- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07585708
Learning Differences in Medical Education
What Are the Patient and Medical Student Perspectives on the Learning Needs and Expectations of Training of Future Doctors in Healthcare for Individuals With Learning Differences?
A learning difference or disability is a reduction in intellectual ability (GMC, 2024). It causes lifelong difficulty with everyday activities. Different individuals require different levels of support. Individuals with learning disability may also have learning difficulties and mental health problems, but these conditions do not always co-exist. Learning difficulties affect the way someone processes information. They are not related to intelligence but can affect learning and education. People with learning differences can experience higher rates of mental and physical ill-health. The individual's life expectancy is shorter than the average for the population. This is related to access and experience of health care. These patients may experience discrimination affecting their healthcare.
Discrimination arises from staff and organisational attitudes towards patients and judgements about their quality of life. These individuals' care is also at risk of diagnostic overshadowing where a patient's symptoms are attributed to their disability rather than a disease. Many people with learning disabilities may find it harder to use healthcare services, and the investigators want to find out what challenges these individuals face. For example, do these patient have trouble understanding what is being said to them? Are there issues with getting an appointment or understanding the information about their health?
This project focuses on understanding the experiences of people with learning disabilities when they use health services. How easily do can these individuals communicate with their clinician? Are there barriers in accessing care? Do these individuals feel respected and listened to during their appointments? How should healthcare staff be trained to provide better care to these patients? The investigators will be speaking directly to patients with learning disabilities living in Derbyshire. This will be by interviews encouraging the patients to share their thoughts and experiences. The information the investigators gather will help understand these people's experiences of healthcare and how this could be improved. The investigators will also undertake an anonymised survey of medical students on their perceived learning needs regarding individuals with learning differences. This information will be used to develop educational resources for clinical teachers. medical students and staff. Working with the volunteers will better prepare future doctors to provide holistic care for patients with learning differences.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
A learning difference or disability is a reduction in intellectual ability. It causes lifelong difficulty with everyday activities. Different individuals require different levels of support. Individuals with learning disability may also have learning difficulties and mental health problems, but they do not always co-exist. Learning difficulties affect the way someone processes information. They are not related to intelligence but can affect learning and education. Examples include dyslexia and attention deficit hyperactivity disorder (ADHD). People with learning differences can experience higher rates of mental and physical ill-health. The life expectancy of individuals with learning difficulties is shorter than the average for the population. This is related to access and experience of health care. Poor quality care severely affects outcomes for these patients, for example during Covid-19. The rate of avoidable death in people with learning disabilities is twice that of the general population. These patients may experience discrimination affecting their healthcare. Diagnostic overshadowing in which new mental and physical symptoms are wrongly attributed to an existing condition or disability are more common in individuals with learning differences and contributes to poorer outcomes.
The lack of training for healthcare staff, both pre- and post-qualification, is recognised as contributing to poor-quality care of patients with learning differences. The UK General Medical Council (GMC) recognises the need to address this in its ethical guidance to doctors. Furthermore, it has developed a learning package to guide practitioners. The GMC recommends staff training which is led by individuals with a learning difference. There is variation in educational interventions for teaching medical students about learning differences. These include classroom-based teaching, simulation with actors, individual placements, home visits and panel discussions. These interventions tend to be teaching about the patient rather than with the patient. Furthermore, study quality is poor with use of non-validated measures making assessments problematic.
Patients are stakeholders and the greatest experts in their own healthcare needs. Leaving no-one behind means listening to all patients, engaging in dialogue and learning to see things from the patient's perspective. This study will examine the co-production of a volunteer-student teaching session to improve the understanding of future doctors of this important area.
Co-production in healthcare planning and delivery is well established including in medical education. The School of Medicine at the University of Nottingham has a long-standing reputation for working in partnership with members of the public. People have contributed to teaching and assessment in innovative ways, and the School has regularly jointly produced publications and co-presented at conferences. Engagement with patients recognises their dignity. It integrates the four ethical pillars - beneficence (do good), non-maleficence (do no harm), autonomy - (self-determination, shared decision-making) and justice (fairness to all).
This study examines patient-student co-production in the context of educating medical students through collaboration with volunteers who have the lived experience of a learning difference. The collaboration will assess this process from conception to identification of volunteer experience and student learning needs, preparation of resources, delivery of an interactive session working with volunteers and reflection on the strengths and limitations of the educational intervention. The study will assist development of longitudinal resources for supporting students' ability to learn to provide high quality care holistic for individuals with learning differences.
Main research question What are the perspectives of the individual with a learning difference and of medical students on the learning needs and expectations of training of future doctors in healthcare for individuals with learning differences?
