Postpartum Opioid Prescribing Patterns and Patient Utilization

NCT03030742 | Completed DMC

• 1 other identifier: NortherwesternU
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to investigate the prescribing patterns and patient utilization of opioid pain medication in the postpartum setting. Postpartum women will be surveyed prior to hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid tablets they used (in relation to the number prescribed), pain satisfaction, and storage/disposal of any remaining opioid tablets.

Conditions

Postpartum; Opioid Use; Post-operative; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Postpartum outpatient opioid use

  Self reported number of opioid tablets used at time of postpartum survey administered 2-4 weeks postpartum

  8 weeks

Secondary Outcomes (3)

• Satisfaction with outpatient pain control

  8 weeks from time of hospital discharge

• Proper disposal/storage of remaining opioid tablets

  8 weeks from time of discharge

• High opioid use

  8 weeks from time of hospital discharge

Study Arms (2)

Post-cesarean delivery

Women who have undergone cesarean delivery

Other: Survey

Post-vaginal delivery

Women who have undergone vaginal delivery

Other: Survey

Interventions

Survey OTHER

A survey will be administered at two time points (time of hospital discharge and 2-4 weeks postpartum) to determine: * Satisfaction with pain control 2-4 weeks postpartum * Patient-reported use of opioid medication postpartum (receipt of prescription, filling of prescription, if refill was obtained, and number of opioid pills remaining at the time of follow-up) * Patient characteristics associated with high opioid use * Methods of storage and disposal of unused opioids

Also known as: Survey/Questionnaire

Post-cesarean delivery; Post-vaginal delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who are postpartum

You may qualify if:

• Women who deliver during the recruitment period
• English-speaking
• Opiate-naïve (as determined by admission medication reconciliation)
• Receive oral opioid medications during inpatient postpartum admission
• years or older

You may not qualify if:

• Contraindication to NSAID use
• Required use of general anesthesia without concurrent neuraxial analgesia
• Undergo hysterectomy, or unanticipated surgical procedures during the postpartum period
• Are admitted to the intensive care unit during their admission.

Sponsors & Collaborators

• Northwestern University: lead
• Society for Maternal-Fetal Medicine: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (14)

• Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women--United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013 Jul 5;62(26):537-42.

  PMID: 23820967 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.

  PMID: 22048730 BACKGROUND

• Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.

  PMID: 22786464 BACKGROUND

• Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/

  PMID: 23596641 BACKGROUND

• Peirce GL, Smith MJ, Abate MA, Halverson J. Doctor and pharmacy shopping for controlled substances. Med Care. 2012 Jun;50(6):494-500. doi: 10.1097/MLR.0b013e31824ebd81.

  PMID: 22410408 BACKGROUND

• Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.

  PMID: 21168869 BACKGROUND

• Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.

  PMID: 27631771 BACKGROUND

• Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.

  PMID: 26720857 BACKGROUND

• Paulozzi LJ, Mack KA, Hockenberry JM; Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines - United States, 2012. MMWR Morb Mortal Wkly Rep. 2014 Jul 4;63(26):563-8.

  PMID: 24990489 BACKGROUND

• Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.

  PMID: 25821010 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.

  PMID: 26996986 BACKGROUND

• Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.

  PMID: 27400458 BACKGROUND

• Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

  PMID: 26824844 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nevert Badreldin, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: June 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)