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Improving Contraceptive Counseling in the United States (ICC)

31. oktober 2022 opdateret af: New York University
This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1418

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10001
        • New York University, Silver School of Social Work

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 30 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

  • Not seeking contraception from clinic on day of recruitment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.
Adfærdsmæssigt: Evidence informed birth control counseling
Counselors underwent training on the use of 10 best practices for contraceptive counseling.
Andre navne:
  • Improving contraceptive counseling in the United States
Ingen indgriben: No intervention
The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.
Tidsramme: immediately after counseling session
immediately after counseling session
Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Tidsramme: immediately after counseling session
immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Tidsramme: immediately after counseling session
immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.
Tidsramme: 6 months from initial clinic visit
6 months from initial clinic visit
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.
Tidsramme: one year from initial clinic visit
one year from initial clinic visit

Sekundære resultatmål

Resultatmål
Tidsramme
Type of contraceptive method currently using (including none and dual use) as assessed by a questionnaire designed for this study (e.g., what method of birth control are you currently using).
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit

Andre resultatmål

Resultatmål
Tidsramme
Method switching for pill users as assessed by a questionnaire designed for this study asking current method used at posttest to determine if it is no longer the pill using questions designed for this study
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit
Gaps in pregnancy protection (number of weeks not using any birth control during contraceptive method switches as assessed by a questionnaire designed for this study using retrospective recall
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit
Counselor behavior (topics covered during counseling) as assessed by a questionnaire designed for this study asking if counselor did or did not address key topics about method use
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit
Pill users retrospective report of the number of missed pills using a questionnaire designed for this study
Tidsramme: six months to one year from initial clinic visit
six months to one year from initial clinic visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

New York University

Samarbejdspartnere

Planned Parenthood Federation of America

Efterforskere

  • Ledende efterforsker: James J Jaccard, PhD, New York University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

2. juni 2016

Først indsendt, der opfyldte QC-kriterier

11. juni 2016

Først opslået (Skøn)

15. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2022

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FPRPA006057
  • 12-9103 (Anden identifikator: NYU Committee on Activities Involving Human Subjects)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Behandling som sædvanlig

Kliniske forsøg med Evidence informed birth control counseling

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