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

• ClinicalTrials.gov Identifier: NCT03445117
• Recruitment Status: Completed
• First Posted: February 26, 2018
• Last Update Posted: July 5, 2019
• Sponsor: Tan Tock Seng Hospital
• Collaborators: Frontier Healthcare Group; OneCare Medical Group
• Information provided by (Responsible Party): Tan Tock Seng Hospital

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.

Condition or disease	Intervention/treatment	Phase
Immunization Programs	Other: Educational intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8837 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: two-arm cluster randomised crossover trial
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through General Practitioner Clinics
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: July 31, 2018
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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.	Other: Educational intervention; 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.
No Intervention: Control; Clinics assigned to control arm will run as per their normal operations and not have the interventions implemented.

Outcome Measures

Primary Outcome Measures :

1. Difference in influenza vaccination uptake rate for clinics between intervention and non-intervention periods [ Time Frame: 8 months (post-study completion) ]
   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.
2. Difference in pneumococcal vaccination uptake rate for clinics between intervention and non-intervention periods [ Time Frame: 8 months (post-study completion) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Singapore

Frontier Healthcare Group

Singapore, Singapore, 400305

OneCare Medical Group

Singapore, Singapore, 609966

Sponsors and Collaborators

Tan Tock Seng Hospital

Frontier Healthcare Group

OneCare Medical Group

Investigators

• Principal Investigator: Dr Hanley Ho; Tan Tock Seng Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Tan Tock Seng Hospital
• ClinicalTrials.gov Identifier: NCT03445117
• Other Study ID Numbers: DSRB 2017/00441
• First Posted: February 26, 2018
• Last Update Posted: July 5, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tan Tock Seng Hospital:

Influenza Vaccines; Pneumococcal Vaccines; Primary Health Care; Health Communication; Cross-Over Studies; Randomized Controlled Trial

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases