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Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through GP Clinics

Primary Purpose

Immunization Programs

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Immunization Programs focused on measuring Influenza Vaccines, Pneumococcal Vaccines, Primary Health Care, Health Communication, Cross-Over Studies, Randomized Controlled Trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients seen at GP clinics involved in our study AND
  • Aged 65 years and above, with or without chronic disease

Exclusion Criteria:

  • Patients not seen at GP clinics involved in our study
  • Patients aged below 65 years old

Sites / Locations

  • Frontier Healthcare Group
  • OneCare Medical Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Clinics assigned to the intervention arm will receive an educational intervention. This comprises posters on vaccination to be put up in the clinic, as well as a flyer which will be handed out by the clinic assistants to all patients 65 years and above, at the point of registration. The poster and flyer content will provide simple messaging to encourage patients to receive influenza and pneumococcal vaccinations and inform them of available healthcare subsidies.

Clinics assigned to control arm will run as per their normal operations and not have the interventions implemented.

Outcomes

Primary Outcome Measures

Difference in influenza vaccination uptake rate for clinics between intervention and non-intervention periods
The proportion of all eligible patients arriving at each clinic who receive influenza vaccine during the intervention period compared to the non-intervention period for each clinic.
Difference in pneumococcal vaccination uptake rate for clinics between intervention and non-intervention periods
The proportion of all eligible patients arriving at each clinic who receive pneumococcal vaccine during the intervention period compared to the non-intervention period for each clinic.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2018
Last Updated
July 1, 2019
Sponsor
Tan Tock Seng Hospital
Collaborators
Frontier Healthcare Group, OneCare Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT03445117
Brief Title
Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through GP Clinics
Official Title
Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through General Practitioner Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Frontier Healthcare Group, OneCare Medical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pneumonia and influenza are among the top causes of hospitalisation and death in the elderly. While vaccinations are recommended against these diseases, a large proportion of elderly in the community remain unvaccinated, with approximately only 10% vaccinated for either disease. In this study, the investigators aim to implement an intervention package within GP clinics to increase influenza and pneumococcal vaccination rates, especially among elderly patients with chronic diseases.
Detailed Description
Influenza and pneumococcal disease contribute considerably to hospitalisation and mortality in the elderly. While recommended vaccines can reduce disease burden, vaccine uptake remains very low in Singapore, with approximately only 10% of elderly appropriately vaccinated for either disease. Improving vaccine uptake rates could be effected through private sector primary care clinics, which are highly accessible in Singapore. An intervention bundle we piloted in one clinic comprised physician reminders and patient-targeted posters and brochures. Influenza and pneumococcal vaccine rates both increased by >30% over the baseline, although half of eligible patients remained unvaccinated. There is thus scope to devise a more effective intervention bundle and demonstrate its efficacy through a more robust and generalisable study design. This study aims to evaluate the efficacy of an intervention bundle deployed in general practice clinics to promote influenza and pneumococcal vaccine uptake among elderly patients. The intervention bundle components include educational materials such as posters and flyers, which also serve as reminder slips for attending physicians. The intervention will be implemented in a two-arm cluster randomised crossover trial in up to 30 primary care clinics. Control arm clinics will receive no interventions. Clinics will be randomised into either of the two arms for a period of 3 months, followed by a washout of 1 month before a crossover is performed. The investigators will subsequently compare vaccination rates during intervention and control periods to provide evidence for effectiveness of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunization Programs
Keywords
Influenza Vaccines, Pneumococcal Vaccines, Primary Health Care, Health Communication, Cross-Over Studies, Randomized Controlled Trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
two-arm cluster randomised crossover trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8837 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clinics assigned to the intervention arm will receive an educational intervention. This comprises posters on vaccination to be put up in the clinic, as well as a flyer which will be handed out by the clinic assistants to all patients 65 years and above, at the point of registration. The poster and flyer content will provide simple messaging to encourage patients to receive influenza and pneumococcal vaccinations and inform them of available healthcare subsidies.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Clinics assigned to control arm will run as per their normal operations and not have the interventions implemented.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
a) The educational intervention comprises putting up posters on vaccination in the clinic, as well as provision of a specially designed flyer to the clinic, which will be handed out by the clinic assistants to all patients 65 years and above, at the point of registration. The poster and flyer content will provide simple messaging to encourage patients to receive influenza and pneumococcal vaccinations and inform them of available healthcare subsidies. b) Reminders to physicians: The flyers will also serve as physical prompts to physicians to encourage vaccination for their patients. Doctors and clinic staff will also be updated on the study protocol and the recommended adult vaccination schedule before commencement of the study.
Primary Outcome Measure Information:
Title
Difference in influenza vaccination uptake rate for clinics between intervention and non-intervention periods
Description
The proportion of all eligible patients arriving at each clinic who receive influenza vaccine during the intervention period compared to the non-intervention period for each clinic.
Time Frame
8 months (post-study completion)
Title
Difference in pneumococcal vaccination uptake rate for clinics between intervention and non-intervention periods
Description
The proportion of all eligible patients arriving at each clinic who receive pneumococcal vaccine during the intervention period compared to the non-intervention period for each clinic.
Time Frame
8 months (post-study completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients seen at GP clinics involved in our study AND Aged 65 years and above, with or without chronic disease Exclusion Criteria: Patients not seen at GP clinics involved in our study Patients aged below 65 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Hanley Ho
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frontier Healthcare Group
City
Singapore
ZIP/Postal Code
400305
Country
Singapore
Facility Name
OneCare Medical Group
City
Singapore
ZIP/Postal Code
609966
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31622142
Citation
Ho HJ, Tan YR, Cook AR, Koh G, Tham TY, Anwar E, Hui Chiang GS, Lwin MO, Chen MI. Increasing Influenza and Pneumococcal Vaccination Uptake in Seniors Using Point-of-Care Informational Interventions in Primary Care in Singapore: A Pragmatic, Cluster-Randomized Crossover Trial. Am J Public Health. 2019 Dec;109(12):1776-1783. doi: 10.2105/AJPH.2019.305328. Epub 2019 Oct 17.
Results Reference
derived

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Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through GP Clinics

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