictions > National Conference of State Legislatures [Internet]. [cited 2017 Nov 2];Available from: http://www.ncsl.org/blog/2017/01/31/preventing-opioid-misuse-legislative-trends-and-predictions.aspx

  BACKGROUND

• Agarwal AK, Ali ZS, Shofer F, Xiong R, Hemmons J, Spencer E, Abdel-Rahman D, Sennett B, Delgado MK. Testing Digital Methods of Patient-Reported Outcomes Data Collection: Prospective Cluster Randomized Trial to Test SMS Text Messaging and Mobile Surveys. JMIR Form Res. 2022 Mar 17;6(3):e31894. doi: 10.2196/31894.

  PMID: 35298394 DERIVED

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Results Point of Contact

• Title: Mucio Delgado, MD, Principal Investigator
• Organization: University of Pennsylvania

mucio.delgado@pennmedicine.upenn.edu

215-746-8256

Study Officials

• M. Kit Delgado, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Zarina Ali, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Anish Agarwal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 22, 2018
• Study Start: July 1, 2019
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)