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Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period (IMPACT)

Primary Purpose

Substance Use Disorders, Pregnancy Related, Contraception

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyPath Intervention
Usual care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Newly postpartum women will be

  • 18 years old+,
  • who meet DSM-V criteria for substance use disorder confirmed by diagnostic coding in the patient's medical record and/or urine toxicology screen (UDS) found in the medical record,
  • who have delivered at Magee-Womens Hospital and
  • speak English

Exclusion Criteria:

Women will be excluded due to

  • fetal or neonatal death
  • severe psychiatric condition in need of immediate treatment or legal action that could interfere with participation (e.g. incarceration) and
  • substance use behaviors that do not meet Diagnostic and Statistical Manual (DSM-V) criteria for a SUD (e.g. recreational marijuana use)

Sites / Locations

  • Magee Womens Hospital of UPMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MyPath Intervention

Standard of Care

Arm Description

At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.

At the first visit participants randomized to this arm receive standard of care contraceptive counseling.

Outcomes

Primary Outcome Measures

Continuous use of participants' selected postpartum contraceptive method
Continuous use of participants selected postpartum contraceptive method as measured by use of her method without any temporary stop of greater than 1-month.
Continuous contraceptive use and method switching
Continuous contraceptive and method switching as measured by use of any method without any temporary stop of greater than 1-month at the time. Reasons for stopping or switching methods will also be obtained.

Secondary Outcome Measures

Use of moderate or highly effective method
Use of moderate or highly effective method as measured by number of women in each arm who select a user-dependent method (i.e. pill, patch, ring, injection), Long-Acting Reversible Contraceptive (LARC) methods or postpartum tubal ligation.
Unintended pregnancy
Unintentional pregnancy as measured by number of women that have had a pregnancy, evaluation of timing preferences (e.g. too soon, right time, too late), feelings towards the pregnancy (i.e. rank happiness on a 0 to 10 scale) and if the pregnancy was unwanted using validated questions from the National Survey of Family Growth.
Interpregnancy interval
Time-to-next pregnancy as measured by time-to-event analyses.
Contraceptive method selected
Women selecting a user-dependent method, Long-Acting Reversible Contraceptive (LARC) method or postpartum tubal ligation
Values concordance
We will measure women's perceptions of the values concordance of their selected postpartum contraceptive method as measured by a two-item adapted Measure of the Alignment of Choices (MATCH)
Knowledge
Reproductive planning knowledge as measured by an 18-item reproductive planning knowledge scale adapted from validated contraceptive knowledge assessments.
Involvement
Involvement in decision making as measured by the Interpersonal Quality in Family Planning care (IQFP).

Full Information

First Posted
June 23, 2021
Last Updated
May 16, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04939012
Brief Title
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
Acronym
IMPACT
Official Title
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs.
Detailed Description
The reproductive health needs of women with substance use disorders (SUDs) are unmet. Over 80% of pregnancies among women with SUDs are unintended, compared to 45% of the general population, and over 20% of women with SUDs have had a short interpregnancy interval (i.e. ≤ 18 months after a previous birth). Adverse reproductive health outcomes are perpetuated by contraceptive decisions that are inconsistent with women's reproductive goals. In an evaluation of women in opioid use disorder (OUD) treatment, only half of sexually active women not wanting to get pregnant used contraception, with condoms the most frequent method used. Pregnancy is a unique opportunity to address contraceptive needs due to increased healthcare access and expanded Medicaid eligibility, increased access to highly effective methods such as long-acting reversible contraception (LARC) and enhanced motivation to avoid rapid, repeat pregnancy. Despite this, over 75% of women with OUD do not use postpartum contraception and less than 2% receive LARC. Currently, there are no effective strategies to improve postpartum contraceptive decision-making for women with SUDs. As an initial step to address this gap, the investigators conducted an observational study of postpartum contraceptive choices among 194 women with OUD at our maternity hospital (Plan NOW). Per usual care, women were provided with information about all contraceptive options, consistent with "information-based" counseling, and access to all methods including immediate postpartum LARC. Several findings informed this proposal. First, women's postpartum contraceptive decisions were often inconsistent with their childbearing goals. Among women who did not want another child, 36% did not choose a highly effective method and 10% had a repeat pregnancy within one year. Second, women had limited contraceptive knowledge and frequent misconceptions about their fertility and vulnerability to pregnancy. Third, women's decisional autonomy regarding sex and contraception was often threatened due to ongoing illicit drug use and reproductive coercion by partners. Fourth, women who wanted another baby did not feel supported and often felt pressured to choose a highly effective method. Therefore, failure to frame contraceptive decisions within the larger reproductive health context of women with OUD was a major barrier to high quality decision-making. The goal of this research is to help women with SUDs make informed decisions about their reproductive health that align with their preferences, values and reproductive goals. Our objective in this application is to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs. Designed to facilitate high-quality decisions regarding pregnancy and contraception, MyPath helps women a) review their thoughts about pregnancy and children, b) learn about fertility and preconception health and c) prioritize their preferences for various contraceptive method characteristics (e.g. effectiveness, side effects). As such, MyPath uses a patient-centered approach to help women frame their contraceptive decisions in the context of their goals and health and is a critical first step towards addressing reproductive health inequities among women with SUDs. Our overarching hypothesis is that patient-centered, reproductive planning decision support will facilitate high quality decision-making and thus improve postpartum contraceptive utilization and reproductive health outcomes among women with SUDs. To test this hypothesis, the investigators propose a hybrid type 1 effectiveness-implementation randomized controlled trial, guided by the following aims: Aim 1: Assess the effect of patient-centered, reproductive planning decision support (MyPath) on postpartum contraceptive utilization and reproductive health outcomes among women with SUDs Aim 2: Determine if the relationship between MyPath and contraceptive utilization is mediated by decision quality. Decision quality will be measured using four patient-centered components of decision-making: knowledge, values concordance, decisional conflict and involvement. The investigators hypothesize that improvements in decision quality will mediate the relationship between MyPath and contraceptive utilization. Aim 3: Identify barriers and facilitators to integrating MyPath into routine postpartum clinical care. The investigators will gather process evaluation data during the randomized controlled trial (RCT) and conduct qualitative interviews with key patient, provider and health system stakeholders to identify potential barriers and facilitators to future implementation in maternity settings and routine postpartum clinical care, if MyPath is found to be effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Pregnancy Related, Contraception

