Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial
Introduction Persistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England’s annual National Health Service costs of attempting to diagnose and treat PPS amounts to approxim...
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BMJ Publishing Group
2019-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/7/e025513.full |
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| author | Matthew Hotopf Rona Moss-Morris Paul McCrone Sabine Landau Trudie Chalder Mark Ashworth Meenal Patel Kirsty James Mujtaba Husain Philipp Frank Nicola Ferreira Iris Mosweu Anthony David |
| author_facet | Matthew Hotopf Rona Moss-Morris Paul McCrone Sabine Landau Trudie Chalder Mark Ashworth Meenal Patel Kirsty James Mujtaba Husain Philipp Frank Nicola Ferreira Iris Mosweu Anthony David |
| author_sort | Matthew Hotopf |
| collection | DOAJ |
| description | Introduction Persistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England’s annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.Methods and analysis A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to ‘integrated GP care plus treatment as usual’ or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks’ postrandomisation, using a mixed-methods approach.Ethics and dissemination Ethical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.Trial registration number NCT02444520; Pre-results. |
| format | Article |
| id | doaj-art-4a89f0b6fea8402fb95853b5a08183e0 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4a89f0b6fea8402fb95853b5a08183e02024-11-23T07:35:07ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-025513Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trialMatthew Hotopf0Rona Moss-Morris1Paul McCrone2Sabine Landau3Trudie Chalder4Mark Ashworth5Meenal Patel6Kirsty James7Mujtaba Husain8Philipp Frank9Nicola Ferreira10Iris Mosweu11Anthony David121 Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK1King’s College London, London, UK7 Health Service & Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, UKDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UKPsychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King`s College London, London, UKSchool of Population Health and Environmental Sciences, King`s College London, London, UK1 Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK2 King’s Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UK24 Persistent Physical Symptom Service, South London and Maudsley NHS Foundation Trust, London, UK1 Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK1 Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK4 Department of Health Policy, London School of Economics, London, UK7 Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UKIntroduction Persistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England’s annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.Methods and analysis A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to ‘integrated GP care plus treatment as usual’ or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks’ postrandomisation, using a mixed-methods approach.Ethics and dissemination Ethical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.Trial registration number NCT02444520; Pre-results.https://bmjopen.bmj.com/content/9/7/e025513.full |
| spellingShingle | Matthew Hotopf Rona Moss-Morris Paul McCrone Sabine Landau Trudie Chalder Mark Ashworth Meenal Patel Kirsty James Mujtaba Husain Philipp Frank Nicola Ferreira Iris Mosweu Anthony David Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial BMJ Open |
| title | Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial |
| title_full | Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial |
| title_fullStr | Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial |
| title_full_unstemmed | Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial |
| title_short | Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial |
| title_sort | persistent physical symptoms reduction intervention a system change and evaluation prince integrated gp care for persistent physical symptoms protocol for a feasibility and cluster randomised waiting list controlled trial |
| url | https://bmjopen.bmj.com/content/9/7/e025513.full |
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