Collaborative Efforts to Increase Flu Vaccination (CollabFlu)
Strategies to Vaccinate All Children for Influenza in a Practice Setting
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
- 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.
- 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.
- 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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80010
- Tri County Health dept
-
Aurora, Colorado, Vereinigte Staaten, 80012
- Aurora Family Medicine
-
Aurora, Colorado, Vereinigte Staaten, 80014
- Forum Family Medicine
-
Brighton, Colorado, Vereinigte Staaten, 80601
- Premier Pediatrics
-
Broomfield, Colorado, Vereinigte Staaten, 80021
- Indian Crest Pediatrics
-
Centennial, Colorado, Vereinigte Staaten, 80112
- Pediatrics 5280
-
Centennial, Colorado, Vereinigte Staaten, 80014
- Centennial Pediatrics
-
Centennial, Colorado, Vereinigte Staaten, 80015
- Advanced Pediatrics
-
Centennial, Colorado, Vereinigte Staaten, 80112
- Greenwood Pediatrics
-
Centennial, Colorado, Vereinigte Staaten, 80112
- Pediatric Pathways
-
Denver, Colorado, Vereinigte Staaten, 80246
- CIIS
-
Englewood, Colorado, Vereinigte Staaten, 80113
- Hampden Medical Group
-
Ft. Morgan, Colorado, Vereinigte Staaten, 80701
- Family Practice Clinic
-
Ft. Morgan, Colorado, Vereinigte Staaten, 80701
- Ft. Morgan Medical Group
-
Haxtun, Colorado, Vereinigte Staaten, 80731
- Haxtun Family Medicine
-
Julesburg, Colorado, Vereinigte Staaten, 80737
- Valley Medical Center
-
Lakewood, Colorado, Vereinigte Staaten, 80215
- Jefferson County Health dept
-
Lakewood, Colorado, Vereinigte Staaten, 80226
- Kids First
-
Lakewood, Colorado, Vereinigte Staaten, 80401
- Denver West Pediatrics
-
Littleton, Colorado, Vereinigte Staaten, 80123
- Focus on Kids
-
Lone Tree, Colorado, Vereinigte Staaten, 80124
- Lone Tree Family Medicine
-
Parker, Colorado, Vereinigte Staaten, 80138
- Crown Point Pediatrics
-
Sterling, Colorado, Vereinigte Staaten, 80751
- Northeast County Health Dept
-
Thornton, Colorado, Vereinigte Staaten, 80260
- Mountain Land Pediatrics
-
Wheat Ridge, Colorado, Vereinigte Staaten, 80033
- Pediatrics West
-
Wray, Colorado, Vereinigte Staaten, 80758
- Wray Clinic
-
Yuma, Colorado, Vereinigte Staaten, 80759
- Yuma Clinic
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
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.
|
|
Sonstiges: Usual care
Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.
|
This group will continue administering influenza vaccine to their patients in their practice as they normally do.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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.
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
high-risk children receipt of influenza vaccination
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Allison Kempe, MD, MPH, University of Colorado, Children's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 10-0589
- 1U01IP000320 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .