CES: Contraceptive Equity Study 2016

Sponsor
Planned Parenthood Federation of America (Other)
Overall Status
Unknown status
CT.gov ID
NCT03012659
Collaborator
Planned Parenthood South Atlantic (Other)
1,015
1
2
19.9
50.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the impact of a provider counseling training on patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10 Planned Parenthood health centers.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contraceptive Counseling Training
N/A

Detailed Description

This study builds upon prior research on a contraceptive counseling protocol and training developed and studied by partners at New York University and Planned Parenthood Federation of America. This contraceptive counseling protocol is informed by the literature on contraceptive behavior, expertise in decision and communication science, and formative qualitative research with Planned Parenthood providers and patients. Jaccard et al. (in press) conducted a cluster randomized control study of the counseling intervention with 10 Planned Parenthood health centers, where staff at intervention sites participated in a one-day training on the counseling protocol followed by a day of in-clinic shadowing. Patients were enrolled on-site and contacted for follow-up at six months and 12 months.

Results of this study indicated that patients at intervention sites were more satisfied with their contraceptive counseling and method choice, and at one or both follow-ups there were fewer gaps in contraceptive protection, more dual method use, and less non-use of birth control. There was no significant difference in accurate use of birth control pills.

Planned Parenthood Federation of America (PPFA) adapted and piloted training in this contraceptive counseling protocol during 2016 with 18 Planned Parenthood affiliated organizations across the country. This training was integrated into a one-day event that also included a provider training to address barriers in access to intrauterine devices and implants. A mixed-methods implementation evaluation was conducted to assess outcomes for staff and patients and identify challenges in implementation. Preliminary findings from the program pilot year demonstrated positive trends for outcome measures, produced lessons learned on implementation challenges, and provided support for new adaptations to the training program and counseling protocol. The previous pilot year evaluation was designed to assess patient satisfaction and method choice before and after the training, but could not answer questions about continued impact on other outcomes of interest. The current study will use a cluster randomized control design with 10 Planned Parenthood health centers to assess patient outcomes. Five health centers randomized to the intervention will receive the contraceptive counseling training. As the control group, the other five health centers will conduct usual care. Women will be enrolled onsite at the health center and then contacted for follow-up at approximately 30 and 90 days post-enrollment. Target enrollment is 100 women per site (1000 total).

Study Design

Study Type:
Interventional
Actual Enrollment :
1015 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Contraceptive Equity Study
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jun 29, 2017
Anticipated Study Completion Date :
Jul 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Arm

Full-day contraceptive counseling training for health center staff

Behavioral: Contraceptive Counseling Training
Intervention sites will receive: In person training: All staff at an intervention health center will participate in a one-day counseling training. On-site shadowing: Trainers will shadow staff in-clinic the day following the training to observe the counseling implementation and provide additional coaching and support. Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.

No Intervention: Control Arm

Usual care

Outcome Measures

Primary Outcome Measures

  1. Contraceptive Continuation [3 months]

    Patient-reported contraceptive continuation

Secondary Outcome Measures

  1. Method Satisfaction [1 month and 3 months]

    Patient-reported satisfaction with contraceptive method

  2. Dual-Use [1 month and 3 months]

    Patient-reported dual-use of condoms plus other method

  3. Missed Pills [1 month and 3 months]

    Number of patient-reported missed oral contraceptive pills among pill users

  4. Method Switching [1 month and 3 months]

    Patient-reported method switching

  5. Patient experience of counseling best practices during their visit [Baseline]

    Patient-report of staff implementation of the best counseling practices during their visit

Other Outcome Measures

  1. Access to same-day services for all contraceptive methods [Baseline]

    Patient report of being offered to start method on same day as their visit (if desired)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Females who have received contraceptive counseling at participating health centers.

  • Ability to understand written and spoken English.

Exclusion Criteria:
  • Non-English speakers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Planned Parenthood South Atlantic Raleigh North Carolina United States 27603

Sponsors and Collaborators

  • Planned Parenthood Federation of America
  • Planned Parenthood South Atlantic

Investigators

  • Principal Investigator: Hannah R. Simons, DrPH, Planned Parenthood Federation of America

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Planned Parenthood Federation of America
ClinicalTrials.gov Identifier:
NCT03012659
Other Study ID Numbers:
  • Pro00019792
First Posted:
Jan 6, 2017
Last Update Posted:
Apr 6, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Planned Parenthood Federation of America
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2018