Results Summary and Professional Abstract

Results Summary

Download Summary Español (pdf) Audio Recording (mp3)

Results Summary

What was the research about?

Many kinds of birth control are available. Shared decision making, or SDM, can help patients choose birth control methods that are right for them. In SDM, patients and healthcare providers work together to make healthcare decisions.

In this study, the research team looked at new ways of supporting SDM about birth control methods at clinic visits. These new ways were

• A video that patients watched right before their visit. The video coached patients on asking their provider three questions before any health decision. Patients also received cards to remind them to ask these questions.
• Decision aids about birth control options. Decision aids help people choose between two or more healthcare options based on what’s most important to them.

The research team compared these new ways with usual care.

What were the results?

None of the new ways were better than usual care at supporting SDM about birth control methods.

Who was in the study?

The study included 5,018 patients. All had a visit at a clinic in the northeast United States. Of patients, 87 percent identified as White, 3 percent as Black or African American, and 3 percent as Asian. Further, 1 percent identified as American Indian or Alaska Native, less than 1 percent as Native Hawaiian or Other Pacific Islander, 2 percent as some other race, and 4 percent as two or more races. Also, 93 percent identified as not being of Hispanic, Latino, or Spanish origin while 7 percent identified as being of Hispanic, Latino, or Spanish origin.

What did the research team do?

The research team split 16 clinics into four groups according to how often they use SDM. The team assigned the groups by chance to use the video, decision aids, both, or neither. Materials were in English and Spanish. All clinics provided usual care for birth control during the study.

Patients completed surveys after their visit and four weeks and six months later.

The research team included patients, patient advocates, providers, and researchers.

What were the limits of the study?

Fewer people than expected completed the surveys, which may have affected results.

Future research could continue to look at ways to support SDM about birth control methods.

How can people use the results?

Clinics can use these results when choosing ways to support SDM about birth control methods.

Professional Abstract

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.

More on this Project  

Videos

Right For Me: Study Protocol (right)
A patient partner highlights the study protocol of this project to guide the shared decision making process between women and their healthcare providers about birth control options. Video posted with permission, courtesy of Rachel Lee Thompson.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

• The reviewers questioned the use of some of the secondary measures, specifically decision regret and values concordance, that did not seem to be validated or have established minimally clinically important differences. The researchers noted that they did not know of measures of shared decision making that had previously determined minimally clinically important differences. The researchers acknowledged that a limitation of the study was their inability to find already validated measures for some of the constructs in their study. They assured the reviewers that they considered these measures. The researchers also stated that they were collaborative in their approach to deciding on outcome measures, incorporating feedback from patient partners and from listening sessions they conducted. Co-investigators, who had expertise in patient-reported outcome measures, developed measures for adherence and values concordance. The decision regret measure would evaluate whether patients felt they made the right choice in their contraceptive method and whether they felt that there was any harm related to their contraceptive choice. The researchers felt that these topics were important in assessing contraceptive decision-making. 
• The reviewers asked whether the results were adjusted for multiple comparisons when evaluating the statistical significance of the finding that participants with lower health literacy benefited most from the shared decision making intervention. They also cautioned the researchers to not overstate the significance of these results since the primary analysis comparing the two interventions for the full sample was not significant. The researchers undertook additional analyses to adjust for multiple comparisons and the differences they saw in patient subgroups were no longer statistically significant. The researchers limited their discussion of this finding in their report but offered to provide results to readers upon request.
• The reviewers questioned whether some of the eligibility decisions led to the lack of significant results, including the heterogeneity of participating clinics and including in the sample even women who were not intending to discuss contraception during their doctors’ visits. The researchers considered the variability of the clinics to be a pragmatic decision. The researchers responded that often healthcare providers raise the issue of contraceptive decisions opportunistically, even when a patient is not considering changing methods. Moreover, decisions made in this context, even when the decisions are to stay with the current contraceptive method, are just as important to capture as decisions made when the goal of the clinic visit is to discuss contraception. Study participants who reported not having any conversation about contraception with their doctor during the clinic visit were not included in subsequent analyses on the clinic visit since they had no information.
• The reviewers expressed concern about potential confounders in study results given that the researchers obtained baseline outcome measures on a different population than the post-intervention outcome measures. The reviewers could not identify any adjustments made to account for using two different samples. The researchers corrected the text and adjusted for any differences in the distribution of covariates between the pre-intervention cohort and the post-intervention cohort.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Rachel Thompson, PhD, BPsychSci(Hons)

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

The Comparative Effectiveness of Patient- and Provider-Directed Strategies for Increasing Shared Decision-Making in Reproductive Health Care

Board Approval Date

September 2014

Project End Date

November 2020

Organization

Dartmouth College

Year Awarded

2014

State

New Hampshire

Year Completed

2020

Project Type

Research Project

Health Conditions  

Reproductive and Perinatal Health

Contraceptive Care

Intervention Strategies

Shared Decision Making
Other Health Services Interventions
Technology Interventions
Training and Education Interventions

Populations

Urban
Women

Funding Announcement

Communication and Dissemination Research

Project Budget

$2,128,816

DOI - Digital Object Identifier

10.25302/04.2021.CDR.140312221

Study Registration Information

HSRP20152114

NCT02759939