Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Implementation Science
Published in: Implementation Science 1/2012

Open Access 01-12-2012 | Study protocol

A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol

Authors: Peter Bower, Anne Kennedy, David Reeves, Anne Rogers, Tom Blakeman, Carolyn Chew-Graham, Robert Bowen, Martin Eden, Caroline Gardner, Mark Hann, Victoria Lee, Rebecca Morris, Joanne Protheroe, Gerry Richardson, Caroline Sanders, Angela Swallow, David Thompson

Published in: Implementation Science | Issue 1/2012

Login to get access

Abstract

Background

Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation. There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient populations, but little consensus concerning the optimal model that would best provide such support. We describe the implementation and evaluation of self-management support through an evidence-based 'whole systems' model involving patient support, training for primary care teams, and service re-organisation, all integrated into routine delivery within primary care.

Methods

The evaluation involves a large-scale, multi-site study of the implementation, effectiveness, and cost-effectiveness of this model of self-management support using a cluster randomised controlled trial in patients with three long-term conditions of diabetes, chronic obstructive pulmonary disease (COPD), and irritable bowel syndrome (IBS). The outcome measures include healthcare utilisation and quality of life. We describe the methods of the cluster randomised trial.

Discussion

If the 'whole systems' model proves effective and cost-effective, it will provide decision-makers with a model for the delivery of self-management support for populations with long-term conditions that can be implemented widely to maximise 'reach' across the wider patient population.

