- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04269616
Order Effects of Prematurity Outcome Data
The Effect of Order of Presenting Survival and Disability Information for Periviable Births on Participant Treatment Choice
Women recruited from the internet were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age.
Participants were randomized to receive these pictographs in a different order (survival or disability first) and to receive descriptiveness level of survival (just numerical information, or also description of course of NICU stay).
Participants were then asked to choose between comfort care and intensive care in this situation. Participants' religiosity, value of the sanctity of life, and health literacy were also assessed.
연구 개요
상태
정황
상세 설명
The National Institute of Child Health and Human Development (NICHD) Workshop on Periviable Birth recommended that information on the chance of survival and risk of disability should be provided separately. The order in which information is presented can affect memory, persuasiveness, and treatment choice, but the effect of order of information presentation in the context of neonatal resuscitation has received little attention. Additionally, the effect of including a description of the long and intense time in the neonatal intensive care unit (NICU) on parental treatment decision making is also unexplored. Current evidence suggests that pictographs best convey numerical information to parents.
Three pictographs were developed based on NICHD data for 22 weeks gestational age (GA) babies who received intensive care. One pictograph displayed information on the rates of disability in the babies who survive. Two pictographs displayed information about how many babies born at 22 weeks survive, with one of these pictographs including a description of the average course of NICU stay.
An internet survey was sent to a U.S. representative sample of women of child-bearing age. A vignette including background on prematurity and the treatment options of intensive care or comfort care for a baby born at 22 weeks GA was presented. Participants viewed the pictographs, evenly randomized to one of four experimental conditions (order of information presentation x level of description of NICU course). Participants were then asked to choose intensive care or comfort care. Participant religiosity, values (quality vs. sanctity of life), autonomy preferences in medical decision making, previous NICU exposure, numeracy, and health literacy were also assessed.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women of childbearing age (defined as 18-50) living in the U.S.
Exclusion Criteria:
- Minors, those unable to read English, and those who only could complete the survey on their phone. (For formatting purposes, a tablet or computer was necessary.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Numerical survival, followed by disability information
Participants in this arm were presented with a pictograph displaying numerical survival information, followed by a pictograph displaying disability information.
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The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
|
실험적: Survival with description, followed by disability information
Participants in this arm were presented with a pictograph displaying survival information including the average course of stay in the NICU, followed by a pictograph displaying disability information.
|
The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
|
실험적: Disability information, followed by numerical survival
Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying numerical survival.
|
The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
|
실험적: Disability information, followed by survival with description
Participants in this arm were presented with a pictograph displaying disability information, followed by a pictograph displaying survival information including the average course of stay in the NICU.
|
The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e.
survival or disability information first).
The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e.
only numerical data, or also a description of course of NICU stay).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hypothetical treatment choice
기간: Assessed immediately post-intervention.
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Participant's hypothetical treatment choice of either comfort care or intensive care.
Participants were told: "Your doctor asks you what treatment option you want to choose," and given the options of "I would want the doctors to provide the baby intensive care / comfort care."
This dichotomous variable is assessed for the frequency of each option chosen.
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Assessed immediately post-intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
광적인 신앙
기간: 개입 후 평가, 치료 선택 직후.
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참가자의 종교성은 Duke University Religion Index(5개 항목)를 사용하여 평가되었습니다.
잠재적 점수 범위는 5-27이며 27이 가장 종교적입니다.
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개입 후 평가, 치료 선택 직후.
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Preference for medical autonomy
기간: Assessed post-intervention, immediately after treatment choice.
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Participants were asked on a 4-point scale their medical autonomy preferences, in the form of: "In making medical decisions: 1) I always prefer to have the doctor make decisions for me, 2) I would prefer to have the doctor make medical decisions for me most of the time, 3) I would prefer to make my own medical decisions most of the time, or 4) I always prefer to make my own decisions."
Score ranging from 1-4, with 4 being the maximum preference for medical autonomy.
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Assessed post-intervention, immediately after treatment choice.
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Values: quality or sanctity of life
기간: Assessed post-intervention, immediately after treatment choice.
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Participants answered the following: "In making end-of-life decisions: 1) Quality of life is much more important than preserving life, 2) Quality of life is somewhat more important than preserving life, 3) Preserving life is somewhat more important than quality of life, or 4) Preserving life is much more important than quality of life."
In the range of 1-4, a score of 4 indicated the greatest participant value of sanctity of life.
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Assessed post-intervention, immediately after treatment choice.
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Numeracy
기간: Assessed post-intervention, immediately after treatment choice.
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Participants' numeracy levels were assessed by using an adapted item from the Subjective Numeracy Scale: "How good are you at figuring out how much a $20 shirt will cost if it is 25% off?
Extremely / Quite a bit / Somewhat / A little bit / Not at all." Participants who answered somewhat, a little bit, or not at all were considered to have low numeracy.
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Assessed post-intervention, immediately after treatment choice.
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건강 지식
기간: 개입 후 평가, 치료 선택 직후.
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참가자의 건강 문해력은 단일 항목 간략한 건강 문해력 심사를 사용하여 평가되었으며, "혼자서 의료 양식을 작성하는 데 얼마나 자신이 있습니까?
매우/조금/조금/조금/전혀.” 어느 정도, 조금, 또는 전혀 응답하지 않은 응답자를 낮은 건강 리터러시로 간주했습니다.
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개입 후 평가, 치료 선택 직후.
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Previous NICU exposure
기간: Assessed post-intervention, immediately after treatment choice.
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Participants were also asked if they have previously had a child in the NICU, with yes/no answer options.
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Assessed post-intervention, immediately after treatment choice.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .