Contraceptive Equity Study 2016

NCT ID: NCT03012659

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1015 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-07-31

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.

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).

Conditions

Contraception Behavior; Contraceptive Usage; Contraceptive Method Switching

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm

Full-day contraceptive counseling training for health center staff

Group Type: EXPERIMENTAL

Contraceptive Counseling Training

Intervention Type: BEHAVIORAL

Intervention sites will receive:

1. In person training: All staff at an intervention health center will participate in a one-day counseling training.

2. 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.

3. Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.

Control Arm

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Contraceptive Counseling Training

Intervention sites will receive:

1. In person training: All staff at an intervention health center will participate in a one-day counseling training.

2. 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.

3. Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Non-English speakers

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Planned Parenthood South Atlantic

UNKNOWN

Sponsor Role: collaborator

Planned Parenthood Federation of America

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hannah R. Simons, DrPH

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood Federation of America

Locations

Planned Parenthood South Atlantic

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

Pro00019792

Identifier Type: -

Identifier Source: org_study_id