An interventional study of OKQ Training Program in Reproductive Health, sponsored by Endeavor Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by Endeavor Health · Not applicable, Interventional, and Prevention
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.
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.
Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.
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.
Time frame: After the clinic has implemented OKQ for at least 4 weeks
Receipt of Contraceptive Counseling
Among patients with potential to become pregnant, the rate of survey respondents who received any contraceptive counseling.
Time frame: 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.
Time frame: After the clinic has implemented OKQ for at least 4 weeks
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.
Time frame: 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.
Time frame: After the clinic has implemented OKQ for at least 4 weeks
| Milestone | Interventional Practices | Control Practices |
|---|---|---|
| Started | 69 | 74 |
| Completed | 69 | 74 |
| Not completed | 0 | 0 |
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.
| Participants | Interventional Practices | Control Practices |
|---|---|---|
| Receipt of Any Reproductive Health Counseling | 54 | 38 |
Among patients with potential to become pregnant, the rate of survey respondents who received any contraceptive counseling.
| Participants | Interventional Practices | Control Practices |
|---|---|---|
| Receipt of Contraceptive Counseling | 45 | 33 |
Among patients with potential to become pregnant, percent of respondents who received any preconception counseling.
| Participants | Interventional Practices, Clinics Receiving One Key Question Training | Control Practices, Clinics Not Receiving One Key Question Training |
|---|---|---|
| Receipt of Preconception Counseling | 26 | 13 |
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.
| Participants | Interventional Practices | Control Practices |
|---|---|---|
| Patient Satisfaction With Overall Care | 67 | 57 |
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.
| Participants | Interventional Practices | Control Practices |
|---|---|---|
| Patient Satisfaction-Improving Their Health | 64 | 54 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional Practices | — | — | — |
| Control Practices | — | — | — |
Baseline data was based upon the characteristics of 4 clinics. The 4 clinics continued their participation for the duration of Phase 2 of the study. The interventional as well as the control group each consisted of one family medicine practice, and one OB/GYN practice. At baseline, a total of 69 subjects participated in the interventional group, and a total of 74 subjects participated in the control group.
| Age, Customized(Participants) | Interventional Practices | Control Practices | Total |
|---|---|---|---|
| Count of participants | 69 | 74 | 143 |
| Sex: Female, Male(Participants) | Interventional Practices | Control Practices | Total |
|---|---|---|---|
| Female | 69 | 74 | 143 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Interventional Practices | Control Practices | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 11 | 25 |
| Not Hispanic or Latino | 46 | 58 | 104 |
| Unknown or Not Reported | 9 | 5 | 14 |
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