Supplementary question Can these begin to be addressed through a volunteer-led teaching and learning dialogue with graduate entry preclinical students?
Data collection methods
Data for the study will be collected using a mixed methods approach and will involve:
- Initial qualitative interviews with volunteers and carers who have offered to come and speak to patients about their healthcare as individuals with a personal history of learning differences
- Online survey of baseline learning and self-assessment of learning needs of graduate entry preclinical medical students in the second year of their training
- Pre- and post-session quantitative evaluation by the students of the delivery of a session on healthcare for individuals with learning differences
Summary of known and potential risks and benefits
The benefits include an increased level and understanding among students and staff of the lived experience of individuals with learning differences. It may also increase confidence and belief among the volunteers and their carers of a willingness of healthcare staff and future doctors in wishing to engage, support and help patients with learning differences.
It will assist students' understanding of communicating sensitively with patients with learning differences around their possible experiences around their learning difference, and their previous experiences of engagement with healthcare services and staff.
It will also enable students to discuss and practice use of communication skills when working with individuals with learning differences (NB: The patients will not be physically examined during the teaching session, but the practicalities of physical examination or of procedures of having, for example, blood tests may form part of the group discussions).
Interviews/ questionnaires or group discussions may include topics that might be sensitive, embarrassing or upsetting either to the volunteers or to students experiencing similar feelings in their own lives or family and friends. It is possible that other disclosures (e.g. previous unprofessional behaviours by healthcare staff) requiring action could occur during the study?
Description of the population to be studied and special considerations
The study population will be 10-15 volunteers and their carers attending to discuss their healthcare experience and up to 120 Year 2 graduate entry medical students. Special considerations will be ensuring all participants are fully informed prior to consent regarding the use of data for analysis and storage. Psychological safety should be provided to participants and compliance with university safeguarding procedures should be in place in the event of participant distress.
Consent
This is a vulnerable group. Possible participants in the study have been identified from volunteers attending to participate in a pilot teaching session to GEM medical students held in September and October 2025. Professor John Frain is the Principal Investigator for the project. The prospective participants are either individuals with a learning difference or their carers. Volunteers will only be admitted to the study if both they and their carers are able to give informed consent.
The volunteers will be invited to either attend a room at the university set aside for the interview or to be interviewed on MS Teams. Some of the participants at the pilot teaching session were from a self-advocacy community group based in the East Midlands, UK. This is not an NHS-related education but is used as a placement for University of Nottingham students in clinical phase. Interviews with volunteers with a personal history of learning differences may take place at this location for the convenience of interviewees.
Interviewers will go through the information leaflet and consent form with both volunteer and carer. Additional time may be required for this, and this will be factored into the time required for the interview. If a volunteer is found not to have capacity to provide informed consent, they will not proceed further in the study.
Carers will also be consented to be key informants during the interview, but they will not be consented to speak on behalf of the patient or to interpret the thoughts of feelings of the volunteers.
Volunteers will be reminded of their right to decline to take part or withdraw without consequence.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Professor John Frain
- Telefonnummer: +447831338172
- E-Mail: john.frain@nottingham.ac.uk
Studienorte
-
-
-
Derby, Vereinigtes Königreich, DE22 3DT
- Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham Medical School at the Royal Derby Hospital
-
Kontakt:
- Professor John Frain
- Telefonnummer: +441332724618
- E-Mail: john.frain@nottingham.ac.uk
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Volunteers will be recruited from participants in teaching sessions to GEM medical students held in September and October 2025. This will be using convenience sampling. Up to 120 students currently on the GEM Year 1 preclinical programme at the time of the study will be invited to complete the study.
Exclusion Criteria:
- All who do not meet the inclusion criteria defined above
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Learning Difference volunteers
Individuals with either a personal history of learning difference or carer role either as a member member or employed carer
|
Individual participants experience of access and receiving healthcare.
Individuals insights and reflections on the educational needs of doctors and medical students in the needs of individuals with learning differences
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Individual and medical student perspectives on the learning needs and expectations of training of future doctors in healthcare for individuals with learning differences
Zeitfenster: 8 months
|
Data drawn from interviews with volunteers with personal history of learning difference and a survey of preclinical medical students
|
8 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Can these needs and expectations be met through a volunteer-led teaching and learning dialogue with graduate entry preclinical students?
