Postpartum Opioid Prescribing Patterns and Patient Utilization

• Sponsor: Northwestern University
• Collaborator: Society for Maternal-Fetal Medicine
• Information provided by (Responsible Party): Lynn M Yee, Northwestern University

Tracking Information

• First Submitted Date: January 23, 2017
• First Posted Date: January 25, 2017
• Last Update Posted Date: August 21, 2018
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2017)

Postpartum outpatient opioid use [ Time Frame: 8 weeks ]

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03030742 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 23, 2017)

• Satisfaction with outpatient pain control [ Time Frame: 8 weeks from time of hospital discharge ]
  Satisfaction with pain control at the time of postpartum survey administered 2-4 weeks postpartum
• Proper disposal/storage of remaining opioid tablets [ Time Frame: 8 weeks from time of discharge ]
  Proportion of patients who report proper disposal/storage of remaining opioid tablets at the time of postpartum survey administered 2-4 weeks postpartum
• High opioid use [ Time Frame: 8 weeks from time of hospital discharge ]
  Comparison of characteristics of women with >50% remaining versus <50% remaining of prescribed opioid tablets

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Postpartum Opioid Prescribing Patterns and Patient Utilization
• Official Title: Postpartum Opioid Prescribing Patterns and Patient Utilization
• 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.

Detailed Description

Opiate abuse is a national epidemic and has paralleled the increase in opioid prescriptions, with diversion of surplus medication playing a key contributing role. As the majority of reproductive age women in the U.S. will experience childbirth, understanding opioid prescription patterns and patient opioid utilization in the postpartum period is critical.

Postpartum women will be recruited during a 9-month period to take part in pre-hospital discharge and 2-4 week postpartum surveys to prospectively assess opioid medication use with regard to quantity of opioid tablets prescribed and quantity used, storage and disposal of unused opioids and satisfaction with pain control.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Women who are postpartum

Condition

• Postpartum
• Opioid Use
• Post-operative
• Cesarean Delivery

Intervention

Other: Survey

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

Other Name: Survey/Questionnaire

Study Groups/Cohorts

• Post-cesarean delivery
  Women who have undergone cesarean delivery
  Intervention: Other: Survey
• Post-vaginal delivery
  Women who have undergone vaginal delivery
  Intervention: Other: Survey

Publications *

• 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.
• 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.
• 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. Review.
• Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010: Statistical Brief #149. 2013 Feb. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/
• 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.
• 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.
• 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.
• 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.
• 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.
• Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;(3):CD010450. doi: 10.1002/14651858.CD010450.pub2. Review.
• 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. Erratum in: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
• 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-naïve 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.
• 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. Erratum in: JAMA Intern Med. 2016 Sep 1;176(9):1412.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 23, 2017): 700
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2019
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
• 18 years or older

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Nevert Badreldin, MD; 312.472.4648; nevert.badreldin@northwestern.edu

Contact: Lynn Yee, MD; 312.472.0119; lynn.yee@northwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03030742
• Other Study ID Numbers: NortherwesternU
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Lynn M Yee, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Society for Maternal-Fetal Medicine
• Investigators: Not Provided
• PRS Account: Northwestern University
• Verification Date: August 2018