One Key Question: Pilot Study at NorthShore

Study Overview
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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.

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

Conditions
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Reproductive Health

Intervention / Treatment
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* Behavioral: OKQ Training Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Practices<br>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<br>* The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.<br>|
| No Intervention: Control Practices<br>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?
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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 |