Professional Abstract

Objective

To compare the effectiveness of a patient-facing intervention and a provider-facing intervention, both alone and together, for supporting shared decision making (SDM) about birth control methods during healthcare visits versus usual care alone

Study Design

Design Elements	Description
Design	Cluster randomized trial
Population	5,018 patients ages 15–49 who were assigned female sex at birth
Interventions/ Comparators	Patient-facing video plus prompt card Decision aids plus provider-facing training materials Patient-facing video plus prompt card and decision aids plus provider-facing training materials Usual care alone (no video, prompt card, decision aids, or training)
Outcomes	Primary: patient-reported SDM about birth control methods Secondary: patient-reported outcomes pertaining to the discussion of birth control methods, the birth control methods intended and used, satisfaction and regret, and pregnancy
Timeframe	Immediate follow-up after healthcare visit for primary outcome

This cluster randomized controlled trial assessed the effectiveness of a patient-facing intervention and a provider-facing intervention at facilitating SDM for birth control methods during healthcare visits. After accounting for clinics’ baseline use of SDM, researchers randomly assigned 16 clinics to one of four groups.

• Clinics received a video for patients to watch on a tablet immediately before their healthcare visit. The video coached patients to ask three specific questions that apply to any healthcare decision. Clinics also received prompt cards for patients to remind them of the questions.
• Clinics received seven decision aids with training materials that included a video and written guidance on their use during healthcare visits. Each of six decision aids covered a single category of birth control methods, and the seventh gave an overview of the categories.
• Clinics received both the video and prompt cards and the decision aids and training materials.
• Clinics did not receive the video and prompt card or the decision aids and training materials.

Researchers asked clinics to implement their assigned interventions for six months; clinics provided usual contraceptive care throughout the remainder of the study. All patient-facing materials were available in English and Spanish.

The study included 5,018 patients who had a healthcare visit at one of 16 clinics in the northeast United States. Among these, 87% identified as White, 3% as Black or African American, 3% as Asian, 1% as American Indian or Alaska Native, <1% as Native Hawaiian or Other Pacific Islander, 2% as some other race, and 4% as two or more races. Also, 93% identified as not being of Hispanic, Latino, or Spanish origin and 7% identified as being of Hispanic, Latino, or Spanish origin.

Participants completed surveys immediately, four weeks, and six months after the healthcare visit.

Patients, patient advocates, providers, and researchers conducted the study.

Results

The groups did not differ significantly on patient-reported SDM about birth control methods or on any of the secondary outcomes. Patient-reported data suggested that the intervention implementation was suboptimal.

Limitations

Participant retention was lower than expected, which may have limited the study’s ability to detect differences in secondary outcomes.

Conclusions and Relevance

The interventions studied are unlikely to have a meaningful population-wide impact on SDM in real-world care in the absence of additional strategies to support implementation.

Future Research Needs

Future research could continue to explore methods for supporting SDM about birth control methods.