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Behavioural Science Interventions to Improve Health EquityNCT06163222

Behavioural Interventions to Improve Equity in Outpatient Access

A study testing Additional message with behavioural science-informed content and associated web pages and Usual communication strategy in people with Behavioural Science Interventions to Improve Health Equity, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to improve health equity within outpatient service access. This is through design and behavioural science-informed interventions that aim to improve rates of first outpatient appointment attendance. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Additional message with behavioural science-informed content and associated web pages and Usual communication strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13,389 participants
Where
1 siteUnited Kingdom
Study dates
8 Jan 2024to 20 Nov 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients who have been referred to their first outpatient appointment at one of five ICHT adult clinical specialties - Cardiology, Colorectal Surgery, Gastroenterology, Ophthalmology and Plastic Surgery.

Who cannot join

  • Phone or video appointments
  • Diagnostics appointments
  • Two-week wait appointments
  • Saturday or Sunday appointments
  • Appointments without message reminders switched on in DrDoctor
  • Patients who re-enter the study and receive >1 intervention
  • Patients who received email message reminders about their appointment (until 23rd May 2024, after which they will be included due to change in ICHT communications approach)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Imperial College Healthcare NHS Trust

    London

Other trials in United Kingdom

About this study

Official title: Can User-centred Design and Behavioural-science Informed Interventions Improve Equity in Outpatient Access in North West London? A Non-randomised Controlled Trial

The goal of this clinical trial is to improve health equity within outpatient service access. This is through design and behavioural science-informed interventions that aim to improve rates of first outpatient appointment attendance. Health equity refers to the avoidable and unfair differences in health access, outcomes and experience between groups or populations. Outpatient services are those appointments where advice from a specialised medical professional is provided to a patient in a clinic setting.

This clinical trial aims to test different ways of supporting people to attend their first outpatient appointments at five clinical specialties (ophthalmology, gastroenterology, colorectal surgery, cardiology and plastic surgery) at Imperial College Healthcare NHS Trust (ICHT). It is specifically focused on improving attendance for people who are most likely to miss their appointment based on ICHT data, which includes people from minority ethnic backgrounds and people living in the most deprived postcodes.

Read more

The main question this clinical trial aims to answer is:

  • Do behavioural science-informed message interventions improve rates of first outpatient appointment attendance in patients facing inequity of access based on ethnicity and deprivation?

The secondary questions this clinical trial aims to answer include:

  • Do behavioural science-informed message interventions improve rates of first outpatient appointment attendance across all patient groups?
  • Do behavioural science-informed message interventions increase the number of patients who "self-cancel" their appointment if they need to?
  • In which patient groups did the message interventions have most impact, e.g., a certain age range?
  • Which factors were associated with improved outpatient attendance rates specifically in participants from minority ethnic groups or living in area with highest level of deprivation?
  • What was the overall outcome of all first outpatient appointments included in the clinical trial?
  • What was the overall successful message delivery rate for the messages sent as part of the study? Were there particular participant groups that were more likely to have an undelivered message?
  • What was the overall outcome of appointment attendance for people who received a text message intervention compared with receiving a text message and/or email intervention?
  • How well did participants engage with the message interventions e.g. did they click the link provided in the message?
Read the detailed description

This clinical trial has been designed as a non-randomised controlled trial, aiming to test the impact of three design and behavioural science-informed interventions on first outpatient appointment attendance in groups at highest risk of inequity. The interventions will be tested in five clinical specialties at ICHT - cardiology, gastroenterology, ophthalmology, plastic surgery, and colorectal surgery. The study is estimated to last 48 weeks. The messages sent as part of the trial will be deployed by ICHT staff members who manage outpatient services.

Prior to conducting this trial, three message and web page interventions were co-designed with a diverse group of public members with good representation from the IMD and ethnicity groups facing inequity of access, ICHT staff, researchers, and behavioural science experts. These interventions were based on insights on barriers to appointment attendance gained from short qualitative interviews conducted with people who had missed appointments at ICHT and who also faced inequity based on ethnicity or deprivation.

