DiabetesIDEASNCT02339909
Incentives in Diabetic Eye Assessment by Screening
A study testing Fixed financial incentive and Probabilistic financial incentive in people with Diabetes and Diabetic Retinopathy, run by Imperial College London.
Trial summary
This trial is a randomised controlled trial to assess whether annual attendance rates at diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved by offering invitees a small financial incentive. The research questions are: 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes, Diabetic Retinopathy
- What is being tested?
- Fixed financial incentive and Probabilistic financial incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,051 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients who were invited to screening in the last 24 months on a yearly basis and failed to attend or contact the screening service to rearrange an appointment
Who cannot join
- -
About this study
Official title: Incentives in Diabetic Eye Assessment by Screening (IDEAS) Trial
This trial is a randomised controlled trial to assess whether annual attendance rates at diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved by offering invitees a small financial incentive. The research questions are:
- Are incentives an effective strategy to encourage participation in the screening programme?
- Does the design of the financial incentive scheme affect its effectiveness in influencing participation in health screening?
- Does the choice of incentive scheme, if successful, attract patients who have a different demographic or socioeconomic status to those who attend screening regularly?
- Is offering these incentives a cost-effective strategy for enhancing participation?
Read the detailed description
An increasing emphasis is being placed on preventative healthcare in the NHS (National Health Service). Screening programmes currently exist in many clinical areas including diabetic retinopathy as well as breast cancer, cervical cancer and cardiovascular disease. In many contexts the benefits of health screening are well documented, but concerns exist about the effectiveness and cost-effectiveness of such programmes as uptake to screening may be very poor in some, generally hard to reach, communities. There are many ways of trying to encourage participation in health promoting activities and it is likely real shifts in behaviour will only come about with a mix of strategies. In this study we set out to see if we can improve screening rates in London, which has both high and low levels of deprivation and specific populations with poor attendance. The ultimate success of a high-quality screening program depends on the uptake rate of the population and novel solutions are required to meet the challenge of achieving this.
Diabetes is an increasing public health concern worldwide. There are 2.9 million people diagnosed with diabetes in the UK (United Kingdom) and an estimated 850,000 people who have the condition but are not recognised. Whilst the rates of other vascular risk factors such as hypertension, smoking and hypercholesterolaemia are falling, the rates of diabetes in the UK are rising. This is despite the co-ordinated efforts of primary and secondary care prevention programmes.
All patients with diabetes are at risk of developing diabetic retinopathy. This condition is caused by the microscopic damage to small blood vessels to the eye. There is proliferation (growth) of these vessels and these new fragile vessels may bleed and destroy the retina leading to sight loss. It is estimated that in England every year 4,200 people are at risk of blindness caused by diabetic retinopathy and there are 1,280 new cases of blindness caused by diabetic retinopathy. It is the leading cause of sight loss in the UK in the working population and therefore there is a significant social and financial burden associated with the condition. However with timely diagnosis and treatment the risk of blindness can be dramatically reduced. As this condition may well remain silent until catastrophic late manifestations of the disease are evident, the need for an effective screening programme is obvious.
The National Screening programme was implemented in England between 2003 and 2006. This involves an annual retinal digital photographic screening offered to all people aged 12 years and older diagnosed with type 1 and type 2 diabetes. The test involves administration of eye drops to the eye and a photograph of the retina taken without contact with the eye. The success of this screening programme is without contest. In 2011-2012, 2,587,000 people in England aged 12 and over were identified with diabetes and over 90% were offered screening for diabetic retinopathy. 1,911,000 received screening which equates to an uptake of 81%. However there is significant variability in uptake in differing areas.
Although screening is offered in multiple locations including GP (general practice) surgeries and hospitals, the poor uptake of screening in socially deprived areas is well documented. For example, in Gloucestershire, with each increasing quintile of deprivation, diabetes prevalence increases (odds ratio 0.84), the probability of having been screened for diabetic retinopathy decreases (odds ratio 1.11), and the prevalence of sight-threatening diabetic retinopathy among screened patients increases also (odds ratio of 0.98).
Since the effectiveness of any screening programme is intimately linked to the uptake by the population (and in particular uptake by those most at risk), simple, inexpensive and cost effective strategies are required by the NHS to influence population health behaviours in domains where choices are often in sharp contrast to underlying intentions. This has relevance to diabetic retinopathy screening but also more widely as we increasingly try to prevent disease rather than simply treat it.
Incentives are central to economics and are used across the public and private sectors to influence behaviour. Psychological phenomena from behavioural economics allow us to design incentive-based interventions that are more effective at delivering improved outcomes. Personal incentives have been used to motivate patients and general populations to change their behaviour. Examples of behaviours targeted include smoking and drug use cessation. Incentives can include cash, vouchers or benefits-in-kind and they can have a profound effect on individual behaviour at a relatively small cost. Interest in offering incentives to foster healthier lifestyles has increased, as the full economic and social costs of bad choices and unhealthy behaviour have become apparent. Incentives have previously been used to improve cancer screening rates, but they have been targeted at the providers of the service rather than people invited to attend for screening. Financial incentives have been seen to be more effective in increasing performance of infrequent behaviours (e.g. vaccinations) rather than in more sustained behaviours (e.g. smoking). As screening usually requires discrete one-off behaviours, incentives may be particularly effective in increasing their uptake.
