Surgery Clinical Trial
Official title:
Using Text-messaging to Engage Patients and Crowdsource Data: an Opioid Pilot Study
NCT number | NCT03532256 |
Other study ID # | 827461 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | November 5, 2023 |
Verified date | February 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | November 5, 2023 |
Est. primary completion date | May 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
American Academy of Pain Medicine - State Legislative Updates [Internet]. [cited 2017 Nov 2];Available from: http://www.painmed.org/advocacy/state-updates/
Compressed Mortality, 1999-2015 Request Form [Internet]. [cited 2017 Nov 2];Available from: https://wonder.cdc.gov/controller/datarequest/D132
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. Erratum In: MMWR Recomm Rep. 2016;65(11):295. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Nicholson B. Responsible prescribing of opioids for the management of chronic pain. Drugs. 2003;63(1):17-32. doi: 10.2165/00003495-200363010-00002. — View Citation
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. — View Citation
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
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. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Response rate | Number of patients who respond to automated text with a survey or bi-directional text script | 28 days | |
Other | Completion rate | Number of patients who complete the automated text survey or bi-directional text script | 7 days | |
Primary | Number of opioid tablets taken at 7 days | We will tally number of pills taken at 7 days for each patient. We enroll patients for 12 months. | 28 days | |
Secondary | Number of opioid tablets prescribed | Tally of opioid tablets prescribed per procedure before and after EMR defaults are implemented. | 7 days | |
Secondary | Perceived ability to manage pain | Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest) | 28 days | |
Secondary | Number of opioid pills remaining | Tally of opioid pills left after a patient reports discontinued use. | 28 days |
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