Evaluation of a Decision Aid for Early Pregnancy Loss

NCT ID: NCT04410029

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2021-03-25

Brief 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.

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.

Conditions

Early Pregnancy Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Standard counseling + Healthwise Decision Aid

Group Type: EXPERIMENTAL

Healthwise Decision Aid

Intervention Type: OTHER

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

Standard counseling + a control informational handout.

Group Type: ACTIVE_COMPARATOR

Control informational handout

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

842526

Identifier Type: -

Identifier Source: org_study_id