This study has been designed to have four arms. These four arms will include a control arm, that will be the standard practice communication strategy used by each clinical specialty, as well as three intervention strategies. Currently the standard communications that patients receive before an outpatient appointment varies, but commonly patients receive a reminder 3 and 7 days before the appointment at ICHT. The three co-designed interventions for the trial are all based on an additional message reminder to this existing reminder schedule that will be sent to patients 14 days before their appointment. DrDoctor is the message provider that is currently used by ICHT and that the interventions will be housed in. The web pages will be housed in the existing ICHT website. All five clinical specialties will spend one week in each study arm, before cycling to the next arm. They will move from one arm to the next, until they return to their original study arm, resulting in continuous four-week cycles until the final study period is reached. Therefore, the five clinical specialties will all be in the same study arms at the same time and go through the cycle together until the sample size is reached. This method of allocation of clinics to study arms has been selected as it is not possible with the current technology being used at ICHT to randomise participants within clinics to different study arms.

Data will be collected on the message delivery and appointment outcomes throughout the trial and full analysis will take place at the end of the trial, once the sample size has been reached. The rate of missed appointments will be monitored throughout the study to assess if there is any backfire effect of the interventions.

For the first approximately 20 weeks of the study, only participants who received the intervention as a text message will be analysed. However after this point, as email notifications were turned on by ICHT for all patients, both text and/or email interventions will be analysed.

Being tested
Additional message with behavioural science-informed content and associated web pages, Usual communication strategy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional message with behavioural science-informed content and associated web pagesBehavioural

    Behavioural science-informed messages sent 14-days prior to outpatient appointment which include links to re-designed web pages

  • Usual communication strategyOther

    Usual communications sent from outpatient services to remind participants about their appointments

Study groups in NCT06163222
Study groupRoleWhat they receive
Getting to your appointmentExperimentalAdditional 14-day message reminder that includes link to new transport index web page
Receives: Behavioral: Additional message with behavioural science-informed content and associated web pages
Help with travel costsExperimentalAdditional 14-day message reminder that includes link to new 'help with travel costs' web page
Receives: Behavioral: Additional message with behavioural science-informed content and associated web pages
What to expectExperimentalAdditional 14-day message reminder that includes link to 'what to expect' web page
Receives: Behavioral: Additional message with behavioural science-informed content and associated web pages
Usual communicationsActive comparatorExisting communication strategy used for each of the five clinical specialties e.g. reminder messages 3 and 7 days prior to outpatient appointment
Receives: Other: Usual communication strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Did Not Attend (DNA) rate for first outpatient appointment across five clinical specialties with an emphasis on participants' ethnicity and the deprivation level of their address (Index of Multiple Deprivation quintiles)

    Did Not Attend (DNA) rate is the change over time in the number of people who do not attend their outpatient appointment without cancelling or rescheduling. This rate will be analysed for the clinics included in the study and to see if it changes over time with our interventions.

    While this change in DNA rate over time will be analysed for all patients, the research team will focus particularly on how this changes with a patient's ethnicity and the deprivation of where they live. Deprivation is currently recorded by ICHT using the Index of Multiple Deprivation (IMD) which assigns a score to a patient's postcode to indicate its level of deprivation based on multiple factors.

    Measured: End of study period (12 months)

Secondary outcomes (8)
  1. Change in DNA rate at first outpatient appointment across all five clinical specialties for all participant groups

    Did Not Attend (DNA) rate is the change over time in the number of people who do not attend their outpatient appointment without cancelling or rescheduling. This rate will be analysed for the clinics included in the study and to see if it changes over time with our interventions.

    While the primary outcome focuses on ethnicity and deprivation, this outcome will focus on describing any other changes in DNA rate seen across all patient groups.

    Measured: End of study period (12 months)

  2. Change in Patient-Initiated Cancellation (PIC) rate for first outpatient appointment across all five clinical specialties.

    Patient-Initiated Cancellation (PIC) rate is the change over time in the number of people who cancel their outpatient appointment ahead of time. This rate will be analysed for the clinics included in the study and to see if it changes over time with our interventions.

    Measured: End of study period (12 months)

  3. Change in DNA rate at first outpatient appointment across all five clinical specialties for population subgroups, controlling for variables such as ethnicity, participant demographics, clinic specialty and IMD

    Did Not Attend (DNA) rate is the change over time in the number of people who do not attend their outpatient appointment without cancelling or rescheduling.