Zeitfenster: 8 months
|
Outcome of teaching where the content is based on the themes identified in the interviews with volunteers and the survey
|
8 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: John PJ Frain, Univeristy of Nottingham
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Javaid, A., Nakata, V. and Michael, D. (2019), Diagnostic overshadowing in learning disability: think beyond the disability. Prog. Neurol. Psychiatry, 23: 8-10. https://doi.org/10.1002/pnp.531
- White A, Sheehan R, Ding J, Roberts C, Magill N, Keagan-Bull R, Carter B, Ruane M, Xiang X, Chauhan U, Tuffrey-Wijne I, Strydom A. Learning from lives and deaths - people with a learning disability and autistic people (LeDeR) report for 2021 (LeDeR 2021). King's College, London: Autism and learning disability partnership; 2022.
- Doebrich A, Quirici M, Lunsford C. COVID-19 and the need for disability conscious medical education, training, and practice. J Pediatr Rehabil Med. 2020;13(3):393-404. doi: 10.3233/PRM-200763.
- Salvador-Carulla L, Martinez-Leal R, Heyler C, Alvarez-Galvez J, Veenstra MY, Garcia-Ibanez J, Carpenter S, Bertelli M, Munir K, Torr J, Van Schrojenstein Lantman-de Valk HM. Training on intellectual disability in health sciences: the European perspective. Int J Dev Disabil. 2015 Jan;61(1):20-31. doi: 10.1179/2047387713Y.0000000027.
- Gregoire B, Trager L, Blum J. Coproduction in medical education during the COVID-19 pandemic: critical components of successful curricular reform. Int J Qual Health Care. 2021 Nov 29;33(Supplement_2):ii65-ii70. doi: 10.1093/intqhc/mzab126.
- Towson G, Daley S, Banerjee S. Intellectual disabilities teaching for medical students: a scoping review. BMC Med Educ. 2023 Nov 1;23(1):818. doi: 10.1186/s12909-023-04766-4.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UNottingham FMHS 153-0525
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Lernschwächen
-
RenJi HospitalNoch keine RekrutierungDeep Learning, lumbale Magnetresonanztomographie
-
Chelsea and Westminster NHS Foundation TrustNational Institute for Health Research, United Kingdom; OCB MediaAbgeschlossenQualitätsverbesserung | Lernen | E-LearningVereinigtes Königreich
-
Gazi UniversityAtılım University; Gazi University Scientific Research UnitAbgeschlossenPflegeausbildung | Pflege | Thoraxtubus | E-LearningTruthahn
-
Kırıkkale UniversityAnmeldung auf EinladungSpirituelle Betreuung | Flipped Learning ModellTürkei (türkiye)
-
Hai LvAktiv, nicht rekrutierendFacettengelenke; Entartung; Deep Learning; Künstliche IntelligenzChina
-
National Cheng-Kung University HospitalAnmeldung auf EinladungChemotherapie | Intensivstation | Krankenschwester | Selbstwirksamkeit | E-LearningTaiwan
-
Sultan Qaboos Comprehensive Cancer CenterNoch keine Rekrutierung
-
Orsi AcademyAbgeschlossen
-
Cairo UniversityNoch keine RekrutierungEndodontie | KI (Künstliche Intelligenz) | Deep-Learning-Modell | Zähnung | Verpasste Kanäle | Endodontische Nachbehandlung | Non-surgical Retreatment | DIFFICULTY ASSESSMENT | SEPARATED INSTRUMENT | Poor Obturation | Obturation Quality
-
Maastricht University Medical CenterAktiv, nicht rekrutierendAktinische Keratose | Dermatologie | E-LearningNiederlande
Klinische Studien zur Experience of healthcare
-
University Hospital, RouenNoch keine Rekrutierung
-
Maastricht UniversityTNO; Netherlands Instititute for Health Services Research; University of TwenteAbgeschlossenHerzfehler | Diabetes mellitus, Typ 2 | Chronisch obstruktive Lungenerkrankung | AsthmaNiederlande
-
Temple UniversityAbgeschlossenBild, KörperVereinigte Staaten
-
Memorial Sloan Kettering Cancer CenterAbgeschlossenAszitesVereinigte Staaten
-
Buddhist Tzu Chi General HospitalAbgeschlossen
-
Medical University of ViennaZurückgezogenTelemedizin | EchokardiographieÖsterreich
-
University of Alabama at BirminghamZurückgezogenPhysische AktivitätVereinigte Staaten
-
University of ChicagoNational Heart, Lung, and Blood Institute (NHLBI); COPD Foundation; Society of... und andere MitarbeiterRekrutierungCOPD | COPD Exazerbation AkutVereinigte Staaten
-
Memorial Sloan Kettering Cancer CenterBeendetDie Familien oder nächsten Angehörigen von Patienten, die am MSKCC wegen nichtkutaner Plattenepithelkarzinome behandelt wurden | Oberer AerodigestivtraktVereinigte Staaten
-
Buddhist Tzu Chi General HospitalAbgeschlossen