Immunization ProgramsNCT03445117
Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through GP Clinics
A study testing Educational intervention in people with Immunization Programs, run by Tan Tock Seng Hospital at 2 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Immunization Programs
- What is being tested?
- Educational intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,837 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Nov 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients seen at GP clinics involved in our study AND
- Aged 65 years and above, with or without chronic disease
Who cannot join
- Patients not seen at GP clinics involved in our study
- Patients aged below 65 years old
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Frontier Healthcare Group
Singapore, 400305
OneCare Medical Group
Singapore, 609966
About this study
Official title: Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through General Practitioner Clinics
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.
Read the 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.
- Conditions
- Immunization Programs
- Being tested
- Educational intervention
- Keywords
- Influenza Vaccines, Pneumococcal Vaccines, Primary Health Care, Health Communication, Cross-Over Studies, Randomized Controlled Trial
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Educational intervention |
| Control | No intervention | Clinics assigned to control arm will run as per their normal operations and not have the interventions implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months (post-study completion)
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.
Measured: 8 months (post-study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunization ProgramsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-arm cluster randomised crossover trial
- Masking
- None (open label)
- Enrolment
- 8,837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Healthcare Group, OneCare Medical Group
- Responsible party
- Sponsor
- Investigators
- Dr Hanley Ho, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445117
- Sponsor's protocol ID
- DSRB 2017/00441
- Status last verified
- Jun 2019
- First submitted
- 28 Jan 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31622142
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through General Practitioner Clinics
- ClinicalTrials.gov ID
- NCT03445117
- Acronym / sponsor ID
- DSRB 2017/00441
- Conditions
- Immunization Programs
- Keywords
- Influenza Vaccines, Pneumococcal Vaccines, Primary Health Care, Health Communication, Cross-Over Studies, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,837 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Frontier Healthcare Group, OneCare Medical Group
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-arm cluster randomised crossover trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Educational interventionClinics 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. |
| Control | No intervention | –Clinics assigned to control arm will run as per their normal operations and not have the interventions implemented. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients seen at GP clinics involved in our study AND
- Aged 65 years and above, with or without chronic disease
Key exclusion criteria (2 listed)
- Patients not seen at GP clinics involved in our study
- Patients aged below 65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventiona) 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. | Other | Intervention |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 31622142Ho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Hanley Ho principal investigator
Tan Tock Seng Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Immunization Programs, run by Tan Tock Seng Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in influenza vaccination uptake rate for clinics between intervention and non-intervention periods (time frame: 8 months (post-study completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.