Type1 DiabetesONSETNCT04002557
Optimising Consultation Summaries to Promote Good Health
An observational study of Type1 Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- Interview-Questionnaire
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2019to 31 Aug 2019
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- Child, Adult
Study population: Young people aged 12-18 years attending a single diabetes outpatient clinic were invited to enrol. This clinic served patients from a wide geographical area across London and the South-East England with broad socio-economic status, diabetes control and ethnicity.
Who may be able to join
- Adolescents aged 12-18 years attending UCLH adolescent diabetes outpatient clinic
Who cannot join
- Young people who cannot speak English (effective communication with colleagues during the study is the major aspect of valid data collection)
- Young people who refuse to participate in focus group discussions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2BU
About this study
Official title: Optimising Consultation Summaries to Promote Good Health/Views of Adolescents Attending Diabetes Clinic
Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding.
Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.
This research aims explore the views of adolescent patients related to consultation summaries that they receive following a doctor's appointment. The investigator will use patients attending a specialist diabetes clinic as our cohort and conduct a qualitative study using focus groups.
Read the detailed description
Patient participation in decision making processes about their care promotes patient satisfaction and confidence. As part of this, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Given this, the 2000 NHS plan made it a requirement that all medical correspondence between health professionals is shared with patients.
It is estimated that 40-80% of information discussed during a consultation is forgotten immediately. Written summaries have shown to be an effective method of improving patient recall of information by 20.8%.
The literature on the benefits/disadvantages of consultation summaries is largely focused on adult patients with little research done to explore the views of adolescent population. Where the patient is a child, the literature is only focussed on parents of children and not the children themselves. Limited research has shown that parents/care givers report clinic letters being useful in assisting with better understanding and management of their child's condition.
Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.
Adolescence is an important time of an individual's life. This is the time when many independent health behaviours are established. During adolescence, young people start showing more interest in their own health and often wish to participate in decision making processes regarding their care. The role of health workers at this stage is to appreciate young people as individuals . Clinic summaries addressed directly to young people might play an important role in assisting with establishment of health behaviours and promoting good health in young people.
The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.
- Conditions
- Type1 Diabetes
- Being tested
- Interview-Questionnaire
- Keywords
- diabetes, clinic letter, clinic summary, post-consultation letter
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview-QuestionnaireOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Focus group | This is a qualitative study using focus group discussions with young people aged 12-18 who are receiving consultation summaries.
Patients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.
Interviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant. Receives: Other: Interview-Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Completed Interviews About Consultation Summaries They Were Receiving
The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start31 May 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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 (8)Papers the sponsor has linked to this study.
- Other trials for Type1 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Inwald, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002557
- Sponsor's protocol ID
- 18IC4465
- Acronym
- ONSET
- Status last verified
- Apr 2024
- First submitted
- 17 Jun 2019
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bartle DG, Diskin L, Finlay F. Copies of clinic letters to the family. Arch Dis Child. 2004 Nov;89(11):1032-3. doi: 10.1136/adc.2004.051938.
PubMed 15499057Baxter S, Farrell K, Brown C, Clarke J, Davies H. Where have all the copy letters gone? A review of current practice in professional-patient correspondence. Patient Educ Couns. 2008 May;71(2):259-64. doi: 10.1016/j.pec.2007.12.002. Epub 2008 Jan 25.
PubMed 18222056Harris C, Boaden R. Copying letters to patients: the view of patients and health professionals. J Health Serv Res Policy. 2006 Jul;11(3):133-40. doi: 10.1258/135581906777641712.
PubMed 16824259Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
PubMed 12724430Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, Lockwood GA. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1269-74. doi: 10.1001/archotol.128.11.1269.
PubMed 12431168Lawton J, Waugh N, Noyes K, Barnard K, Harden J, Bath L, Stephen J, Rankin D. Improving communication and recall of information in paediatric diabetes consultations: a qualitative study of parents' experiences and views. BMC Pediatr. 2015 Jun 10;15:67. doi: 10.1186/s12887-015-0388-6.
PubMed 26054649Waterston T, San Lazaro C. Sending parents outpatient letters about their children: parents' and general practitioners' views. Qual Health Care. 1994 Sep;3(3):142-6. doi: 10.1136/qshc.3.3.142.
PubMed 10139411A new series starts: the ABC of adolescence. (2005). BMJ, 330(7486).
