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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03445117
Other study ID # DSRB 2017/00441
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date July 31, 2018

Study information

Verified date June 2019
Source Tan Tock Seng Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8837
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Singapore Frontier Healthcare Group Singapore
Singapore OneCare Medical Group Singapore

Sponsors (3)

Lead Sponsor Collaborator
Tan Tock Seng Hospital Frontier Healthcare Group, OneCare Medical Group

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 months (post-study completion)
Primary 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. 8 months (post-study completion)
See also
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