SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM (SOP)
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| ClinicalTrials.gov Identifier: NCT01868334 |
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Recruitment Status :
Completed
First Posted : June 4, 2013
Results First Posted : October 2, 2017
Last Update Posted : November 30, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult Influenza Vaccinations Adult PPSV Vaccinations Adult Tdap/Td Vaccinations | Behavioral: Pillar 1: Convenient Vaccination Services Behavioral: Pillar 2: Patient notification Behavioral: Pillar 3: Enhanced Office Systems Behavioral: Pillar 4: Motivation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70549 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM |
| Study Start Date : | April 2013 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention with the Toolkit
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. |
Behavioral: Pillar 1: Convenient Vaccination Services
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. Behavioral: Pillar 2: Patient notification 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 Behavioral: Pillar 3: Enhanced Office Systems 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 Behavioral: Pillar 4: Motivation 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. |
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No Intervention: 12 clinical practices (control sites)
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
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- Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 [ Time Frame: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza) ]Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1
- Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 [ Time Frame: % vaccinated by 1/31/2015 ]Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868334
| United States, Pennsylvania | |
| University of Pittsburgh, School of Medicine, Department of Family Medicine | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Baylor Colllege of Medicine | |
| Houston, Texas, United States, 77030 | |
| Study Director: | Mary Patricia Nowalk, PhD, RD | University of Pittsburgh, School of Medicine, Department of Family Medicine | |
| Study Director: | Anthony E Brown, MD MPH | Baylor College of Medicine |
| Responsible Party: | Richard Zimmerman, Principal Investigator, Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01868334 |
| Other Study ID Numbers: |
CDC-1U01IP000662-01 |
| First Posted: | June 4, 2013 Key Record Dates |
| Results First Posted: | October 2, 2017 |
| Last Update Posted: | November 30, 2017 |
| Last Verified: | October 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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influenza vaccine PPSV Tdap vaccination adult |
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Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |