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One Key Question: Pilot Study at NorthShore

Not Applicable
Completed
Conditions
Reproductive Health
Registration Number
NCT03947788
Lead Sponsor
NorthShore University HealthSystem
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
143
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Receipt of Any Reproductive Health CounselingAfter the clinic has implemented OKQ for at least 4 weeks

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.

Secondary Outcome Measures
NameTimeMethod
Receipt of Contraceptive CounselingAfter the clinic has implemented OKQ for at least 4 weeks

Among patients with potential to become pregnant, the rate of survey respondents who received any contraceptive counseling.

Receipt of Preconception CounselingAfter the clinic has implemented OKQ for at least 4 weeks

Among patients with potential to become pregnant, percent of respondents who received any preconception counseling.

Trial Locations

Locations (1)

Northshore University HealthSystem

🇺🇸

Evanston, Illinois, United States

Northshore University HealthSystem
🇺🇸Evanston, Illinois, United States
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