Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01519570
• Collaborator: (none)
• Enrollment: 2,589
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 286.6

Study Details

Study Description

Brief Summary

Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate the application of preventative health care, such as increasing immunization rates. A new care model that can increase the herpes zoster vaccination rate, as well as other preventative health services, is warranted. The objective of this study is to investigate if the functions of an EMR, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate.

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster Disease	Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2589 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Use of an Electronic Medical Record to Improve Standard Practice in the Primary Care Setting: A Randomized-Controlled Study of Herpes Zoster Vaccination Rates
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: An informational packet regarding shingles and the HZV	Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR; The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
No Intervention: Standard medical care from their primary care physician

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Received the Herpes Zoster Vaccine [6 months]

   Six months after the intervention, a second EMR report was generated to determine the change in vaccination rate of both the intervention and control groups.

Secondary Outcome Measures

1. Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email [6 months]

   Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)

2. Amount of Time Required by a Clinical Pharmacist to Manage This Workflow [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Greater than 60 years of age

Exclusion Criteria:

• Documented herpes zoster vaccine in the EMR

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Martha Morehouse General Internal Medicine Clinic	Columbus	Ohio	United States	43221

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Stuart J Beatty, PharmD, Ohio State University
• Study Chair: Shelley H Otsuka, PharmD, The Ohio State Univeristy
• Study Chair: Neeraj H Tayal, MD, Ohio State University
• Study Chair: Kyle Porter, MAS, Ohio State University
• Study Chair: Peter J Embi, MD, MS, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stuart Beatty, Assistant Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT01519570
• Other Study ID Numbers: 2010H0290
• First Posted: Jan 27, 2012
• Last Update Posted: Feb 1, 2019
• Last Verified: Aug 1, 2018

• Keywords provided by Stuart Beatty, Assistant Professor, Ohio State University: Herpes Zoster vaccine; Electronic patient portal; Electronic medical record; Primary care; Immunizations
• Additional relevant MeSH terms: Herpes Simplex; Herpes Zoster

Study Results

Participant Flow

Arm/Group Title	An Informational Packet Regarding Shingles and the HZV	Standard Medical Care From Their Primary Care Physician
Arm/Group Description	An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
Period Title: Overall Study
STARTED	500	2089
COMPLETED	500	2089
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	An Informational Packet Regarding Shingles and the HZV	Standard Medical Care From Their Primary Care Physician	Total
Arm/Group Description	An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.	Total of all reporting groups
Overall Participants	500	2089	2589
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	500 100%	2089 100%	2589 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.1 (9.4)	73.1 (8.1)	72.8 (8.7)
Sex: Female, Male (Count of Participants)
Female	265 53%	1174 56.2%	1439 55.6%
Male	235 47%	915 43.8%	1150 44.4%
Region of Enrollment (participants) [Number]
United States	500 100%	2089 100%	2589 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Received the Herpes Zoster Vaccine
Description	Six months after the intervention, a second EMR report was generated to determine the change in vaccination rate of both the intervention and control groups.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	An Informational Packet Regarding Shingles and the HZV	Standard Medical Care From Their Primary Care Physician
Arm/Group Description	An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
Measure Participants	500	2089
Count of Participants [Participants]	500 100%	2089 100%

2. Secondary Outcome

Title	Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email
Description	Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Amount of Time Required by a Clinical Pharmacist to Manage This Workflow
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	An Informational Packet Regarding Shingles and the HZV		Standard Medical Care From Their Primary Care Physician
Arm/Group Description	An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
All Cause Mortality
	An Informational Packet Regarding Shingles and the HZV		Standard Medical Care From Their Primary Care Physician
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	An Informational Packet Regarding Shingles and the HZV		Standard Medical Care From Their Primary Care Physician
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/500 (0%)		0/2089 (0%)
Other (Not Including Serious) Adverse Events
	An Informational Packet Regarding Shingles and the HZV		Standard Medical Care From Their Primary Care Physician
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/500 (0%)		0/2089 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.