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Completed

NCT Number: NCT03947788

One Key Question: Pilot Study at NorthShore

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.

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Receipt of Any Reproductive Health Counseling

    Time frame: After 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 outcomes

  1. Receipt of Contraceptive Counseling

    Time frame: After 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.

  2. Receipt of Preconception Counseling

    Time frame: After 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.

Other outcomes

  1. Patient Satisfaction With Overall Care

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

    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.

  2. Patient Satisfaction-Improving Their Health

    Time frame: After the clinic has implemented OKQ for at least 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • University of Chicago

Registry information

Official study title

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

Acronym: OKQ2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 13, 2019
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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