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Consultation Summaries to Promote Good Health/Views of Adolescents Attending Diabetes Clinic
- ClinicalTrials.gov ID
- NCT04002557
- Acronym / sponsor ID
- ONSET / 18IC4465
- Conditions
- Type1 Diabetes
- Keywords
- diabetes, clinic letter, clinic summary, post-consultation letter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding.
Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.
This research aims explore the views of adolescent patients related to consultation summaries that they receive following a doctor's appointment. The investigator will use patients attending a specialist diabetes clinic as our cohort and conduct a qualitative study using focus groups.
Detailed description
Patient participation in decision making processes about their care promotes patient satisfaction and confidence. As part of this, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Given this, the 2000 NHS plan made it a requirement that all medical correspondence between health professionals is shared with patients.
It is estimated that 40-80% of information discussed during a consultation is forgotten immediately. Written summaries have shown to be an effective method of improving patient recall of information by 20.8%.
The literature on the benefits/disadvantages of consultation summaries is largely focused on adult patients with little research done to explore the views of adolescent population. Where the patient is a child, the literature is only focussed on parents of children and not the children themselves. Limited research has shown that parents/care givers report clinic letters being useful in assisting with better understanding and management of their child's condition.
Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.
Adolescence is an important time of an individual's life. This is the time when many independent health behaviours are established. During adolescence, young people start showing more interest in their own health and often wish to participate in decision making processes regarding their care. The role of health workers at this stage is to appreciate young people as individuals . Clinic summaries addressed directly to young people might play an important role in assisting with establishment of health behaviours and promoting good health in young people.
The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus group | – | Other: Interview-QuestionnaireThis is a qualitative study using focus group discussions with young people aged 12-18 who are receiving consultation summaries. Patients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds. Interviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Young people aged 12-18 years attending a single diabetes outpatient clinic were invited to enrol. This clinic served patients from a wide geographical area across London and the South-East England with broad socio-economic status, diabetes control and ethnicity.
Key inclusion criteria (1 listed)
- Adolescents aged 12-18 years attending UCLH adolescent diabetes outpatient clinic
Key exclusion criteria (2 listed)
- Young people who cannot speak English (effective communication with colleagues during the study is the major aspect of valid data collection)
- Young people who refuse to participate in focus group discussions
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 |
|---|---|---|
| Interview-QuestionnaireQuestionnaire | Other | Focus group |
Primary outcome
Number of Participants That Completed Interviews About Consultation Summaries They Were Receiving
Time frame: 1 month
The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15499057Bartle DG, Diskin L, Finlay F. Copies of clinic letters to the family. Arch Dis Child. 2004 Nov;89(11):1032-3. doi: 10.1136/adc.2004.051938.
- Background: PubMed 18222056Baxter S, Farrell K, Brown C, Clarke J, Davies H. Where have all the copy letters gone? A review of current practice in professional-patient correspondence. Patient Educ Couns. 2008 May;71(2):259-64. doi: 10.1016/j.pec.2007.12.002. Epub 2008 Jan 25.
- Background: PubMed 16824259Harris C, Boaden R. Copying letters to patients: the view of patients and health professionals. J Health Serv Res Policy. 2006 Jul;11(3):133-40. doi: 10.1258/135581906777641712.
- Background: PubMed 12724430Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
- Background: PubMed 12431168Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, Lockwood GA. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1269-74. doi: 10.1001/archotol.128.11.1269.
- Background: PubMed 26054649Lawton J, Waugh N, Noyes K, Barnard K, Harden J, Bath L, Stephen J, Rankin D. Improving communication and recall of information in paediatric diabetes consultations: a qualitative study of parents' experiences and views. BMC Pediatr. 2015 Jun 10;15:67. doi: 10.1186/s12887-015-0388-6.
- Background: PubMed 10139411Waterston T, San Lazaro C. Sending parents outpatient letters about their children: parents' and general practitioners' views. Qual Health Care. 1994 Sep;3(3):142-6. doi: 10.1136/qshc.3.3.142.
- BackgroundA new series starts: the ABC of adolescence. (2005). BMJ, 330(7486).
- Good Practice Guidelines - Department of Health, 2004Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
David Inwald principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1 Diabetes, 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 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 22 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2024). 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 Participants That Completed Interviews About Consultation Summaries They Were Receiving (time frame: 1 month). 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 NCT04002557, which also lists 8 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 22 Apr 2024.