ContraceptionIMPACCTNCT02364037

Innovative Model of Patient-Centered ConTraception

A study testing CHOICE Project Structured Contraceptive Counseling, Contraceptive Education Session and Cost Support for IUDs and implants in people with Contraception and Unintended Pregnancy, run by Washington University School of Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception, Unintended Pregnancy
What is being tested?: CHOICE Project Structured Contraceptive Counseling, Contraceptive Education Session and Cost Support for IUDs and implants
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,008 participants
Where: 3 sitesUnited States
Study dates: Aug 2013to 31 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 45 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

14-45 years of age
Does not desire pregnancy during the next 12 months
Desires reversible contraception
Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months
Willing and able to undergo informed consent
Willing to comply with study protocol and 1-year follow-up schedule
Not currently pregnant
Current patient at Family Care Carondelet, Family Care Forest Park Southeast, Memphis Health Center

Who cannot join

Has undergone a female sterilization procedure such as tubal ligation or hysterectomy
Has one sexual partner who has undergone a vasectomy procedure
Speaks language other than English or Spanish
Currently using an IUD or implant as her contraceptive method

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Memphis Health Center
Memphis, Tennessee, 38126
Family Care Health Center Forest Park
St Louis, Missouri, 63110
Family Care Health Center Carondelet
St Louis, Missouri, 63111

Other trials in United States

About this study

Official title: Implementation of Patient-Centered Contraception Provision in Community Settings

This study is testing models of contraceptive care that were developed as part of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4) reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that interventions such as comprehensive contraceptive counseling, increased access, and removal of financial barriers increase the uptake of LARC methods and reduce unintended pregnancy. The investigators objective is to determine whether the CHOICE model of contraceptive care can be equally successful in the real world of community clinics.

Read the detailed description

This project involves comparing two models of contraceptive care; 'enhanced care' which is usual care plus the CHOICE structured contraceptive counseling, and the 'complete CHOICE' group which includes the structured contraceptive counseling as well as provider training and cost support for IUDs and implants. Participants will be enrolled at three partner community clinics by a staff member (site coordinator) dedicated to the research study. All participants will undergo contraceptive counseling as well as a baseline survey with the coordinator. Participants will complete telephone surveys at 3, 6, and 12 months post-enrollment and will be asked about contraceptive method chosen, satisfaction and continuation of the method, and any pregnancies experienced since enrollment.

Conditions: Contraception, Unintended Pregnancy
Being tested: CHOICE Project Structured Contraceptive Counseling, Contraceptive Education Session, Cost Support for IUDs and implants
Keywords: intrauterine device, subdermal implant, contraceptive counseling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHOICE Project Structured Contraceptive CounselingBehavioural
Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
Contraceptive Education SessionBehavioural
Prior to Phase 2, health care providers at the recruitment sites will undergo a contraceptive education session with a focus on evidence-based provision of contraception including LARC (IUDs and implant) and same-day insertion.
Cost Support for IUDs and implantsDevice
Women in Phase 2 of the study who desire an IUD or implant can receive one through the study at no cost if they do not have insurance coverage. If women have insurance that covers the device, her insurance will be billed for the cost of the device.

Study groups in NCT02364037
Study group	Role	What they receive
Phase 1: Enhanced Care	Other	Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs. Receives: Behavioral: CHOICE Project Structured Contraceptive Counseling
Phase 2: Complete CHOICE	Other	Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage. Receives: Behavioral: CHOICE Project Structured Contraceptive Counseling; Behavioral: Contraceptive Education Session; Device: Cost Support for IUDs and implants

What is being measured

The primary outcome is the main question the study is designed to answer.

Unintended Pregnancy
The number of self-reported unintended pregnancies.
Measured: 12 months

Secondary outcomes (4)

Contraceptive Method Use Upon Enrollment Completion
This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method.
Measured: On the day of enrollment
Desired Contraceptive Method at Enrollment Visit
This could be a new method, an existing method, or nothing if participant did not choose a method
Measured: On the day of enrollment
Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
Number of women choosing an IUD or implant as their preferred contraceptive method
Measured: On the day of enrollment
Same Day LARC Insertion
Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.
Measured: On the day of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201331 Oct 2017

