Contraceptive Equity Study 2016 (CES)

Contraceptive Equity Study

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.

Study Overview

• Status: Unknown
• Conditions: Contraception Behavior; Contraceptive Usage; Contraceptive Method Switching
• Intervention / Treatment: Behavioral: Contraceptive Counseling Training

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 Type: Interventional
• Enrollment (Actual): 1015
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Planned Parenthood South Atlantic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females who have received contraceptive counseling at participating health centers.
• Ability to understand written and spoken English.

Exclusion Criteria:

• Non-English speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraceptive Continuation	Patient-reported contraceptive continuation	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method Satisfaction	Patient-reported satisfaction with contraceptive method	1 month and 3 months
Dual-Use	Patient-reported dual-use of condoms plus other method	1 month and 3 months
Missed Pills	Number of patient-reported missed oral contraceptive pills among pill users	1 month and 3 months
Method Switching	Patient-reported method switching	1 month and 3 months
Patient experience of counseling best practices during their visit	Patient-report of staff implementation of the best counseling practices during their visit	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access to same-day services for all contraceptive methods	Patient report of being offered to start method on same day as their visit (if desired)	Baseline

Collaborators and Investigators

• Sponsor: Planned Parenthood Federation of America
• Collaborators: Planned Parenthood South Atlantic
• Investigators: Principal Investigator: Hannah R. Simons, DrPH, Planned Parenthood Federation of America

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): June 29, 2017
• Study Completion (Anticipated): July 31, 2018

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: contraceptive counseling; cluster randomized trial; provider counseling training
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: Pro00019792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO