Randomized control trial of a decision aid for early pregnancy loss management

Awarded 2020
Complex Family Planning Fellowship Research
Anne Flynn, MD
University of Pennsylvania

Background: Early pregnancy loss (EPL) can safely be managed surgically, medically, or expectantly, and patient preferences, together with provider recommendations, should be used to guide treatment decisions. The management options differ substantially experientially, and both patients and providers acknowledge the complexity of the treatment choice. Decision aids provide evidence-based information, enhance expectation management, result in increase in value-aligned decisions, and decrease decisional conflict. The utility of a decision aid in EPL treatment setting has not been tested. Thus, our objective is to compare decision conflict scores (DCS) in patients using a validated decision aid for EPL management to the scores of patients receiving standard counseling.
Design and Methods: Our hypothesis is that women who receive a decision aid will have a mean DCS 5.75 points lower than controls. We will conduct a randomized control trial using the Healthwise decision aid available within the electronic medical record at the Hospital of the University of Pennsylvania (HUP). The Healthwise Decision Aid EPL tool receives the highest score in on International Patient Decision Aid Standards Scale. We will randomize 88 EPL patients, 5-12 completed weeks gestation, to receive counseling with or without the decision aid. The primary outcome will be the decisional conflict score. Secondary outcomes will include the shared decision-making process scale (SDM-Q-9), knowledge of treatment options, short assessment of patient satisfaction (SAPS) and clinical visit time.
Potential Impact: Our study will assess the effect of the Healthwise Decision Aid for EPL on decision conflict, patient experience, and consultation visit time. This study has the potential to help improve the care delivered to women with EPL.