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Improving Contraceptive Care for Women With Medical Conditions

2 juli 2020 bijgewerkt door: Justine Wu, University of Michigan

Improving Contraceptive Care for Women With Chronic Conditions: A Novel, Web-Based Decision Aid in Primary Care

The purpose of this project is to describe how contraceptive services are currently being delivered to women with medical conditions who seek care in community-based primary care settings, such as family medicine and internal medicine clinical offices.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This pilot study seeks to:

1. To understand women's beliefs, attitudes, and experiences with contraception in context of their medical conditions, drug therapy, personal preferences, and current experiences in primary care.

b. To describe provider- To describe provider- and practice-level factors that impact the delivery of contraceptive services in primary care.

To seek the perspectives of multiple stakeholders: 1) women aged 18-50 with one or more medical conditions; and 2) practice members who consist of primary care providers (PCPs) and office staff (e.g. nurses, medical assistants, and administrative staff members). The specific objective of this formative, qualitative study is to identify key patient-, provider-, and practice-level factors that are critical to the delivery of contraceptive counseling and services to women with medical conditions.

To accomplish these aims, qualitative data will be collected in clinical settings that currently provide primary care and family planning for reproductive-aged women with medical conditions. Data collected will be: 1) in-depth interviews with women with medical conditions and practice members; and 2) semi-structured observations of office activities and processes (e.g. patient check in, patient scheduling).

Using rigorous qualitative mixed methods to collect and analyze data, a deeper understanding will be gained of factors that should be considered in the design and implementation of future interventions to improve contraceptive care for women with medical conditions in primary care.

Studietype

Observationeel

Inschrijving (Werkelijk)

67

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48104
        • Department of Family Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Identification of primary care practices (5-10) that provide primary care services and provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) within southeast Michigan. Primary care physicians (30) and medical staff (30) within the primary care practices identified for recruitment will be approached for interviews. Approximately 30 women will be approached about participation in the study after the approval of the primary care physician. A convenience sampling approach will be used.

Beschrijving

Patients:

To be eligible for the study, the patient must meet all the following criteria:

  • Able to speak English
  • Able to give informed consent
  • Have at least one significant medical condition (defined as any condition that requires medication management and/or active monitoring, like hypertension, diabetes) that would pose greater than average risk to the woman during pregnancy, including the use of medications that could be associated with potential fetal harm in the event of unplanned pregnancy (defined as medications that are Pregnancy Category C, D, or X).

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded:

  • surgically or medically sterile or whose current male partner(s) are surgically or medically sterile
  • females under 18 years are excluded because prior literature has shown that their healthcare and pregnancy-related experiences differ substantially enough from those of adult women.

Practice Members Inclusion Criteria:

To be eligible for the study, the practice member must meet all the following criteria:

  • Age 18 or older
  • Able to speak English
  • Able to give informed consent
  • Indirectly or directly involved with patient care

Primary Practices:

To be eligible for the study, primary care practices must meet all the following criteria:

  • currently provide primary care services to reproductive-aged women aged 18-45
  • currently provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) on site OR refer patients to another site.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients
Women with chronic medical conditions
Gedragsmatig: Interview
1 hour semi-structured
Primary Care Providers and Medical Staff

Primary care providers can include doctors and advanced practice professionals, including midwives, nurse practitioners, and physician assistants.

Medical staff can include social workers, nurses, medical assistants, and administrative staff
Gedragsmatig: Interview
1 hour semi-structured
Primary Practice
Primary care practices (family medicine, internal medicine, medicine-pediatric, or any combination of these) that at a practice-level already provide contraceptive counseling and services to reproductive-age women
Gedragsmatig: Observation
Field Observation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Factors To Guide the Design of Contraceptive Design Application
Tijdsspanne: 6 months
A semi-structured interview will be used to identify patient-, provider- and practice-level factors that are relevant to the design and implementation of a contraceptive decision aid.
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Onderzoekers

  • Hoofdonderzoeker: Justine P WU, MD, University of Michigan

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 september 2017

Primaire voltooiing (Werkelijk)

30 juni 2020

Studie voltooiing (Werkelijk)

30 juni 2020

Studieregistratiedata

Eerst ingediend

12 mei 2017

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2017

Eerst geplaatst (Werkelijk)

15 mei 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2020

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2020

Laatst geverifieerd

1 juli 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HUM0012060
  • 1K23HD084744-01A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Final sets of data may be shared for use via a signed Data Sharing Agreement.

  1. The organizations in the project remain the full/joint owners of such data.
  2. One of the following two conditions must be met: a. No personal health identifiers are included in the final data set; b. Appropriate patient consent and institutional review board waiver has been obtained for all identifiable data
  3. All data transferred will be in an encrypted format and stored securely.
  4. Both parties agree not to release information about specific identifiable subjects to anyone.
  5. Both parties agree to the boundary conditions of the original proposal under which data sharing was initiated.
  6. Both parties agree to support of the pertinent grant awards as part of published acknowledgments section for any document shared under this agreement.
  7. All publications arising from this shared data set must be reviewed and approved by Principle Investigator of the study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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