Evaluation of a Decision Aid for Early Pregnancy Loss

Evaluation of a Decision Aid for Early Pregnancy Loss: a Pilot RCT Study

This study aims to determine the effect of the Healthwise decision aid on shared decision making in women undergoing management of early pregnancy loss.

Study Overview

• Status: Completed
• Conditions: Early Pregnancy Loss
• Intervention / Treatment: Other: Healthwise Decision Aid; Other: Control informational handout

Detailed Description

Early pregnancy loss (EPL) or miscarriage is a common problem occurring in 15-20% of pregnancies. EPL can safely be managed surgically, medically, or expectantly; patient preferences, together with provider recommendations, should be used to guide treatment decisions. The three management options differ substantially experientially for patients. Previous literature has shown that patients have preferences for treatment and higher satisfaction when treated according to their preferences. Decision aids provide individualized information to help patients clarify their priorities and personal values. There is good evidence that decision aids compared to usual care resulted in greater knowledge, more realistic expectations, lower decisional conflict relating to feeling informed, more active decision making, less people remaining undecided, and greater effect agreement on value and choice. Despite this, there is limited research on the extent of decisional conflict experienced by women undergoing treatment for EPL, or the effect of decision aids on decisional conflict. Furthermore, only a few decision aid tools are publicly available for this indication. The Healthwise decision aid tool receives high scores by the International Patient Decision Aid Standards Scale, and is readily available to patients within the clinical site's electronic medical record.

The investigators propose a pilot randomized control trial, enrolling 50 participants with EPL. The study will measure baseline decisional conflict, and randomize participants to counseling with or without the decision aid. The investigators intend to study the Decisional Conflict Scale at baseline and after counseling, knowledge scores, Decision Regret and the 9-item Shared Decision Making Questionnaire (SDM-Q9) after counseling. Study data can be used to inform future research and to identify patients with predictors for high decisional conflict. This study is the first step towards validation of a high-quality decision aid tool for patients undergoing EPL management. It will also be the first study to report on decisional conflict and regret in patients with early pregnancy loss.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19143
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• English speaking
• Definitive diagnosis of early intrauterine pregnancy loss (including anembryonic pregnancy and missed abortion [ultrasound examination demonstrates fetal pole without cardiac activity measuring between 5.3 and 7mm or an abnormal growth pattern diagnostic of EPL])
• 18 years or older
• Willing and able to give informed consent

Exclusion Criteria:

• Pregnancy of unknown anatomic location
• Unable to read English
• Prior options counseling with a Family Planning provider
• Clinically unstable requiring emergent surgical management with uterine evacuation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Standard counseling + Healthwise Decision Aid	Other: Healthwise Decision Aid; Healthwise, a non-profit company that develops health content and patient information for hospitals, has created a decision aid for EPL management that is available through the EPIC Systems, an electronic medical record. Participants will be given this decision aid after EPL diagnosis and prior to options consultation with a provider.
Active Comparator: Control; Standard counseling + a control informational handout.	Other: Control informational handout; Participants randomized to the control arm will be given an informational handout of treatment options after EPL diagnosis and prior to options consultation with a provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision Conflict Scale (DCS)	Low-literacy version of Decision Conflict Scale	Post-counseling (one day)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Society of Family Planning

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Abortion, Spontaneous; Fetal Death
• Other Study ID Numbers: 842526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No