Clinical trial NCT03012659: Contraceptive Equity Study 2016
Official title: Contraceptive Equity Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraception Behavior
Contraceptive Usage
Contraceptive Method Switching
Keywords: contraceptive counseling
cluster randomized trial
provider counseling training
Lead sponsor: Planned Parenthood Federation of America
Sponsor class: OTHER
Collaborators: name: Planned Parenthood South Atlantic
First posted: 2017-01-06
Enrollment: 1015
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Contraceptive Continuation
timeFrame: 3 months
Secondary outcomes:
measure: Method Satisfaction
timeFrame: 1 month and 3 months
measure: Dual-Use
timeFrame: 1 month and 3 months
measure: Missed Pills
timeFrame: 1 month and 3 months
measure: Method Switching
timeFrame: 1 month and 3 months
measure: Patient experience of counseling best practices during their visit
timeFrame: Baseline
Other outcomes:
measure: Access to same-day services for all contraceptive methods
timeFrame: Baseline
Locations:
city: Raleigh
country: United States
facility: Planned Parenthood South Atlantic
state: North Carolina
Study officials:
affiliation: Planned Parenthood Federation of America
name: Hannah R. Simons, DrPH
role: PRINCIPAL_INVESTIGATOR
References: