이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Collaborative Efforts to Increase Flu Vaccination (CollabFlu)

2015년 5월 29일 업데이트: University of Colorado, Denver

Strategies to Vaccinate All Children for Influenza in a Practice Setting

Beginning with the 2009-2010 season, influenza vaccine is universally recommended for children age 6 months to 18 years old, placing extra burden on health care providers across the U.S. The focus of this study is to develop new strategies and implement existing evidence-based strategies to enhance influenza immunization in these children. The intervention will involve collaboration from different types of primary care providers, the Colorado Immunization Information System (CIIS), public health departments and visiting nursing services (VNA). It will be designed and implemented by those involved with delivery with a focus on sustainability after the completion of the study. Parental input will be gathered during the planning year through focus groups to assist in developing the intervention. Qualitative assessments and examination of processes during the first year of implementation will guide modifications during the second implementation year in order to assure sustainability. Primary outcome measures in the intervention and control groups: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 mo.-18 yr. and 2) increase in the rate of children 6 mo.-18 yr. who were fully immunized (received all required influenza injections) during the season. 3) measure outcomes by age group (6 mo.-5 yr., 6-8 yr., 9-12 yr., 13-18 yr.) and types of clinical sites (urban Peds, urban FM, rural FM)

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Specific Aim 1: Within each of three types of clinical sites (urban pediatric, urban family medicine, and rural family medicine) recruit a group of similar practices (Year 1) 1a. Randomize practices within each type of clinical site to either the intervention or the control group

1b. Establish private-public collaborations for influenza vaccination delivery between county public health departments, visiting nursing associations and each of the intervention practices within the three clinical site types

Specific Aim 2: Conduct focus groups among parents of children seen at intervention practices, to assess attitudes and perceived barriers to possible practice-based and collaborative strategies to promote influenza vaccination (Year 1)

Specific Aim 3: Develop (Year 1) and implement (Years 2 and 3) a plan for comprehensive and collaborative delivery of influenza vaccine at intervention practices 3a. Develop practice-based intervention strategies focusing primarily on immunization of high-risk patients 3b. Develop private-public collaborative interventions between the intervention practices, their county public health department and visiting nursing associations focusing primarily on immunization of school-aged children 3c. Implement (Years 2 and 3) both practice-based and private-public collaborative strategies in the intervention practices while monitoring only in the control practices

Specific Aim 4: Conduct a group-randomized trial to evaluate and compare the effectiveness of the comprehensive delivery model in improving influenza vaccination coverage for children 6 months to 18 years in three different types of clinical sites (urban pediatric, urban family medicine, and rural family medicine).

4a. Evaluate effectiveness of the comprehensive delivery model at each of the three types of clinical sites

  1. Compare the following primary outcome measures in the intervention and control groups: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years and 2) increase in the rate of children 6 months to 18 years who were fully immunized (received all required influenza injections) during the season.
  2. Compare the following secondary outcome measures: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children and 2) increase in the rate of high-risk children who were fully immunized during the season.
  3. Evaluate sustainability of the comprehensive delivery model on the above outcome measures

4b. Compare the effectiveness of the comprehensive delivery model in three different types of clinical sites (urban pediatric private practice, urban family medicine private practice, and rural family medicine private practice)

Specific Aim 5: Evaluate the process of implementation of the comprehensive delivery model for influenza delivery in each of the three types of sites.

5a. Assess process measures relevant to implementation of practice-based interventions and compare by type of clinical site 5b. Assess process measures relevant to implementation of private-public collaborative interventions and compare by type of clinical site 5c. Using key informant interviews, assess perceptions regarding facilitators and barriers to private-public collaborative delivery, alternative methods and means of improving the process among practice providers, administrators and among participating public health and visiting nurse personnel

Specific Aim 6: In two urban pediatric intervention practices and one rural family medicine practice, conduct surveys examining parental attitudes about methods of influenza delivery and their experience with their practice's participation in a comprehensive and collaborative private-public model for influenza delivery

Major Hypotheses:

SA4. Hypothesis 1. Effectiveness on receipt of ≥1 influenza vaccine: The increase in the likelihood of receiving ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices.

SA4. Hypothesis 2 Effectiveness - fully immunized: The increase in the likelihood of receiving all necessary influenza vaccines during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices.

SA4. Hypothesis 3. Effectiveness by age strata: The increase in the likelihood of receiving ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children in each of the following age strata will be greater in intervention than in control practices: 1) 6 months through 5 years; 2) 6 through 8 years; 3) 9 through 12 years; 4) 13 through 18 years.

SA4. Hypothesis 4. Effectiveness in high-risk children: The increase in the likelihood of receiving of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children 6 months to 18 years will be greater for high-risk children in intervention practices than in control practices.

SA4. Hypothesis 5. Sustainability: The increase in the likelihood of receiving ≥1 influenza vaccine during the second post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices. (Sustainability will also be evaluated for other outcomes above.)

