Reproductive Health
Conditions
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.
Interventions
BEHAVIORALOKQ Training Program
The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.
Sponsors
University of Chicago
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Any Reproductive Health Counseling | 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
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Contraceptive Counseling | 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. |
| Receipt of Preconception Counseling | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Overall Care | 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. |
| Patient Satisfaction-Improving Their Health | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional Practices The staff at these two clinics which included physicians, clinical and administrative staff; received the One Key Question in-person training program, delivered by Power to Decide.
OKQ Training Program: The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care. | 69 |
| Control Practices These two clinics did not receive the One Key Question training program during the study period. They were offered the training after the study period was over. | 74 |
| Total | 143 |
Baseline characteristics
| Characteristic | Interventional Practices | Control Practices | Total |
|---|---|---|---|
| Age, Customized Count of participants | 69 Participants | 74 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 11 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 58 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Female | 69 Participants | 74 Participants | 143 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: The population analyzed included patients with the ability to get pregnant that were between the ages of 18-49 years old. Patients that reported experiencing menopause, hysterectomy, or sterilization were excluded from analysis. Patients that were pregnant were not eligible for participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Practices | Receipt of Any Reproductive Health Counseling | 54 Participants |
| Control Practices | Receipt of Any Reproductive Health Counseling | 38 Participants |
Secondary
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
Population: The population analyzed included patients with the ability to get pregnant that were between the ages of 18-49 years old. Patients that reported experiencing menopause, hysterectomy, or sterilization were excluded from analysis. Patients that were pregnant were not eligible for participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Practices | Receipt of Contraceptive Counseling | 45 Participants |
| Control Practices | Receipt of Contraceptive Counseling | 33 Participants |
Secondary
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
Population: The population analyzed included patients with the ability to get pregnant that were between the ages of 18-49 years old. Patients that reported experiencing menopause, hysterectomy, or sterilization were excluded from analysis. Patients that were pregnant were not eligible for participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Practices | Receipt of Preconception Counseling | 26 Participants |
| Control Practices | Receipt of Preconception Counseling | 13 Participants |
Other Pre-specified
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
Population: The population analyzed included patients with the ability to get pregnant that were between the ages of 18-49 years old. Patients that reported experiencing menopause, hysterectomy, or sterilization were excluded from analysis. Patients that were pregnant were not eligible for participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Practices | Patient Satisfaction-Improving Their Health | 64 Participants |
| Control Practices | Patient Satisfaction-Improving Their Health | 54 Participants |
Other Pre-specified
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.
Population: The population analyzed included patients with the ability to get pregnant that were between the ages of 18-49 years old. Patients that reported experiencing menopause, hysterectomy, or sterilization were excluded from analysis. Patients that were pregnant were not eligible for participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Practices | Patient Satisfaction With Overall Care | 67 Participants |
| Control Practices | Patient Satisfaction With Overall Care | 57 Participants |