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SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM (SOP)

Primary Purpose

Adult Influenza Vaccinations, Adult PPSV Vaccinations, Adult Tdap/Td Vaccinations

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pillar 1: Convenient Vaccination Services

Pillar 2: Patient notification

Pillar 3: Enhanced Office Systems

Pillar 4: Motivation

About this trial

This is an interventional health services research trial for Adult Influenza Vaccinations focused on measuring influenza vaccine, PPSV, Tdap, vaccination, adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Practice staff and adults in enrolled clinical sites

Inclusion Criteria:

Site inclusion criteria:

1) an appropriate adult population: e.g., adults aged 50 years and older;
2) currently using an EMR that has prompt ability, such as EpicCare;
3) having and keeping immunization data within this EMR

Patient-level inclusion criteria:

1) Adults (18 years and above) who are active patients of the enrolled practices (e.g., active patients are those with a visit within the last 12 months)
2) All unvaccinated adults without a contraindication are eligible to receive Td/Tdap and influenza, regardless of age and at age 65 years or older are eligible for PPSV.

Exclusion Criteria:

Site exclusion criteria:

1) consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%)

Patient-level exclusion criteria:

1) those with a true contraindication, following the CDC's Guide to Contraindications (attached with the US Recommended Adult Immunization Schedule), such as prior vaccine anaphylaxis.

Sites / Locations

University of Pittsburgh, School of Medicine, Department of Family Medicine
Baylor Colllege of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention with the Toolkit

12 clinical practices (control sites)

Arm Description

Pillar 1: Convenient Vaccination Services Pillar 2: Patient notification Pillar 3: Enhanced Office Systems Pillar 4: Motivation 13 clinical practices (intervention sites) will receive the Toolkit in Year 1 to increase their adult influenza, PPSV, Tdap/Td vaccination rates. In Year 2, those who choose to continue will "maintain" use of the Toolkit and online resources available but will receive no active intervention from study staff.

12 diverse clinical practices will receive no additional assistance in Year 1 to increase their adult influenza, PPSV, Tdap/Td vaccination rates, they will follow guidelines for usual care. In Year 2 however they will become intervention sites and receive the 4 Pillars Toolkit for use in increasing vaccination rates

Outcomes

Primary Outcome Measures

Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1

Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1

Secondary Outcome Measures

Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2

Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2

Full Information

NCT ID

NCT01868334

First Posted

March 20, 2013

Last Updated

October 4, 2023

Sponsor

University of Pittsburgh

Collaborators

Centers for Disease Control and Prevention, Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01868334

Brief Title

SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

Acronym

SOP

Official Title

A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Centers for Disease Control and Prevention, Baylor College of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and acellular pertussis vaccine (Tdap/Td) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practice with electronic medical records (EMRs).

Detailed Description

This intervention is a two-region, two-year, stratified randomized cluster trial in 24 primary care practices with EMRs. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; one set of practices randomized to intervention in year 1 and the other to control. In year 2, the other set of practices will receive the intervention and community controls may be sought. These diverse practices consist of: 18 diverse practices from UPMC in western Pennsylvania and 6 diverse practices from large community health centers in a PBRN in Texas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Influenza Vaccinations, Adult PPSV Vaccinations, Adult Tdap/Td Vaccinations

Keywords

influenza vaccine, PPSV, Tdap, vaccination, adult

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70549 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention with the Toolkit

Arm Type

Experimental

Arm Description

Arm Title

12 clinical practices (control sites)

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Pillar 1: Convenient Vaccination Services

Intervention Description

Extend Vaccination Season: Begin vaccinating for influenza as soon as vaccine arrives; use every visit as opportunity to vaccinate; extend the season for influenza by vaccinating in January and beyond. Use Express Vaccination services such as influenza vaccination clinics, Open access vaccine scheduling (for all vaccines), or dedicated vaccination station. When giving influenza vaccination, screen for need for PPSV/Tdap.

