RCT of Counseling Intervention on Post-op Opiate Use

September 18, 2019 updated by: Julian N Robinson, Brigham and Women's Hospital

The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial

This study is a randomized controlled trial to investigate the effect of a simple counseling intervention on post-operative narcotic requirements, with the hypothesis that women receiving this intervention will use fewer narcotics for pain management following cesarean section.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All women undergoing scheduled cesarean section at Brigham and Women's Hospital who meet eligibility for the study will be approached in the pre-operative area on the Labor and Delivery floor prior to her scheduled cesarean section. For eligible patients interested in participation, consent will be obtained, and the participant will be randomized to receive either an intervention script containing counseling about post-op narcotic use, or the control script containing information regarding post-partum depression. This script will then be read to the participant in the pre-operative area prior to her scheduled cesarean section.

Two types of data will then be collected: inpatient data, and outpatient data. Regarding inpatient data, study investigators will collect information from the electronic medical record about the quantity of narcotics used in the hospital, pain scores while in the hospital, and demographic information. In terms of outpatient data, study investigators will contact participants at 2 weeks and 6 weeks post-partum with questions from the Edinburgh post-partum depression scale score and the WHOQOL-BREF scale score, along with questions regarding their narcotic use at home. Specifically, participants will be asked during the informed consent process whether they agree to 1) receive an email with a brief online survey at 2 weeks post-partum, and 2) receive a follow-up phone call within the week after the email survey was sent if survey responses are not received, 3) receive a second email with a brief online survey at 6 weeks post-partum, 4) receive a follow-up phone call within the week after the second email survey was sent if survey responses are not received. Surveys will be emailed to participants using the Partner's REDCap service that is located behind the Partner's firewall. Investigators will also mine information about each participant's narcotic use from the MassPAT prescription monitoring database.

The endpoint of the study will be enrollment of our desired sample size.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Delivery by scheduled cesarean section at Brigham and Women's Hospital

Exclusion Criteria:

  • Answer "yes" to the question: "Has any provider talked to you this pregnancy about medications for pain control after your c-section?"
  • History of opiate abuse
  • Use of chronic opiates, benzodiazepines or gabapentin
  • History of chronic pain
  • Cesarean hysterectomy
  • Vertical skin incision
  • Myomectomy at the time of cesarean section
  • Non English-speaking
  • Patient of the investigator performing the recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Narcotic counseling script
Study participants will be read a script regarding post-cesarean section narcotic use.
Behavioral: Narcotic counseling script
Script regarding post-cesarean section narcotic use
Sham Comparator: Post-partum depression counseling script
Study participants will be read a script of the same length, and much of the same wording as the experimental script. However, this script's content is focused on post-partum depression.
Behavioral: Post-partum depression counseling script
Study participants will be read a script of the same length, and much of the same wording as the experimental script. However, this script's content is focused on post-partum depression.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
quantity of narcotics used in-hospital
Time Frame: 4 days
4 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
quantity acetaminophen used in-hospital
Time Frame: 4 days
4 days
quantity ibuprofen used in-hospital
Time Frame: 4 days
4 days
quantity ketorolac used in-hospital
Time Frame: 4 days
4 days
pain scale in-hospital
Time Frame: 1 day, 4 days
1 day, 4 days
narcotic prescription filled after discharge
Time Frame: 2 weeks
2 weeks
quantity of narcotics taken after discharge
Time Frame: 2 weeks
2 weeks
Edinburgh post-partum depression score
Time Frame: 2 weeks and 6 weeks
2 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017P000792

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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