Linking inter-professional newborn and contraception care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine well-baby visits
{"title":"Linking inter-professional newborn and contraception care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine well-baby visits","authors":"Sadia Haider , Emily Ott , Amy Moore , Kristin Rankin , Rebecca Campbell , Nivedita Mohanty , Jena Wallander Gemkow , Rachel Caskey","doi":"10.1016/j.cct.2024.107659","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes. Despite this, nearly one third of U.S. women experience a short IPI.</p></div><div><h3>Objective</h3><p>To address the gap in the current model of postpartum (PP) contraception care by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care to improve access to timely PP contraception.</p></div><div><h3>Methods</h3><p>The LINCC Trial will take place in seven clinical locations across five community health centers within the U.S. PP patients (planned <em>n</em> = 3150) who are attending a Well-Baby Visit between 0 and 6 months will be enrolled. The LINCC Trial aims to leverage the Electronic Health Record to prompt providers to ask PP patients attending a Well-Baby Visit about their PP contraception needs and facilitate co-scheduling of PP contraception care with routine newborn care visits. The study includes a cluster randomized, cross-sectional stepped wedge design to roll out the intervention across the seven sites. The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies. Implementation outcomes will be assessed at baseline and 6 months after site enters intervention period.</p></div><div><h3>Conclusions</h3><p>The LINCC Trial seeks to evaluate the effectiveness and feasibility of a linked care model in comparison to usual care.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107659"},"PeriodicalIF":2.0000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002428","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes. Despite this, nearly one third of U.S. women experience a short IPI.
Objective
To address the gap in the current model of postpartum (PP) contraception care by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care to improve access to timely PP contraception.
Methods
The LINCC Trial will take place in seven clinical locations across five community health centers within the U.S. PP patients (planned n = 3150) who are attending a Well-Baby Visit between 0 and 6 months will be enrolled. The LINCC Trial aims to leverage the Electronic Health Record to prompt providers to ask PP patients attending a Well-Baby Visit about their PP contraception needs and facilitate co-scheduling of PP contraception care with routine newborn care visits. The study includes a cluster randomized, cross-sectional stepped wedge design to roll out the intervention across the seven sites. The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies. Implementation outcomes will be assessed at baseline and 6 months after site enters intervention period.
Conclusions
The LINCC Trial seeks to evaluate the effectiveness and feasibility of a linked care model in comparison to usual care.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.