A wider use of incentives in public health interventions is a more recent phenomenon and has attracted controversy and concerns about whether they are effective (and cost effective) or not. This study will provide evidence to policy makers about the role of different incentive schemes in encouraging health promoting behaviours. We do not suggest that providing incentives is the only answer to encouraging screening participation, but if we demonstrate good evidence that they are effective (and cost effective), their targeted application may be indicated. Equally demonstration that incentives of this type are not effective may prevent unnecessary financial loss from the NHS if wider rollout of such programmes is considered.
- Conditions
- Diabetes, Diabetic Retinopathy
- Being tested
- Fixed financial incentive, Probabilistic financial incentive, Control
- Keywords
- Screening, Incentives
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed financial incentiveBehavioural
Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
Probabilistic financial incentiveBehavioural
Also called Lottery to financial incentive
Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
ControlBehavioural
Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.) Receives: Behavioral: Control |
| Fixed Incentive | Experimental | The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.) Receives: Behavioral: Fixed financial incentive |
| Probabilistic Incentive | Experimental | The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.) Receives: Behavioral: Probabilistic financial incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Attending Screening Appointment
The participants will be invited to a specific appointment between three months and one year from their previous missed appointment. The primary outcome refers to the number of participants who did attend their appointment.
Measured: At designated appointment date (between three months and one year from previous missed appointment)
Secondary outcomes (1)
Number of Patients Requiring Intervention After Sight Outcome From Diabetic Retinopathy Screening.
The outcome measure from screening is an ordinal measure indicating whether there is no retinopathy, or varying degrees of retinopathy. This will be measured at the screening appointment (for those participants who attend their appointment). We report whether there is further management required as a result of screening.
Measured: Number of patients with additional management triggered as a result of test at designated screening appointment (between three months and one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Colin Bicknell, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339909
- Sponsor's protocol ID
- REC 14/LO/1779
- Acronym
- IDEAS
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2014
- Last updated
- 19 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Scanlon PH, Carter SC, Foy C, Husband RF, Abbas J, Bachmann MO. Diabetic retinopathy and socioeconomic deprivation in Gloucestershire. J Med Screen. 2008;15(3):118-21. doi: 10.1258/jms.2008.008013.
PubMed 18927093Marteau TM, Ashcroft RE, Oliver A. Using financial incentives to achieve healthy behaviour. BMJ. 2009 Apr 9;338:b1415. doi: 10.1136/bmj.b1415. No abstract available.
PubMed 19359291
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives in Diabetic Eye Assessment by Screening (IDEAS) Trial
- ClinicalTrials.gov ID
- NCT02339909
- Acronym / sponsor ID
- IDEAS / REC 14/LO/1779
- Conditions
- Diabetes, Diabetic Retinopathy
- Keywords
- Screening, Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a randomised controlled trial to assess whether annual attendance rates at diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved by offering invitees a small financial incentive. The research questions are:
- Are incentives an effective strategy to encourage participation in the screening programme?
- Does the design of the financial incentive scheme affect its effectiveness in influencing participation in health screening?
- Does the choice of incentive scheme, if successful, attract patients who have a different demographic or socioeconomic status to those who attend screening regularly?
- Is offering these incentives a cost-effective strategy for enhancing participation?
Detailed description
An increasing emphasis is being placed on preventative healthcare in the NHS (National Health Service). Screening programmes currently exist in many clinical areas including diabetic retinopathy as well as breast cancer, cervical cancer and cardiovascular disease. In many contexts the benefits of health screening are well documented, but concerns exist about the effectiveness and cost-effectiveness of such programmes as uptake to screening may be very poor in some, generally hard to reach, communities. There are many ways of trying to encourage participation in health promoting activities and it is likely real shifts in behaviour will only come about with a mix of strategies. In this study we set out to see if we can improve screening rates in London, which has both high and low levels of deprivation and specific populations with poor attendance. The ultimate success of a high-quality screening program depends on the uptake rate of the population and novel solutions are required to meet the challenge of achieving this.
Diabetes is an increasing public health concern worldwide. There are 2.9 million people diagnosed with diabetes in the UK (United Kingdom) and an estimated 850,000 people who have the condition but are not recognised. Whilst the rates of other vascular risk factors such as hypertension, smoking and hypercholesterolaemia are falling, the rates of diabetes in the UK are rising. This is despite the co-ordinated efforts of primary and secondary care prevention programmes.
All patients with diabetes are at risk of developing diabetic retinopathy. This condition is caused by the microscopic damage to small blood vessels to the eye. There is proliferation (growth) of these vessels and these new fragile vessels may bleed and destroy the retina leading to sight loss. It is estimated that in England every year 4,200 people are at risk of blindness caused by diabetic retinopathy and there are 1,280 new cases of blindness caused by diabetic retinopathy. It is the leading cause of sight loss in the UK in the working population and therefore there is a significant social and financial burden associated with the condition. However with timely diagnosis and treatment the risk of blindness can be dramatically reduced. As this condition may well remain silent until catastrophic late manifestations of the disease are evident, the need for an effective screening programme is obvious.
