One Key Question: Pilot Study at NorthShore (OKQ2)

NorthShore University HealthSystem

Status: Completed

Conditions: Reproductive Health

Treatments: Behavioral: OKQ Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03947788

EH18-343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Interventional Practices

Experimental group

Description:

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.

Treatment:

Behavioral: OKQ Training Program

Control Practices

No Intervention group

Description:

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.