Intervention Type

Behavioral

Intervention Name(s)

Pillar 2: Patient notification

Intervention Description

Patient Education: notifying patients of doctor recommendations for vaccination; providing information on express vaccination services via email, autodialer, "on-hold" messages, clinic websites, and/or social media

Intervention Type

Behavioral

Intervention Name(s)

Pillar 3: Enhanced Office Systems

Intervention Description

Routine assessment for office systems flow to ensure staff consistently promoting vaccination: utilization of EMR prompts, review of Immunization tabs within EMR, and/or checking vaccination status as part of vital signs when rooming. Empower staff to vaccinate by use of a standing orders program (SOP). Order a sufficient supply of vaccination to cover increased rates

Intervention Type

Behavioral

Intervention Name(s)

Pillar 4: Motivation

Intervention Description

Utilization of an Office Immunization Champion who will track overall progress towards their goal - setting a goal of increased rates of 20 to 25% for influenza vaccine; monitoring and sharing progress with staff regularly; and changing office systems flow as needed to increased vaccination rates.

Primary Outcome Measure Information:

Title

Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1

Description

Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1

Time Frame

% vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)

Secondary Outcome Measure Information:

Title

Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2

Description

Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2

Time Frame

% vaccinated by 1/31/2015

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Practice staff and adults in enrolled clinical sites Inclusion Criteria: Site inclusion criteria: 1) an appropriate adult population: e.g., adults aged 50 years and older; 2) currently using an EMR that has prompt ability, such as EpicCare; 3) having and keeping immunization data within this EMR Patient-level inclusion criteria: 1) Adults (18 years and above) who are active patients of the enrolled practices (e.g., active patients are those with a visit within the last 12 months) 2) All unvaccinated adults without a contraindication are eligible to receive Td/Tdap and influenza, regardless of age and at age 65 years or older are eligible for PPSV. Exclusion Criteria: Site exclusion criteria: 1) consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%) Patient-level exclusion criteria: 1) those with a true contraindication, following the CDC's Guide to Contraindications (attached with the US Recommended Adult Immunization Schedule), such as prior vaccine anaphylaxis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Patricia Nowalk, PhD, RD

Organizational Affiliation

University of Pittsburgh, School of Medicine, Department of Family Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anthony E Brown, MD MPH

Organizational Affiliation

Baylor College of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

University of Pittsburgh, School of Medicine, Department of Family Medicine

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Baylor Colllege of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27809793

Citation

Lin CJ, Nowalk MP, Pavlik VN, Brown AE, Zhang S, Raviotta JM, Moehling KK, Hawk M, Ricci EM, Middleton DB, Patel S, South-Paul JE, Zimmerman RK. Using the 4 pillars practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial. BMC Infect Dis. 2016 Nov 3;16(1):623. doi: 10.1186/s12879-016-1940-1.

Results Reference

result

PubMed Identifier

27755655

Citation

Zimmerman RK, Brown AE, Pavlik VN, Moehling KK, Raviotta JM, Lin CJ, Zhang S, Hawk M, Kyle S, Patel S, Ahmed F, Nowalk MP. Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial. J Am Geriatr Soc. 2017 Jan;65(1):114-122. doi: 10.1111/jgs.14451. Epub 2016 Oct 18.

Results Reference

result

PubMed Identifier

27576073

Citation

Nowalk MP, Lin CJ, Pavlik VN, Brown AE, Zhang S, Moehling KK, Raviotta JM, South-Paul JE, Hawk M, Ricci EM, Middleton DB, Patel SA, Ahmed F, Zimmerman RK. Using the 4 Pillars Practice Transformation Program to increase adult Tdap immunization in a randomized controlled cluster trial. Vaccine. 2016 Sep 22;34(41):5026-5033. doi: 10.1016/j.vaccine.2016.07.053. Epub 2016 Aug 26.

Results Reference

result

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SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

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