The National Screening programme was implemented in England between 2003 and 2006. This involves an annual retinal digital photographic screening offered to all people aged 12 years and older diagnosed with type 1 and type 2 diabetes. The test involves administration of eye drops to the eye and a photograph of the retina taken without contact with the eye. The success of this screening programme is without contest. In 2011-2012, 2,587,000 people in England aged 12 and over were identified with diabetes and over 90% were offered screening for diabetic retinopathy. 1,911,000 received screening which equates to an uptake of 81%. However there is significant variability in uptake in differing areas.
Although screening is offered in multiple locations including GP (general practice) surgeries and hospitals, the poor uptake of screening in socially deprived areas is well documented. For example, in Gloucestershire, with each increasing quintile of deprivation, diabetes prevalence increases (odds ratio 0.84), the probability of having been screened for diabetic retinopathy decreases (odds ratio 1.11), and the prevalence of sight-threatening diabetic retinopathy among screened patients increases also (odds ratio of 0.98).
Since the effectiveness of any screening programme is intimately linked to the uptake by the population (and in particular uptake by those most at risk), simple, inexpensive and cost effective strategies are required by the NHS to influence population health behaviours in domains where choices are often in sharp contrast to underlying intentions. This has relevance to diabetic retinopathy screening but also more widely as we increasingly try to prevent disease rather than simply treat it.
Incentives are central to economics and are used across the public and private sectors to influence behaviour. Psychological phenomena from behavioural economics allow us to design incentive-based interventions that are more effective at delivering improved outcomes. Personal incentives have been used to motivate patients and general populations to change their behaviour. Examples of behaviours targeted include smoking and drug use cessation. Incentives can include cash, vouchers or benefits-in-kind and they can have a profound effect on individual behaviour at a relatively small cost. Interest in offering incentives to foster healthier lifestyles has increased, as the full economic and social costs of bad choices and unhealthy behaviour have become apparent. Incentives have previously been used to improve cancer screening rates, but they have been targeted at the providers of the service rather than people invited to attend for screening. Financial incentives have been seen to be more effective in increasing performance of infrequent behaviours (e.g. vaccinations) rather than in more sustained behaviours (e.g. smoking). As screening usually requires discrete one-off behaviours, incentives may be particularly effective in increasing their uptake.
A wider use of incentives in public health interventions is a more recent phenomenon and has attracted controversy and concerns about whether they are effective (and cost effective) or not. This study will provide evidence to policy makers about the role of different incentive schemes in encouraging health promoting behaviours. We do not suggest that providing incentives is the only answer to encouraging screening participation, but if we demonstrate good evidence that they are effective (and cost effective), their targeted application may be indicated. Equally demonstration that incentives of this type are not effective may prevent unnecessary financial loss from the NHS if wider rollout of such programmes is considered.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlThe intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.) |
| Fixed Incentive | Experimental | Behavioral: Fixed financial incentiveThe intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.) |
| Probabilistic Incentive | Experimental | Behavioral: Probabilistic financial incentiveThe intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients who were invited to screening in the last 24 months on a yearly basis and failed to attend or contact the screening service to rearrange an appointment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Fixed financial incentiveParticipants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment. | Behavioural | Fixed Incentive |
| Probabilistic financial incentiveAlso: Lottery to financial incentiveParticipants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment. | Behavioural | Probabilistic Incentive |
| ControlParticipants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter. | Behavioural | Control |
Primary outcome
Number of Patients Attending Screening Appointment
Time frame: At designated appointment date (between three months and one year from previous missed appointment)
The participants will be invited to a specific appointment between three months and one year from their previous missed appointment. The primary outcome refers to the number of participants who did attend their appointment.
1 secondary outcome
Number of Patients Requiring Intervention After Sight Outcome From Diabetic Retinopathy Screening.
Time frame: Number of patients with additional management triggered as a result of test at designated screening appointment (between three months and one year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18927093Scanlon PH, Carter SC, Foy C, Husband RF, Abbas J, Bachmann MO. Diabetic retinopathy and socioeconomic deprivation in Gloucestershire. J Med Screen. 2008;15(3):118-21. doi: 10.1258/jms.2008.008013.
- Background: PubMed 19359291Marteau TM, Ashcroft RE, Oliver A. Using financial incentives to achieve healthy behaviour. BMJ. 2009 Apr 9;338:b1415. doi: 10.1136/bmj.b1415. No abstract available.
- Diabetes UKLink provided by the sponsor.
- NHS diabetic eye screening websiteLink provided by the sponsor.
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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.
Colin Bicknell principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing Fixed financial incentive and Probabilistic financial incentive in people with Diabetes and Diabetic Retinopathy, run by Imperial College London.
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 1 inclusion and 1 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Attending Screening Appointment (time frame: At designated appointment date (between three months and one year from previous missed appointment)). 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 NCT02339909, which also lists 2 linked publications.
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 19 Oct 2023.