Trial Outcomes & Findings for One Key Question: Pilot Study at NorthShore (NCT NCT03947788)
NCT ID: NCT03947788
Last Updated: 2021-12-03
Results Overview
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.
COMPLETED
NA
143 participants
After the clinic has implemented OKQ for at least 4 weeks
2021-12-03
Participant Flow
Participant milestones
| Measure |
Interventional Practices
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.
OKQ Training Program: The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.
|
Control Practices
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
74
|
|
Overall Study
COMPLETED
|
69
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One Key Question: Pilot Study at NorthShore
Baseline characteristics by cohort
| Measure |
Interventional Practices
n=69 Participants
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.
|
Control Practices
n=74 Participants
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.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Count of participants
|
69 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After the clinic has implemented OKQ for at least 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Interventional Practices
n=69 Participants
Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received the One Key Question training program).
Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks.
|
Control Practices
n=74 Participants
Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).
Patients at the control practices were surveyed to demonstrate that contraception counseling rates remained unchanged at clinics not receiving the One Key Question training program.
|
|---|---|---|
|
Receipt of Any Reproductive Health Counseling
|
54 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: After the clinic has implemented OKQ for at least 4 weeksPopulation: 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.
Among patients with potential to become pregnant, the rate of survey respondents who received any contraceptive counseling.
Outcome measures
| Measure |
Interventional Practices
n=69 Participants
Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received the One Key Question training program).
Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks.
|
Control Practices
n=74 Participants
Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).
Patients at the control practices were surveyed to demonstrate that contraception counseling rates remained unchanged at clinics not receiving the One Key Question training program.
|
|---|---|---|
|
Receipt of Contraceptive Counseling
|
45 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: After the clinic has implemented OKQ for at least 4 weeksPopulation: 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.
Among patients with potential to become pregnant, percent of respondents who received any preconception counseling.
Outcome measures
| Measure |
Interventional Practices
n=69 Participants
Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received the One Key Question training program).
Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks.
|
Control Practices
n=74 Participants
Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).
Patients at the control practices were surveyed to demonstrate that contraception counseling rates remained unchanged at clinics not receiving the One Key Question training program.
|
|---|---|---|
|
Receipt of Preconception Counseling
|
26 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Interventional Practices
n=69 Participants
Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received the One Key Question training program).
Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks.
|
Control Practices
n=74 Participants
Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).
Patients at the control practices were surveyed to demonstrate that contraception counseling rates remained unchanged at clinics not receiving the One Key Question training program.
|
|---|---|---|
|
Patient Satisfaction With Overall Care
|
67 Participants
|
57 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After the clinic has implemented OKQ for at least 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Interventional Practices
n=69 Participants
Patient recruitment for the intervention group occurred at the two clinics (one Family Medicine, one OB/GYN), that participated in the intervention (received the One Key Question training program).
Patients at the intervention practices were surveyed to determine if there was an improved rate of received contraception counseling, following each clinic's implementation of the intervention for 4-6 weeks.
|
Control Practices
n=74 Participants
Patient recruitment for the control group occurred at the two clinics (one Family Medicine, one OB/GYN), that did not participate in the intervention (did not receive One Key Question training program).
Patients at the control practices were surveyed to demonstrate that contraception counseling rates remained unchanged at clinics not receiving the One Key Question training program.
|
|---|---|---|
|
Patient Satisfaction-Improving Their Health
|
64 Participants
|
54 Participants
|
Adverse Events
Interventional Practices
Control Practices
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emily White VanGompel
NorthShore University HealthSystem
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place