Trial registration number

ISRCTN: ISRCTN90940049
Appendix
Available only for authorised users
Literature
1.
Lopez A, Mathers C, Ezzati M, Jamison D, Murray C: Measuring the Global Burden of Disease and Risk Factors, 1990-2001. Global Burden of Disease and Risk Factors. Edited by: Lopez A, Mathers C, Ezzati M, Jamison D, Murray C. 2006, New York: The World Bank and Oxford University Press, 1-14.CrossRef
2.
3.
Department of Health: Self care-a real choice: self care support-a practical option. 2005, London
4.
Wanless D: Securing our Future Health: taking a long term view. 2002, London
5.
Rogers A, Bury M, Kennedy A: Rationality, rhetoric, and religiosity in health care: the case of England's Expert Patients Programme. International Journal of Health Services. 2009, 4: 725-747.CrossRef
6.
7.
8.
Barlow J, Singh D, Bayer S, Curry R: A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. Journal of Telemedicine and Telecare. 2007, 13: 172-179. 10.1258/135763307780908058.CrossRefPubMed
9.
Murray E, Burns J, See Tai S, Lai R, Nazareth I: Interactive Health Communication Applications for people with chronic disease. Cochrane Database of Systematic Reviews. 2005,Issue 4. Art. No.: CD004274. DOI: 10.1002/14651858.CD004274.pub4,
10.
Lorig K, Sobel D, Stewart A, Brown B, Bandura A, Ritter P, Gonzalez V, Laurent D, Holman H: Evidence suggesting that chronic disease self management can improve health status while reducing hospitalisation: a randomized trial. Med Care. 1999, 37: 5-14. 10.1097/00005650-199901000-00003.CrossRefPubMed
11.
Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A: The effectiveness and cost effectiveness of a national lay led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007, 61: 254-261. 10.1136/jech.2006.053538.CrossRefPubMedPubMedCentral
12.
Griffiths C, Foster G, Ramsay J, Eldridge S, Taylor S: How effective are expert patient (lay led) education programmes for chronic disease?. BMJ. 2007, 334: 1254-1256. 10.1136/bmj.39227.698785.47.CrossRefPubMedPubMedCentral
13.
Glasgow R, Vogt T, Boles S: Evaluating the Public Health Impact of Health Promotion Interventions: The RE-AIM Framework. Am J Public Health. 1999, 89: 1322-1327. 10.2105/AJPH.89.9.1322.CrossRefPubMedPubMedCentral
14.
Glasgow R, McKay H, Piette J, Reynolds K: The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic disease management?. Pat Educ Couns. 2001, 44: 119-127. 10.1016/S0738-3991(00)00186-5.CrossRef
15.
Lee V, Kennedy A, Rogers A: Implementing and managing self-management skills training within primary care organisations: a national survey of the expert patients programme within its pilot phase. Implementation Science. 2006, 1:
16.
NPCRDC: How has the EPP been delivered and accepted in the NHS during the pilot phase?. 2005, University of Manchester
17.
Institute of Medicine: Primary care: America's health in a new era. 1996, Washington: National Academy Press
18.
Parchman M, Pugh J, Romero R, Bowers K: Competing demands or clinical inertia: the case of elevated glycosylated hemoglobin. Ann Fam Med. 2007, 5: 196-201. 10.1370/afm.679.CrossRefPubMedPubMedCentral
19.
MacDonald W, Rogers A, Blakeman T, Bower P: Practice nurses and the facilitation of self-management in primary care. J Adv Nurs. 2008, 62: 191-199. 10.1111/j.1365-2648.2007.04585.x.CrossRefPubMed
20.
Blakeman T, MacDonald W, Bower P, Gately C, Chew-Graham C: A qualitative study of GPs' attitudes to self-management of chronic disease. Br J Gen Pract. 2006, 56: 407-414.PubMedPubMedCentral
21.
Checkland K, Harrison S, McDonald R, Grant S, Campbell S, Guthrie B: Biomedicine, holism and general medical practice: responses to the 2004 General Practitioner contract. Sociology of Health and Illness. 2008, 30: 788-803. 10.1111/j.1467-9566.2008.01081.x.CrossRefPubMed
22.
Kendall E, Rogers A: Extinguishing the social?: State sponsored self-care policy and the Chronic Disease Management Programme. Disability and Society. 2007, 22: 129-143. 10.1080/09687590601141535.CrossRef
23.
Sibbald B, Roland M: Getting research into practice. J Eval Clin Pract. 1997, 2: 15-21.CrossRef
24.
Rogers A, Vassilev I, Sanders C, Kirk S, Chew-Graham C, Kennedy A, Protheroe J, Bower P, Blickem C, Reeves D, Kapadia D, Brooks H, Fullwood C, Richardson G: Social networks, work and network-based resources for the management of long-term conditions: a framework and study protocol for developing self-care support. Implementation Science. 2011, 6: 56-10.1186/1748-5908-6-56.CrossRefPubMedPubMedCentral
25.
Bury M, Newbould J, Taylor D: A rapid review of the current state of knowledge regarding lay led self management of chronic illness: Evidence review. 2005, London
26.
Greenhalgh T: Patient and public involvement in chronic illness: beyond the expert patient. BMJ. 2009, 338: b49-10.1136/bmj.b49.CrossRefPubMed
27.
28.
Kennedy A, Rogers A: Improving self-management skills: a whole systems approach. Br J Nurs. 2001, 10: 734-737.CrossRefPubMed
29.
