An Electronic Medical Record Alert of Progesterone

NCT03219489 | Completed

• 1 other identifier: EMR Alert
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Progesterone can be given to women at risk for preterm birth, and is advocated by many guidelines as progesterone has been shown to markedly decrease preterm birth, death in newborns, and disability. However, not all eligible women are currently receiving this medication. Thus, there is an urgent need to improve prevention of preterm birth with progesterone. In response to the low number of women receiving this medication, the investigators have designed a potential method to increase progesterone use. This method involves the use of an "alert" programmed into electronic medical records, to prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a randomized controlled trial that will assess the feasibility of using this "alert", by randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal care. The investigators will then study whether the alert improved prescription of progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care providers will be asked for their feedback and thoughts about the alert, through questionnaires and structured interviews. The investigators hypothesize that the electronic medical record alert will increase care provider recommendations and prescription of progesterone for women at risk of preterm birth. The investigators hope that this study will lay the groundwork for larger future studies aimed to strengthen health care quality and improve the health outcomes of women and their babies.

Conditions

Preterm Birth; Pregnancy

Keywords

Electronic Medical Record; Progesterone

Outcome Measures

Primary Outcomes (2)

• Feasibility of the intervention, assessed by proportions of successful implementation and recommendation by care providers

  Feasibility of the intervention will assessed by the proportion (%) of clinics which successfully implement the intervention (the electronic medical record alert), and the proportion (%) of care providers who would recommend the alert to colleagues. The intervention will be defined as feasible if \>80% of clinics successfully implement the alert, and if \>80% of care providers would recommend the alert to colleagues.

  10 months

• Feasibility of a cluster RCT, assessed by proportions of clinics agreeing to participation and completeness of outcome data

  Feasibility of a cluster RCT will be assessed by the proportion (%) of approached clinics which agree to participate in the study, and by the proportion (%) of outcome data which is complete. The cluster RCT will be defined as feasible if \>80% of approached clinics agree to study participation, and if \>80% of outcome data is complete.

  10 months

Secondary Outcomes (5)

• Process outcomes - rates of progesterone offer and usage

  10 months

• Care provider ratings of acceptability, feasibility, and usefulness, assessed by survey

  10 months

• Barriers to the intervention (qualitative measures), assessed by survey and interview

  10 months

• Facilitators to the intervention (qualitative measures), assessed by survey and interview

  10 months

• Perceptions of the effectiveness of the intervention (qualitative measures), assessed by survey and interview

  10 months

Study Arms (2)

Intervention

EXPERIMENTAL

Clinics randomized to intervention will use the electronic medical record alert for progesterone, informed by guidelines and the foundational meta-analyses demonstrating its efficacy.

Other: Electronic medical record alert

Control

NO INTERVENTION

Clinics randomized to control will not use the electronic medical record alert for progesterone. The control group will receive the usual prenatal care.

Interventions

Electronic medical record alert OTHER

An electronic medical record alert will be inserted into the clinic's electronic medical records. The alert reads: "Consider Progesterone 100-200 mg pv qhs \> or =16 weeks, if previous spontaneous PTB or current short cervix, and no allergies to peanuts or progesterone." This alert will appear on the Ministry of Health-mandated Perinatal Records.

Intervention

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For clinics:
• Usage of an EMR with the ability to have alerts inserted and that is searchable.
• Location in Ontario (for proximity to the researchers),
• Have a clinician willing to serve as the local site lead, and
• Lack of an existing alert for progesterone.
• For patients:
• Women at risk of spontaneous preterm birth, based on \>1 of the following criteria:
• previous preterm birth \<37 weeks,
• a short cervix defined as \<25 mm by transvaginal ultrasound during the current pregnancy.
• One or two viable fetus(es) between 12 weeks + 0 days to 24 weeks + 6 days gestation.

You may not qualify if:

• For patients:
• Women with triplets or other higher order multiples,
• Women with a miscarriage or termination of pregnancy, or
• Women with a pregnancy with a known lethal fetal anomaly.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4K1, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sarah D McDonald, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 17, 2017
• Study Start: October 5, 2017
• Primary Completion: December 3, 2018
• Study Completion: December 3, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)