Evaluation of a Decision Aid for Early Pregnancy Loss

Early Pregnancy Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410029
• Other study ID #: 842526
• Status: Completed
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: March 25, 2021

Study information

• Verified date: March 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 25, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Early Pregnancy Loss
• Fetal Death

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision Conflict Scale (DCS)	Low-literacy version of Decision Conflict Scale	Post-counseling (one day)