Rogers A, Entwistle V, Pencheon D: A patient led NHS: managing demand at the interface between lay and primary care. BMJ. 1998, 316: 1816-1819. 10.1136/bmj.316.7147.1816.CrossRefPubMedPubMedCentral
30.
31.
Medical Research Council: Developing and evaluating complex interventions: new guidance. 2008, London
32.
Kennedy A, Robinson A, Thompson D, Wilkin D: Development of a guidebook to promote patient participation in the management of ulcerative colitis. Health Soc Care Community. 1999, 7: 177-186. 10.1046/j.1365-2524.1999.00174.x.CrossRefPubMed
33.
Kennedy A, Robinson A, Rogers A: Incorporating patients' views and experiences of life with IBS in the development of an evidence based self-help guidebook. Pat Educ Couns. 2003, 50: 303-310. 10.1016/S0738-3991(03)00054-5.CrossRef
34.
Kennedy A, Rogers A: Improving patient involvement in chronic disease management: the views of patients, GPs and specialists on a guidebook for ulcerative colitis. Pat Educ Couns. 2002, 47: 257-263. 10.1016/S0738-3991(01)00228-2.CrossRef
35.
Kennedy A, Nelson E, Reeves D, Richardson G, Robinson A, Rogers A, Sculpher M, Thompson D: A randomised controlled trial to assess effectiveness and cost of a patient orientated self-management approach to chronic inflammatory bowel disease. Gut. 2004, 53: 1639-1645. 10.1136/gut.2003.034256.CrossRefPubMedPubMedCentral
36.
Kennedy A, Robinson J, Hann M, Thompson D, Wilkin D: A cluster randomized controlled trial of a patient-centred guidebook for patients with ulcerative colitis: effect on knowledge, anxiety and quality of life. Health Soc Care Community. 2003, 11: 64-72. 10.1046/j.1365-2524.2003.00399.x.CrossRefPubMed
37.
Robinson A, Thompson D, Wilkin D, Roberts C, Northwest Gastrointestinal Research Group: Guided self-management and patient-directed follow-up of ulcerative colitis: a randomised trial. Lancet. 2001, 358: 976-981. 10.1016/S0140-6736(01)06105-0.CrossRefPubMed
38.
Kennedy A, Gask L, Rogers A: Training professionals to engage with and promote self-management. Health Edu Res. 2005, 20: 567-578. 10.1093/her/cyh018.CrossRef
39.
Richardson G, Sculpher M, Kennedy A, Nelson E, Reeves D, Roberts C, Robinson A, Rogers A, Thompson D: Is self care a cost effective use of resources? Evidence from a randomised trial in inflammatory bowel disease. J Health Serv Res Policy. 2006, 11: 225-230. 10.1258/135581906778476508.CrossRefPubMed
40.
Robinson A, Lee V, Kennedy A, Middleton E, Rogers A, Thompson DG, Reeves D: A randomised controlled trial of self-help interventions in patients with a primary care diagnosis of irritable bowel syndrome. Gut. 2006, 55: 643-648. 10.1136/gut.2004.062901.CrossRefPubMedPubMedCentral
41.
Rogers A, Kennedy A, Nelson E, Robinson A: Patients' experiences of an open access follow up arrangement in managing inflammatory bowel disease. Qual Saf Health Care. 2004, 13: 374-378. 10.1136/qshc.2003.008292.CrossRefPubMedPubMedCentral
42.
Rogers A, Lee V, Kennedy A: Continuity and change?: Exploring reactions to a guided self-management intervention in a randomised controlled trial for IBS with reference to prior experience of managing a long term condition. Trials. 2007, 8: doi:10.1186/1745-6215-8-6
43.
Rogers A, Kennedy A, Nelson E, Robinson A: Uncovering the limits of patient-centeredness: implementing a self-management trial for chronic illness. Qual Health Res. 2005, 15: 224-239. 10.1177/1049732304272048.CrossRefPubMed
44.
Kennedy A, Chew-Graham C, Blakeman T, Bowen A, Gardner C, Protheroe J, Rogers A, Gask L: Delivering the WISE (Whole Systems Informing Self-Management Engagement) training package in primary care: learning from formative evaluation. Implementation Science. 2010, 5: 7-10.1186/1748-5908-5-7.CrossRefPubMedPubMedCentral
45.
46.
Deakin T, McShane C, Cade J, Williams R: Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 2005,Issue 2-art. no. CD003417.pub2,
47.
Monninkhof E, van der Valk P, van Herwaarden C, van der Palen J, Partridge M, Walter E, Zielhuis G: Self management education for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews. 2007, Art. No.: CD002990. DOI: 10.1002/14651858.CD002990
48.
Department of Health: The NHS Improvement Plan: putting people at the heart of public services. 2004, Norwich
49.
BMA NE: Quality and Outcomes Framework guidance for GMS contract 2009/10. Delivering investment in general practice. 2009, London
50.
Protheroe J, Blakeman T, Bower P, Chew-Graham C, Kennedy A: An intervention to promote patient participation and self-management in long term conditions: development and feasibility testing. BMC Health Services Research. 2010, 10: 206-10.1186/1472-6963-10-206.CrossRefPubMedPubMedCentral
51.
Gask L, McGrath G, Goldberg D, Millar T: Improving the psychiatric skills of established general practitioners: evaluation of group teaching. Med Educ. 1987, 21: 362-368. 10.1111/j.1365-2923.1987.tb00377.x.CrossRefPubMed
52.
Gask L, Boardman A, Standart S: Teaching Communication Skills: A problem-based approach. Postgraduate Education for General Practice. 1990, 2: 7-15.
