Evidence map›Paper›PMID 37940161›Full record

ArticleBMJ open2023

Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes.

Stacy C Bailey, Allison P Pack, Guisselle Wismer, Norma Calderon, Evelyn Velazquez, Stephanie Batio, Abbey Ekong, Alice Eggleston, Amisha Wallia, Michael S Wolf and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04976881 (Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 73% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04976881 naactive not recruitingnot on this map

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial

TypeinterventionalSponsorNorthwestern UniversityRan2022 to 2027Enrolled840ConditionsDiabetes Mellitus, Type 2, Electronic Health Record, Primary Health Care, Reproductive BehaviorArmsMedication Reconciliation (MedRec) Tool, Provider Alert and Decision Support, PREPSheet, Text Messaging
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.

  1. Guideline
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Stacy C BaileyDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA stacy-bailey@northwestern.edu.ORCID 0000-0002-2566-3789
Allison P PackDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Guisselle WismerDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Norma CalderonDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Evelyn VelazquezDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Stephanie BatioDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Abbey EkongAllianceChicago, Chicago, Illinois, USA.
Alice EgglestonAllianceChicago, Chicago, Illinois, USA.
Amisha WalliaDivision of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.ORCID 0000-0002-3183-4062
Michael S WolfDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Jacob M SchauerDepartment of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Sandi TenfeldeFamily and Community Health Department, Marcella Niehoff School of Nursing, Loyola University Chicago, Chicago, Illinois, USA.
David M LiebovitzDivision of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.ORCID 0000-0002-2518-5940
William A GrobmanDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.
Northwestern University · USLoyola University Chicago · USThe Ohio State University · US

Funding

Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Research Design, Data, and Analytics CoreP30DK092949 · NIDDK · UNIVERSITY OF CHICAGO · PI ELBERT S. HUANG · 2011 to 2026
$10.0M
The Claude D. Pepper Older Americans Independence Center (OAIC) at Northwestern UniversityP30AG059988 · NIA · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LINDER, JEFFREY A., WOLF, MICHAEL S · 2020 to 2024
$7.1M
Promoting Preconception Care and Diabetes Self-Management among Reproductive-Aged Women with Diabetes: The PREPARED TrialR01DK127184 · NIDDK · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BAILEY, STACY C · 2021 to 2025
$3.2M
NCATS NIH HHS UL1 TR001422NIA NIH HHS P30 AG059988NIDDK NIH HHS P30 DK092949NIDDK NIH HHS R01 DK127184
6 · The paper itself

Abstract

introductionWomen with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care. METHODS AND ANALYSIS: We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to 'hardwire' preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18-44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic's assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects. ETHICS AND DISSEMINATION: This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04976881).

Indexed as

Diabetes Mellitus, Type 2ContraceptionFemaleFolic AcidHumansPreconception CarePregnancyRandomized Controlled Trials as TopicReproductionFolic Aciddiabetes in pregnancyhealth informaticshealth literacyrandomized controlled trial

Identifiers

PMID37940161
PMCPMC10632823
OpenAlexW4388500277

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.