    This will provide an evaluation of where the selected interventions had most impact according to patient characteristics. Focus will be given to analysing in more detail patients of 'Black', 'mixed' or 'other' ethnicity as well as those living in areas with the greatest level of deprivation (IMD quintile 1) to further understand what variables are associated with a decrease in DNA rates in these populations specifically.

    Measured: End of study period (12 months)

  4. Change in the rate of appointment outcomes (attended, DNA, PIC, Hospital-Initiated Cancellation) for first outpatient appointments across all five clinical specialties

    Analysis will be carried out to understand what the outcomes of all appointments included in the study and how this changes from the start of the study. For example, the outcomes could be that the patient attended the appointment, missed the appointment, cancelled the appointment in advance or the hospital cancelled the appointment.

    Measured: End of study period (12 months)

  5. Differences between message delivery rate for study interventions across all five clinical specialties for different population subgroups

    The study team will analyse the message delivery rate for the study interventions. This refers to the number of messages that were successfully delivered to study participants. This will be analysed to see if unsuccessful message delivery rates are associated with specific population subgroups e.g. patients living in more deprived areas.

    Measured: End of study period (12 months)

  6. Differences between each study intervention's click-through rate from message to web page for all participant groups

    The click-through rate for the study interventions will be analysed as part of the study, which describes the proportion of people who click the link provided in the messages as part of the study to view the associated web page. The different interventions will be compared to see which had higher click-through rates over time.

    Measured: End of study period (12 months)

  7. Differences between each study intervention's web page engagement using Google Analytics for each of the study interventions for all participant groups

    The Google Analytics report for the ICHT web pages developed as part of the study will be analysed to understand which parts of the pages that people engaged with most and how they interacted with the site, a tool and practice that is currently already used at ICHT. The different web pages reports will be compared with each other to review their engagement over time.

    Measured: End of study period (12 months)

  8. Change in the rate of appointment outcomes (attended, DNA, PIC, Hospital-Initiated Cancellation) for appointments that received text message-only and appointments that received text and/or email interventions

    For the first approximately 20 weeks of the study, data will be analysed for appointments that received text message-only interventions. This is because only a small number of patients had opted into email reminders, so these patients were going to be removed for analysis. However, ICHT turned on automatic email notifications for all patients during the study, and after this stage both text message and email reminders will be analysed. The study team will analyse appointment attendance between people who received just the text message interventions compared with people who received text and email interventions, once ICHT had turned on email reminders.

    Measured: End of study period (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start8 Jan 2024
  3. Primary completion20 Nov 2024
  4. Study completion20 Nov 2024

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13,389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06163222
Sponsor's protocol ID
23IC8361
Status last verified
Apr 2025
First submitted
21 Nov 2023
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared with other researchers.

Publications

  • Huf S, Kerrison RS, King D, Chadborn T, Richmond A, Cunningham D, Friedman E, Shukla H, Tseng FM, Judah G, Darzi A, Vlaev I. Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials. Prev Med. 2020 Oct;139:106170. doi: 10.1016/j.ypmed.2020.106170. Epub 2020 Jun 29.

    PubMed 32610059
  • Acharya A, Ashrafian H, Cunningham D, Ruwende J, Darzi A, Judah G. Evaluating the impact of a novel behavioural science informed animation upon breast cancer screening uptake: protocol for a randomised controlled trial. BMC Public Health. 2022 Jul 19;22(1):1388. doi: 10.1186/s12889-022-13781-x.

    PubMed 35854267
  • Hallsworth M, Berry D, Sanders M, Sallis A, King D, Vlaev I, Darzi A. Stating Appointment Costs in SMS Reminders Reduces Missed Hospital Appointments: Findings from Two Randomised Controlled Trials. PLoS One. 2015 Sep 14;10(9):e0137306. doi: 10.1371/journal.pone.0137306. eCollection 2015.

    PubMed 26366885

Questions about this trial

What is this clinical trial studying?

A study testing Additional message with behavioural science-informed content and associated web pages and Usual communication strategy in people with Behavioural Science Interventions to Improve Health Equity, run by Imperial College London at 1 site in United Kingdom.

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 7 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Change in Did Not Attend (DNA) rate for first outpatient appointment across five clinical specialties with an emphasis on participants' ethnicity and the deprivation level of their address (Index of Multiple Deprivation quintiles) (time frame: End of study period (12 months)). 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 NCT06163222, which also lists 3 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 9 Apr 2025.

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