One Key Question: Pilot Study at NorthShore

NCT03947788 | Completed Results

• 1 other identifier: EH18-343
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reproductive Health

Outcome Measures

Primary Outcomes (1)

• Receipt of Any Reproductive Health Counseling

  Among patients with potential to become pregnant, percent of respondents who received any reproductive health counseling. Counts as "Yes" for this outcome if they received any contraceptive counseling or any preconception counseling.

  After the clinic has implemented OKQ for at least 4 weeks

Secondary Outcomes (2)

• Receipt of Contraceptive Counseling

  After the clinic has implemented OKQ for at least 4 weeks

• Receipt of Preconception Counseling

  After the clinic has implemented OKQ for at least 4 weeks

Other Outcomes (2)

• Patient Satisfaction With Overall Care

  After the clinic has implemented OKQ for at least 4 weeks.

• Patient Satisfaction-Improving Their Health

  After the clinic has implemented OKQ for at least 4 weeks

Study Arms (2)

Interventional Practices

EXPERIMENTAL

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.

Behavioral: OKQ Training Program

Control Practices

NO INTERVENTION

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.

Interventions

OKQ Training Program BEHAVIORAL

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

Interventional Practices

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years old
• Receiving either primary or obstetric/gynecology care at one of the study clinics

You may not qualify if:

• Male
• Pregnant
• \<18 years old \>49 years old

Sponsors & Collaborators

• Endeavor Health: lead
• University of Chicago: collaborator

Study Sites (1)

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (13)

• 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.

  PMID: 22173331 BACKGROUND

• 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.

  PMID: 26827879 BACKGROUND

• 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.

  PMID: 25264697 BACKGROUND

• 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.

  PMID: 24091886 BACKGROUND

• 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.

  PMID: 23985430 BACKGROUND

• 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.

  PMID: 17329520 BACKGROUND

• 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.

  PMID: 24759690 BACKGROUND

• 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.

  PMID: 25853596 BACKGROUND

• 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.

  PMID: 23773527 BACKGROUND

• 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.

  PMID: 28220337 BACKGROUND

• 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.

  PMID: 27054935 BACKGROUND

• 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.

  PMID: 30550399 BACKGROUND

• 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.

  PMID: 35415707 DERIVED

Results Point of Contact

• Title: Emily White VanGompel
• Organization: NorthShore University HealthSystem

ewhitevangompel@northshore.org

224-364-7300

Study Officials

• Emily White VanGompel, MD, MPH

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: January 17, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: December 3, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)