Real-time Influenza Vaccine Surveillance

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01233388
First received: October 29, 2010
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

The aim of this proposal is to pioneer the implementation and evaluation of a novel patient centered text messaging vaccine adverse event surveillance network.


Condition Intervention
Vaccine Safety
Other: Text message surveillance

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Real-time Influenza Vaccine Surveillance: FLUNET

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of participants who report a health symptom within 6 weeks of vaccination [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    As this is a pilot study, we want to first determine if people will report health problems. Therefore, we will assess the number of participants who report a health problem within 6 weeks of vaccination.


Secondary Outcome Measures:
  • Sensitivity of the patient reporting compared to medical record [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    We will compare information provided by participants for moderate-to-severe health problems with the medical record to determine sensitivity of reporting.

  • Specificity of the patient reporting compared to medical record [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    We will compare information provided by participants for moderate-to-severe health problems with the medical record to determine specificity of reporting.


Enrollment: 400
Study Start Date: November 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Text message surveillance
enroll for text message surveillance
Other: Text message surveillance
Text message surveillance for vaccine adverse events
Other Name: Flunet

  Hide Detailed Description

Detailed Description:

The proposal will be conducted at six clinical sites of Columbia University Medical Center (CUMC), using a customized version of our already operational technology platform. Our proposed 12 month project will entail three phases: (a) 3 months of preparatory work, (b) 6 months of intervention rollout and (c) 3 months of data analysis and dissemination.

Preparatory work will include 3 areas:

Indepth interviews: We will conduct a series of interviews with patients and parents to understand their perspective on vaccine safety and Flunet. We will also interview a sample of providers to understand the most effective way for service promotion among providers. Design of registration process and messages: We will use patient/parental feedback to refine critical parts of the implementation, such as the registration process and the messages (content, frequency, format) to maximize response rates and the quality of information collected, which will be piloted in the next phase.

Technology set up and testing will occur prior to roll out in a HIPAA compliant data center. The intervention rollout will begin with a 6week refinement period. The primary goals of the refinement period are to: (1) validate/improve the methodology (e.g. registration, logic and content of the interactive menus, data collection process (2) test the application and infrastructure required for the full roll out (3) refine logistic details, such as printed materials for patients and providers. We will interview 25 patients to learn about their experience using Flunet. We will also evaluate the operations, technology and clinical findings from the intervention and incorporate any adjustments needed. After the refinement period, we will continue to monitor the systems and operations on an ongoing basis. All patients receiving a vaccine(vaccinees) will be offered the service. For children <18 years of age, a parent or guardian (parent) will be offered the service. By calling a registration number vaccinees/parents will agree to receive a series of text messages following up on the vaccinee's health.

Participating locations will include five community health centers and one hospital-based clinic, affiliated with New York Presbyterian Hospital Ambulatory Care Network (ACN) and Columbia University. These clinics include general pediatric, general medicine, Obstetric Gynecology(OBGYN)and family medicine patients. These sites are all in Health Professional Shortage Areas (HPSA).

Design and preparatory phase (months 13):

Preparatory work for implementing Flunet entails the 3 main activities: (a) Patient and provider interviews (b)Technology setup and (c) Logistic tasks.

Rollout Phase (months 39):

The roll out will entail the 3 key activities: (a) Vaccinee enrollment/registration; (b) Service delivery; (c) Refinement period and final evaluations (at 6 weeks and at the intervention end). At the beginning, we will conduct a 6 week refinement phase to validate and improve the initial design(e.g. registration methodology, best sequence and content of the interactive messages, data collection process).

The key component of the intervention is the text messaging exchange of information between our system and vaccinees. Information will comprise the following topics: (a) adverse events and (b) additional messages(primarily health tips for the influenza season). We will send a registration message and weekly messages through 6 weeks post-immunization. The first message will be sent at enrollment. Messages monitoring AEs will be sent at week 1, 2, 4, and 6, and messages containing tips and education at weeks 3 and 5. All messages detailed below are preliminary and will be modified based on feedback from vaccinees/parents obtained from the patient interviews. Messages are sent in the language selected during the telephone sign up. Additional questions will be asked only to patients reporting AEs. Messages that may trigger a reply will be designed so that vaccinees'/parents' responses are automatically parsed and replied to using a rules-based algorithm. Final messages will be based on focus group and interviews.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric, adult and OB patiente receiving an influenza vaccine

Criteria

Inclusion Criteria:

  • Have an active cell phone with text messaging capability
  • Presents for care at participating sites
  • Fluent in English or Spanish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233388

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Philip LaRussa, MD Columbia University
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
  More Information

No publications provided

Responsible Party: Melissa Stockwell, MD, MPH, Asst Prof of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01233388     History of Changes
Other Study ID Numbers: AAAD1619
Study First Received: October 29, 2010
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014