One Key Question: Pilot Study at NorthShore (OKQ2)

One Key Question-System Team Patient: A Pilot Study Phase II

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.

Study Overview

• Status: Completed
• Conditions: Reproductive Health
• Intervention / Treatment: Behavioral: OKQ Training Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: OKQ Training Program; The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of Contraceptive Counseling	Among patients with potential to become pregnant, the rate of survey respondents who received any contraceptive counseling.	After the clinic has implemented OKQ for at least 4 weeks
Receipt of Preconception Counseling	Among patients with potential to become pregnant, percent of respondents who received any preconception counseling.	After the clinic has implemented OKQ for at least 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Overall Care	This outcome measure can be described as the distribution of patient responses (extremely satisfied, very satisfied, satisfied, very dissatisfied, extremely dissatisfied) when asked about satisfaction with overall medical care during their visit. This outcome was measured as a count of patients that reported being very or extremely satisfied with the overall care provided at their visit that day.	After the clinic has implemented OKQ for at least 4 weeks.
Patient Satisfaction-Improving Their Health	This outcome measure can be described as the distribution of patient responses (extremely satisfied, very satisfied, satisfied, very dissatisfied, extremely dissatisfied) when asked about satisfaction with the way their provider talked with them about improving their health. This outcome was measured as a count of patients that reported being very or extremely satisfied with the way their provider talked with them about improving their health.	After the clinic has implemented OKQ for at least 4 weeks

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Collaborators: University of Chicago
• Investigators: Principal Investigator: Emily White VanGompel, MD, MPH, Northshore University Healthsystem

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Med Care. 2019 Jul;57(7):566.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2019
• Primary Completion (ACTUAL): January 6, 2021
• Study Completion (ACTUAL): January 6, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (ACTUAL): May 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EH18-343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No