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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Practices | Experimental | 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. |
|
| Control Practices | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OKQ Training Program | Behavioral | The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Emily White VanGompel, MD, MPH | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northshore University HealthSystem | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22173331 | Background | Williams L, Zapata LB, D'Angelo DV, Harrison L, Morrow B. Associations between preconception counseling and maternal behaviors before and during pregnancy. Matern Child Health J. 2012 Dec;16(9):1854-61. doi: 10.1007/s10995-011-0932-4. | |
| 26827879 | Background | Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, Lee J, Schillinger D, Steinauer J. Association of the quality of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016 Jul;215(1):78.e1-9. doi: 10.1016/j.ajog.2016.01.173. Epub 2016 Jan 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | After the clinic has implemented OKQ for at least 4 weeks |
|
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All-cause Mortality, Serious, and Other [non-serious] Adverse Events were not monitored/assessed. This study was determined to be minimal risk with the potential for loss of confidentiality being the only risk to subjects. Monitoring subjects for All-cause Mortality, Serious, and Other Adverse Events was not required for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily White VanGompel | NorthShore University HealthSystem | 224-364-7300 | ewhitevangompel@northshore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2019 | Sep 21, 2020 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2020 | Jan 28, 2021 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2018 | Sep 21, 2020 | ICF_002.pdf |
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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 |
| 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. | After the clinic has implemented OKQ for at least 4 weeks |
| 25264697 | Background | Dehlendorf C, Krajewski C, Borrero S. Contraceptive counseling: best practices to ensure quality communication and enable effective contraceptive use. Clin Obstet Gynecol. 2014 Dec;57(4):659-73. doi: 10.1097/GRF.0000000000000059. |
| 24091886 | Background | Shannon GD, Alberg C, Nacul L, Pashayan N. Preconception healthcare and congenital disorders: systematic review of the effectiveness of preconception care programs in the prevention of congenital disorders. Matern Child Health J. 2014 Aug;18(6):1354-79. doi: 10.1007/s10995-013-1370-2. |
| 23985430 | Background | Temel S, van Voorst SF, Jack BW, Denktas S, Steegers EA. Evidence-based preconceptional lifestyle interventions. Epidemiol Rev. 2014;36:19-30. doi: 10.1093/epirev/mxt003. Epub 2013 Aug 28. |
| 17329520 | Background | Mohllajee AP, Curtis KM, Morrow B, Marchbanks PA. Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol. 2007 Mar;109(3):678-86. doi: 10.1097/01.AOG.0000255666.78427.c5. |
| 24759690 | Background | Gavin L, Moskosky S, Carter M, Curtis K, Glass E, Godfrey E, Marcell A, Mautone-Smith N, Pazol K, Tepper N, Zapata L; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: Recommendations of CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014 Apr 25;63(RR-04):1-54. |
| 25853596 | Background | Bello JK, Rao G, Stulberg DB. Trends in contraceptive and preconception care in United States ambulatory practices. Fam Med. 2015 Apr;47(4):264-71. |
| 23773527 | Background | Bellanca HK, Hunter MS. ONE KEY QUESTION(R): Preventive reproductive health is part of high quality primary care. Contraception. 2013 Jul;88(1):3-6. doi: 10.1016/j.contraception.2013.05.003. Epub 2013 May 11. No abstract available. |
| 28220337 | Background | Allen D, Hunter MS, Wood S, Beeson T. One Key Question(R): First Things First in Reproductive Health. Matern Child Health J. 2017 Mar;21(3):387-392. doi: 10.1007/s10995-017-2283-2. |
| 27054935 | Background | Frayne DJ, Verbiest S, Chelmow D, Clarke H, Dunlop A, Hosmer J, Menard MK, Moos MK, Ramos D, Stuebe A, Zephyrin L. Health Care System Measures to Advance Preconception Wellness: Consensus Recommendations of the Clinical Workgroup of the National Preconception Health and Health Care Initiative. Obstet Gynecol. 2016 May;127(5):863-872. doi: 10.1097/AOG.0000000000001379. |
| 30550399 | Background | Rocca CH, Ralph LJ, Wilson M, Gould H, Foster DG. Psychometric Evaluation of an Instrument to Measure Prospective Pregnancy Preferences: The Desire to Avoid Pregnancy Scale. Med Care. 2019 Feb;57(2):152-158. doi: 10.1097/MLR.0000000000001048. |
| 35415707 | Derived | Ferketa M, Schueler K, Song B, Carlock F, Stulberg DB, White VanGompel E. Facilitators of and Barriers to Successful Implementation of the One Key Question(R) Pregnancy Intention Screening Tool. Womens Health Rep (New Rochelle). 2022 Mar 8;3(1):326-334. doi: 10.1089/whr.2021.0100. eCollection 2022. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control Practices | 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. |
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| Secondary | Receipt of Contraceptive Counseling | Among patients with potential to become pregnant, the rate of survey respondents who received any contraceptive counseling. | 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. | Posted | Count of Participants | Participants | After the clinic has implemented OKQ for at least 4 weeks |
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|
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| Secondary | Receipt of Preconception Counseling | Among patients with potential to become pregnant, percent of respondents who received any preconception counseling. | 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. | Posted | Count of Participants | Participants | After the clinic has implemented OKQ for at least 4 weeks |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | After the clinic has implemented OKQ for at least 4 weeks. |
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| 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. | 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. | Posted | Count of Participants | Participants | After the clinic has implemented OKQ for at least 4 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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