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One Key Question: Pilot Study at NorthShore

NCT ID: NCT03947788

Last Updated: 2021-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2021-01-06

Brief Summary

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This study is a pilot assessment of whether practices that implement the One Key Question® (OKQ) pregnancy intention screening tool will demonstrate differences in patient-reported receipt of preconception and/or contraceptive counseling, compared to practices that provide usual care. In Phase I, the study team surveyed patients at six practices within NorthShore University HealthSystem to establish baseline rates of counseling. Phase II assesses the effects of the OKQ tool on patient care, and half of participating sites are randomly chosen as intervention sites and exposed to the OKQ tool. After the intervention practices implement OKQ, patients will be surveyed at both intervention and control (usual care) practices to measure changes in preconception and contraceptive care.

Detailed Description

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Effectively delivered preconception counseling leads to healthier pregnancy behaviors. However, many clinicians miss opportunities to provide this counseling due to a lack of processes in place to provide this counseling and access to evidence based care once the need is identified. The purpose of this study is to build upon baseline data collected on pregnancy intention and receipt of contraceptive and preconception counseling. Half of the study practices will be randomly selected to receive comprehensive One Key Question® Training through the nonprofit Power To Decide. These practices have already displayed interest in taking part in this intervention.The training will act as our intervention, and will be given to help improve the quality of preconception and contraceptive counseling in Primary Care and Obstetrics/Gynecology. All of the participating practices will then be surveyed again to determine changes in contraception and preconception counseling. After patient data collection is complete, a research assistant will return to each practice to collect surveys from clinicians and staff (this includes: physicians, nurses, medical assistants, patient support associates, or anyone that participated in the OKQ training) at the intervention practices to assess the experience of implementing OKQ and their perceptions of its utility for patients. Following the Phase II collection of surveys, the remaining control practices will be given the option to receive Power To Decide training.

Conditions

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Reproductive Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Interventional Practices

These clinics, including physicians, clinical and administrative staff, will receive the One Key Question training program, delivered by Power to Decide, via an in-person group training session.

Group Type EXPERIMENTAL

OKQ Training Program

Intervention Type BEHAVIORAL

The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.

Control Practices

These clinics will not receive the OKQ training program during the study period. They will have the opportunity to receive the training after the study period is over.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OKQ Training Program

The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female
* 18-49 years old
* Receiving either primary or obstetric/gynecology care at one of the study clinics

Exclusion Criteria

* Male
* Pregnant
* \<18 years old \>49 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role collaborator

Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Emily White VanGompel

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily White VanGompel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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Northshore University HealthSystem

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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Williams L, Zapata LB, D'Angelo DV, Harrison L, Morrow B. Associations between preconception counseling and maternal behaviors before and during pregnancy. Matern Child Health J. 2012 Dec;16(9):1854-61. doi: 10.1007/s10995-011-0932-4.

Reference Type BACKGROUND
PMID: 22173331 (View on PubMed)

Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, Lee J, Schillinger D, Steinauer J. Association of the quality of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016 Jul;215(1):78.e1-9. doi: 10.1016/j.ajog.2016.01.173. Epub 2016 Jan 28.

Reference Type BACKGROUND
PMID: 26827879 (View on PubMed)

Dehlendorf C, Krajewski C, Borrero S. Contraceptive counseling: best practices to ensure quality communication and enable effective contraceptive use. Clin Obstet Gynecol. 2014 Dec;57(4):659-73. doi: 10.1097/GRF.0000000000000059.

Reference Type BACKGROUND
PMID: 25264697 (View on PubMed)

Shannon GD, Alberg C, Nacul L, Pashayan N. Preconception healthcare and congenital disorders: systematic review of the effectiveness of preconception care programs in the prevention of congenital disorders. Matern Child Health J. 2014 Aug;18(6):1354-79. doi: 10.1007/s10995-013-1370-2.

Reference Type BACKGROUND
PMID: 24091886 (View on PubMed)

Temel S, van Voorst SF, Jack BW, Denktas S, Steegers EA. Evidence-based preconceptional lifestyle interventions. Epidemiol Rev. 2014;36:19-30. doi: 10.1093/epirev/mxt003. Epub 2013 Aug 28.

Reference Type BACKGROUND
PMID: 23985430 (View on PubMed)

Mohllajee AP, Curtis KM, Morrow B, Marchbanks PA. Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol. 2007 Mar;109(3):678-86. doi: 10.1097/01.AOG.0000255666.78427.c5.

Reference Type BACKGROUND
PMID: 17329520 (View on PubMed)

Gavin L, Moskosky S, Carter M, Curtis K, Glass E, Godfrey E, Marcell A, Mautone-Smith N, Pazol K, Tepper N, Zapata L; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: Recommendations of CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014 Apr 25;63(RR-04):1-54.

Reference Type BACKGROUND
PMID: 24759690 (View on PubMed)

Bello JK, Rao G, Stulberg DB. Trends in contraceptive and preconception care in United States ambulatory practices. Fam Med. 2015 Apr;47(4):264-71.

Reference Type BACKGROUND
PMID: 25853596 (View on PubMed)

Bellanca HK, Hunter MS. ONE KEY QUESTION(R): Preventive reproductive health is part of high quality primary care. Contraception. 2013 Jul;88(1):3-6. doi: 10.1016/j.contraception.2013.05.003. Epub 2013 May 11. No abstract available.

Reference Type BACKGROUND
PMID: 23773527 (View on PubMed)

Allen D, Hunter MS, Wood S, Beeson T. One Key Question(R): First Things First in Reproductive Health. Matern Child Health J. 2017 Mar;21(3):387-392. doi: 10.1007/s10995-017-2283-2.

Reference Type BACKGROUND
PMID: 28220337 (View on PubMed)

Frayne DJ, Verbiest S, Chelmow D, Clarke H, Dunlop A, Hosmer J, Menard MK, Moos MK, Ramos D, Stuebe A, Zephyrin L. Health Care System Measures to Advance Preconception Wellness: Consensus Recommendations of the Clinical Workgroup of the National Preconception Health and Health Care Initiative. Obstet Gynecol. 2016 May;127(5):863-872. doi: 10.1097/AOG.0000000000001379.

Reference Type BACKGROUND
PMID: 27054935 (View on PubMed)

Rocca CH, Ralph LJ, Wilson M, Gould H, Foster DG. Psychometric Evaluation of an Instrument to Measure Prospective Pregnancy Preferences: The Desire to Avoid Pregnancy Scale. Med Care. 2019 Feb;57(2):152-158. doi: 10.1097/MLR.0000000000001048.

Reference Type BACKGROUND
PMID: 30550399 (View on PubMed)

Ferketa M, Schueler K, Song B, Carlock F, Stulberg DB, White VanGompel E. Facilitators of and Barriers to Successful Implementation of the One Key Question(R) Pregnancy Intention Screening Tool. Womens Health Rep (New Rochelle). 2022 Mar 8;3(1):326-334. doi: 10.1089/whr.2021.0100. eCollection 2022.

Reference Type DERIVED
PMID: 35415707 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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EH18-343

Identifier Type: -

Identifier Source: org_study_id