SA4. Hypothesis 6. Differential effectiveness by clinical site type: The increase in the likelihood of receiving of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years for intervention vs. controls will differ by clinical site type

연구 유형

중재적

등록 (실제)

117175

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Colorado
      • Aurora, Colorado, 미국, 80010
        • Tri County Health dept
      • Aurora, Colorado, 미국, 80012
        • Aurora Family Medicine
      • Aurora, Colorado, 미국, 80014
        • Forum Family Medicine
      • Brighton, Colorado, 미국, 80601
        • Premier Pediatrics
      • Broomfield, Colorado, 미국, 80021
        • Indian Crest Pediatrics
      • Centennial, Colorado, 미국, 80112
        • Pediatrics 5280
      • Centennial, Colorado, 미국, 80014
        • Centennial Pediatrics
      • Centennial, Colorado, 미국, 80015
        • Advanced Pediatrics
      • Centennial, Colorado, 미국, 80112
        • Greenwood Pediatrics
      • Centennial, Colorado, 미국, 80112
        • Pediatric Pathways
      • Denver, Colorado, 미국, 80246
        • CIIS
      • Englewood, Colorado, 미국, 80113
        • Hampden Medical Group
      • Ft. Morgan, Colorado, 미국, 80701
        • Family Practice Clinic
      • Ft. Morgan, Colorado, 미국, 80701
        • Ft. Morgan Medical Group
      • Haxtun, Colorado, 미국, 80731
        • Haxtun Family Medicine
      • Julesburg, Colorado, 미국, 80737
        • Valley Medical Center
      • Lakewood, Colorado, 미국, 80215
        • Jefferson County Health dept
      • Lakewood, Colorado, 미국, 80226
        • Kids First
      • Lakewood, Colorado, 미국, 80401
        • Denver West Pediatrics
      • Littleton, Colorado, 미국, 80123
        • Focus on Kids
      • Lone Tree, Colorado, 미국, 80124
        • Lone Tree Family Medicine
      • Parker, Colorado, 미국, 80138
        • Crown Point Pediatrics
      • Sterling, Colorado, 미국, 80751
        • Northeast County Health Dept
      • Thornton, Colorado, 미국, 80260
        • Mountain Land Pediatrics
      • Wheat Ridge, Colorado, 미국, 80033
        • Pediatrics West
      • Wray, Colorado, 미국, 80758
        • Wray Clinic
      • Yuma, Colorado, 미국, 80759
        • Yuma Clinic

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

6개월 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Children age 6 mo - 18 yr in up to 20 practices

Exclusion Criteria:

  • Infants under the age of 6 mo or adults over the age of 18

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Increasing flu vaccination
Collect from billing records in the 10 intervention practice sites to test for an increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years during the season. The interventions include: 1. Develop practice-based intervention strategies (like use of reminder-recall of children due for influenza,2. Develop Private/public collaboration to increase flu vaccination between the intervention practices, their county public health department and visiting nursing associations, and 3. Implement both practice-based and private-public collaborative strategies in the intervention practices while monitoring only in the control practices
행동: Private/public collaboration to increase flu vaccination
Intervention practices will develop office-based interventions including methods to identify high-risk patients within their practices and methods of maximizing the immunization of these children within the practice, use of patient reminders, after-hours influenza clinics, walk-in provision of influenza vaccine and increased focus on education regarding the need for immunization. The practices will also collaborate with their county public health departments and visiting nursing associations to develop private-public collaborative interventions that may include large clinics for school-aged children for multiple practices and tracking of influenza supplies and redistribution of influenza vaccine between practices when supplies are delayed or inadequate.
다른: Usual care
Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.
다른: Usual care
This group will continue administering influenza vaccine to their patients in their practice as they normally do.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Evaluate the effectiveness of collaborations between public and private entities to increase influenza vaccination in children 6 mos to 18 yrs in 10 intervention sites in 3 counties throughout the state of CO during the '10-11 & '11-12 flu seasons.
기간: Up to 4 months post intervention (December 2012)
Primary outcome measure is to increase the rate of receipt of ≥1 influenza vaccine during the post-intervention year(s) compared to the pre-intervention year among children 6 mos.-18 yrs in 10 intervention sites. Intervention practices will collaborate with their respective health departments and/or the VNA to help assist with the increase in volume of patients needing to be vaccinated against flu in the 2010-2011 and the 2011-2012 flu seasons. Billing data will be obtained from all 20 sites (intervention+control) and compared to evaluate the effectiveness of this collaboration.
Up to 4 months post intervention (December 2012)

2차 결과 측정

결과 측정
측정값 설명
기간
high-risk children receipt of influenza vaccination
기간: baseline and intervention years 1 and 2
increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children
baseline and intervention years 1 and 2
high-risk children fully immunized during influenza season
기간: baseline and intervention years 1 and 2
increase in the rate of high-risk children who were fully immunized during the season.
baseline and intervention years 1 and 2

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Colorado, Denver

협력자

Centers for Disease Control and Prevention

수사관

  • 수석 연구원: Allison Kempe, MD, MPH, University of Colorado, Children's Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 8월 1일

기본 완료 (실제)

2015년 2월 1일

연구 완료 (실제)

2015년 3월 1일

연구 등록 날짜

최초 제출

2011년 7월 14일

QC 기준을 충족하는 최초 제출

2011년 7월 25일

처음 게시됨 (추정)

2011년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 5월 29일

마지막으로 확인됨

2015년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 10-0589
  • 1U01IP000320 (미국 NIH 보조금/계약)

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. .

구독하다