October 3, 2023

Dr. Justine Wu secures $3.9 million RO1 grant to study decision-making tool to help patients with chronic conditions choose the best contraceptive fit for them

The study’s long-term goal is to improve reproductive health through person-centered contraceptive interventions in general care settings.

Justine Wu, MD, MPH, assistant professor in the Department of Family Medicine at the University of Michigan, has secured a five-year, $3.9 million RO1 grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development (part of the National Institutes of Health) for her project, “Improving contraceptive decision support for individuals with chronic conditions.”

Assistant Professor Justine Wu, MD

“Not using any contraceptive method poses the greatest risk of unplanned pregnancy and is more prevalent among those with chronic conditions,” Wu said. “There is an urgent need to support the contraceptive goals of people with chronic conditions. Our long-term goal with this study is to improve reproductive health through person-centered contraceptive interventions in general care settings.”

People with pre-existing chronic conditions are more likely to experience unplanned pregnancy and pregnancy complications than their peers without chronic conditions. A contributing factor to this is the lack of clinical resources that address the unique contraceptive decision needs of patients with chronic conditions, such as understanding which methods may improve or worsen their symptoms (such as anemia) or disease self-management (such as weight). Doctors should also help patients to understand if their chronic conditions pose a health risk in using a specific contraceptive method, and if so, what alternative methods can be used safely.

However, clinicians -- including primary care providers -- do not routinely elicit patient preferences or apply evidence-based contraceptive guidelines to counsel patients with chronic conditions.

To address these gaps, Wu and her team designed a web-based tool, My Health, My Choice (MHMC), to educate patients with chronic conditions about their contraceptive options and promote clinician adherence to contraceptive guidelines from the Centers for Disease Control and Prevention (CDC).

Her team members from U-M’s Department of Family Medicine include Ananda Sen, Ph.D., Lorraine Buis, Ph.D., James E. Aikens, Ph.D. and Tim Guetterman, Ph.D. She is joined by Vanessa Dalton, MD, of U-M’s Obstetrics and Gynecology Department and Brian Zikmund-Fisher, Ph.D., of U-M’s School of Public Health. Additionally, Natabhona Mabachi, Ph.D., director of Evaluation at the American Academy of Family Physicians (AAFP) National Research Network (NRN) and members of the DartNet Institute will be working closely to help engage with and recruit primary care clinics to the study.

 "MHMC is innovative because it is the first theory-informed, user-tested contraceptive decision support tool that targets both patients with chronic conditions and their clinicians,” Wu said.

The MHMC tool delivers contraceptive education and decision support in the context of 25 medical conditions. The tool has interactive features that can be viewed on a mobile device (iOS or Android), desktop/laptop, or tablet via a secure hyperlink.  MHMC is designed for patient use prior to a routine clinic visit to help them prepare for a contraceptive discussion with the provider.

The tool is primarily patient-facing with three modules, but also has a provider-facing interface that includes the patient’s Birth Control Summary and point-of-care clinical guidance drawn from the CDC’s contraceptive guidelines.

Building upon promising pilot study data, the RO1-funded study’s objective is to evaluate the efficacy of MHMC in a two-arm, parallel cluster-randomized trial using mixed methods to compare MHMC (the intervention) to usual contraceptive care (the control) in 14 primary care clinics that provide contraception.

“We hypothesize that MHMC use will improve patient-reported quality of contraceptive decision-making and quality of contraceptive counseling from their clinicians, which will lead to increased contraceptive use and decreased contraceptive non-use” Wu said.

The study aims are:

  • Aim 1 (Primary): To evaluate the impact of MHMC on contraceptive non-use.
  • Aim 2 (Secondary): To assess the impact of MHMC on adherence to the CDC Contraceptive Guidelines using mixed methods.
  • Aim 3: (Exploratory): To quantitatively explore decisional quality and contraceptive counseling as mediators of the effects of MHMC on primary and secondary measures.

“We expect that our study outcomes will yield new findings regarding the efficacy of MHMC for individuals with chronic conditions,” Wu said. “This project will help in the creation of scalable, person-centered contraceptive interventions for medically at-risk patients in real-world clinical settings.”

Sponsor: R01HD110570: NIH-DHHS