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyPath Intervention
Arm Type
Experimental
Arm Description
At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
At the first visit participants randomized to this arm receive standard of care contraceptive counseling.
Intervention Type
Behavioral
Intervention Name(s)
MyPath Intervention
Intervention Description
MyPath is a novel patient-centered, reproductive planning decision support tool developed by the research team used to facilitate postpartum contraceptive decision-making among women with SUDs. Designed to facilitate high-quality decisions regarding pregnancy and contraception, MyPath helps women a) review their thoughts about pregnancy and children, b) learn about fertility and preconception health and c) prioritize their preferences for various contraceptive method characteristics (e.g. effectiveness, side effects). As such, MyPath uses a patient-centered approach to help women frame their contraceptive decisions in the context of their goals and health and is a critical first step towards addressing reproductive health inequities among women with SUDs.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Continuous use of participants' selected postpartum contraceptive method
Description
Continuous use of participants selected postpartum contraceptive method as measured by use of her method without any temporary stop of greater than 1-month.
Time Frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Title
Continuous contraceptive use and method switching
Description
Continuous contraceptive and method switching as measured by use of any method without any temporary stop of greater than 1-month at the time. Reasons for stopping or switching methods will also be obtained.
Time Frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Secondary Outcome Measure Information:
Title
Use of moderate or highly effective method
Description
Use of moderate or highly effective method as measured by number of women in each arm who select a user-dependent method (i.e. pill, patch, ring, injection), Long-Acting Reversible Contraceptive (LARC) methods or postpartum tubal ligation.
Time Frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Title
Unintended pregnancy
Description
Unintentional pregnancy as measured by number of women that have had a pregnancy, evaluation of timing preferences (e.g. too soon, right time, too late), feelings towards the pregnancy (i.e. rank happiness on a 0 to 10 scale) and if the pregnancy was unwanted using validated questions from the National Survey of Family Growth.
Time Frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Title
Interpregnancy interval
Description
Time-to-next pregnancy as measured by time-to-event analyses.
Time Frame
Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery
Title
Contraceptive method selected
Description
Women selecting a user-dependent method, Long-Acting Reversible Contraceptive (LARC) method or postpartum tubal ligation
Time Frame
Delivery, Immediate Post-delivery Inpatient Visit
Title
Values concordance
Description
We will measure women's perceptions of the values concordance of their selected postpartum contraceptive method as measured by a two-item adapted Measure of the Alignment of Choices (MATCH)
Time Frame
Enrollment (24 - 37 weeks pregnant) to 18 months post delivery
Title
Knowledge
Description
Reproductive planning knowledge as measured by an 18-item reproductive planning knowledge scale adapted from validated contraceptive knowledge assessments.
Time Frame
Enrollment (24 - 37 weeks pregnant) to 18 months post delivery
Title
Involvement
Description
Involvement in decision making as measured by the Interpersonal Quality in Family Planning care (IQFP).
Time Frame
Enrollment (24 - 37 weeks pregnant) to 18 months post delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly postpartum women will be 18 years old+, who meet DSM-V criteria for substance use disorder confirmed by diagnostic coding in the patient's medical record and/or urine toxicology screen (UDS) found in the medical record, who have delivered at Magee-Womens Hospital and speak English Exclusion Criteria: Women will be excluded due to fetal or neonatal death severe psychiatric condition in need of immediate treatment or legal action that could interfere with participation (e.g. incarceration) and substance use behaviors that do not meet Diagnostic and Statistical Manual (DSM-V) criteria for a SUD (e.g. recreational marijuana use)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Krans, MD
Phone
(412) 641-3532
Email
kransee@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Mayo, BA
Phone
(412) 641-2248
Email
mayos@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Krans, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayo Samantha, BA
Phone
412-641-2248
Email
mayos@upmc.edu
First Name & Middle Initial & Last Name & Degree
Leah Klocke
Phone
(412) 641-6377
Email
klockelc@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to share data acquired through this study, however the research team may share de-identified data in the future.

Learn more about this trial

Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period

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