First posted16 Feb 2015 (estimated)
Study startAug 2013
Primary completion1 Jan 2017
Study completion31 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Model description: We used a prospective, controlled time-trend study design, a non-randomized design where outcomes are compared before and after a change in the healthcare setting.
Masking: None (open label)
Enrolment: 1,008 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02364037
Sponsor's protocol ID: 201402021
Other IDs: PCORI-CD-12-11-4586
Acronym: IMPACCT
Status last verified: May 2020
First submitted: 9 Feb 2015
Last updated: 2 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Madden T, Paul R, Maddipati R, Buckel C, Goodman M, Peipert JF. Comparison of unintended pregnancy at 12 months between two contraceptive care programs; a controlled time-trend design. Contraception. 2019 Sep;100(3):196-201. doi: 10.1016/j.contraception.2019.05.009. Epub 2019 May 24.
PubMed 31132346
Buckel C, Maddipati R, Goodman M, Peipert JF, Madden T. Effect of staff training and cost support on provision of long-acting reversible contraception in community health centers. Contraception. 2019 Apr;99(4):222-227. doi: 10.1016/j.contraception.2018.12.005. Epub 2019 Jan 24.
PubMed 30685287

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception

All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Patient-Centered Contraception Provision in Community Settings
ClinicalTrials.gov ID: NCT02364037
Acronym / sponsor ID: IMPACCT / 201402021
Conditions: Contraception, Unintended Pregnancy
Keywords: intrauterine device, subdermal implant, contraceptive counseling
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,008 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Family Care Health Centers, Memphis Health Center, A Step Ahead Foundation, Patient-Centered Outcomes Research Institute
Study start: Aug 2013
Primary completion: 1 Jan 2017 (actual)
Study completion: 31 Oct 2017 (actual)
First posted: 16 Feb 2015 (estimated)
Results: Posted 3 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: We used a prospective, controlled time-trend study design, a non-randomized design where outcomes are compared before and after a change in the healthcare setting.

Arm	Type	Receives
Phase 1: Enhanced Care	Other	Behavioral: CHOICE Project Structured Contraceptive CounselingWomen in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs.
Phase 2: Complete CHOICE	Other	Behavioral: CHOICE Project Structured Contraceptive Counseling, Behavioral: Contraceptive Education Session, Device: Cost Support for IUDs and implantsWomen in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.

Who may qualify

Ages: 14 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

14-45 years of age
Does not desire pregnancy during the next 12 months
Desires reversible contraception
Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months
Willing and able to undergo informed consent

Key exclusion criteria (4 listed)

Has undergone a female sterilization procedure such as tubal ligation or hysterectomy
Has one sexual partner who has undergone a vasectomy procedure
Speaks language other than English or Spanish
Currently using an IUD or implant as her contraceptive method

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHOICE Project Structured Contraceptive CounselingWomen in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.	Behavioural	Phase 1: Enhanced Care, Phase 2: Complete CHOICE
Contraceptive Education SessionPrior to Phase 2, health care providers at the recruitment sites will undergo a contraceptive education session with a focus on evidence-based provision of contraception including LARC (IUDs and implant) and same-day insertion.	Behavioural	Phase 2: Complete CHOICE
Cost Support for IUDs and implantsWomen in Phase 2 of the study who desire an IUD or implant can receive one through the study at no cost if they do not have insurance coverage. If women have insurance that covers the device, her insurance will be billed for the cost of the device.	Device	Phase 2: Complete CHOICE

Primary outcome

Unintended Pregnancy
Time frame: 12 months
The number of self-reported unintended pregnancies.

4 secondary outcomes

Contraceptive Method Use Upon Enrollment Completion
Time frame: On the day of enrollment
Desired Contraceptive Method at Enrollment Visit
Time frame: On the day of enrollment
Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
Time frame: On the day of enrollment
Same Day LARC Insertion
Time frame: On the day of enrollment

Results and safety

Results posted to the registry on 3 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Enhanced Care	502	458
Phase 2: Complete CHOICE	506	453

Primary outcome: Unintended Pregnancy

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Phase 1: Enhanced Care n = 502	Phase 2: Complete CHOICE n = 506
Value	46	25

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Enhanced Care	0 of 502 (0%)	0 of 502 (0%)	Not reported
Phase 2: Complete CHOICE	0 of 506 (0%)	0 of 506 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31132346Madden T, Paul R, Maddipati R, Buckel C, Goodman M, Peipert JF. Comparison of unintended pregnancy at 12 months between two contraceptive care programs; a controlled time-trend design. Contraception. 2019 Sep;100(3):196-201. doi: 10.1016/j.contraception.2019.05.009. Epub 2019 May 24.
Derived from this study: PubMed 30685287Buckel C, Maddipati R, Goodman M, Peipert JF, Madden T. Effect of staff training and cost support on provision of long-acting reversible contraception in community health centers. Contraception. 2019 Apr;99(4):222-227. doi: 10.1016/j.contraception.2018.12.005. Epub 2019 Jan 24.

Related trials for Contraception

RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tessa Madden, MD/MPH principal investigator

Washington University School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unintended Pregnancy (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364037, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.