53.
Richardson G, Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Gardner C, Gately C, Rogers A: Cost-effectiveness analysis of a national lay led self care support programme for patients with long-term conditions. J Epidemiol Community Health. 2008, 62: 361-367. 10.1136/jech.2006.057430.CrossRefPubMed
54.
Netten A, Dennet J, Knight J: Unit Costs of Health and Social Care. 1998, University of Kent, Canterbury: Personal Social Services Research Unit
55.
Drummond M, Stoddart G, Torrance G: Methods for the economic evaluation of health care programmes. 1997, Oxford: Oxford Medical Publications
56.
Kind P: The EuroQoL instrument: an index of health-related quality of life. Quality of Life and Pharmacoeconomics in Clinical Trials. Edited by: Spilker B. 1996, Philadelphia: Lippincott-Raven
57.
Briggs A, Sculpher M, Dawson J, Fitzpatrick R, Murray D, Malchau H: The use of probabilistic decision models in technology assessment: the case of total hip replacement. Applied Health Economics and Health Policy. 2004, 3: 79-89. 10.2165/00148365-200403020-00004.CrossRefPubMed
58.
Fenwick E, Claxton K, Sculpher M: Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2002, 10: 779-787.CrossRef
59.
Van Hout B, Al M, Gordon G, Rutten F: Costs, effects, and C/E ratios alongside a clinical trial. Health Econ. 1994, 3: 309-313. 10.1002/hec.4730030505.CrossRefPubMed
60.
61.
Edwards P, Roberts I, Clarke M, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix L, Pratap S: Methods to increase response to postal and electronic questionnaires. Cochrane Database of Systematic Reviews. 2009,Issue 3. Art. No.: MR000008. DOI: 10.1002/14651858.MR000008.pub4,
62.
Williams G, Freedman Z, Deci E: Supporting autonomy to motivate patients with diabetes for glucose control. Diabet Care. 1998, 21: 1644-1651. 10.2337/diacare.21.10.1644.CrossRef
63.
Williams G, McGregor H, Zeldman A, Freedman Z, Deci E: Testing a self-determination theory process model for promoting glycemic control through diabetes self-management. Health Psychol. 2004, 23: 58-66.CrossRefPubMed
64.
Williams G, McGregor H, Kind D, Nelson C, Glasgow R: Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Pat Educ Couns. 2005, 57: 39-45. 10.1016/j.pec.2004.04.001.CrossRef
65.
Ludman E, Simon G, Rutter C, Bauer M, Unützer J: A measure for assessing patient perception of provider support for self -management of bipolar disorder. Bipolar disorders. 2002, 4: 249-253. 10.1034/j.1399-5618.2002.01200.x.CrossRefPubMed
66.
Lorig K, Stewart A, Ritter P, Gonzalez V, Laurent D, Lynch J: Outcome measures for health education and other health care interventions. 1996, Thousand Oaks: Sage
67.
Howie J, Heaney D, Maxwell M, Walker J: A comparison of Patient Enablement Instrument (PEI) against two established satisfaction scales as an outcome measure of primary care consultations. Fam Pract. 1998, 15: 165-171. 10.1093/fampra/15.2.165.CrossRefPubMed
68.
Mead N, Bower P, Roland M: Factors associated with enablement in general practice: cross sectional study using routinely collected data. Br J Gen Pract. 2008, 58: 346-352. 10.3399/bjgp08X280218.CrossRefPubMedPubMedCentral
69.
Lorig K, Seleznick M, Lubeck D, Ung E, Chastain R, Holman H: The beneficial outcomes of the arthritis self-management course are not adequately explained by behaviour change. Arthritis Rheum. 1989, 32: 91-95. 10.1002/anr.1780320116.CrossRefPubMed
70.
McDonald-Miszczak L, Wister A: Predicting self-care behaviours among older adults coping with arthritis. Journal of Aging and Health. 2005, 17: 836-857. 10.1177/0898264305280984.CrossRefPubMed
71.
Toobert D, Hampson S, Glasgow R: The summary of diabetes self-care activities measure: results from seven studies and revised scale. Diabet Care. 2000, 23: 943-950. 10.2337/diacare.23.7.943.CrossRef
72.
Eakin E, Glasgow R: The patients' perspective on the self-management of chronic obstructive pulmonary disease. J Health Psychol. 1997, 2: 245-253.CrossRefPubMed
73.
Cicutto L, Brooks D: Self-care approaches to managing chronic obstructive pulmonary disease: a provincial survey. Respir Med. 2006, 100: 1540-1546. 10.1016/j.rmed.2006.01.005.CrossRefPubMed
74.
Glasgow R, Wagner E, Schaefer J, Mahoney L, Reid R, Greene S: Development and validation of the Patient Assessment of Chronic Illness Care. Med Care. 2005, 43: 436-444. 10.1097/01.mlr.0000160375.47920.8c.CrossRefPubMed
75.
Hyland M, Singh S, Sodergren S, Morgan M: Development of a shortened version of the Breathing Problems Questionnaire suitable for use in a pulmonary rehabilitation clinic: a purpose-speciifc, disease-specific questionnaire. Qual Life Res. 1998, 7: 227-233. 10.1023/A:1008826014337.CrossRefPubMed
76.
Hyland M, Bott J, Singh S, Kenyon C: Domains, constructs, and the development of the breathing problems questionnaire. Qual Life Res. 1994, 3: 245-256. 10.1007/BF00434898.CrossRefPubMed
77.
Burroughs T, Desikan R, Waterman B, Gilin D, McGill J: Development and validation of the diabetes quality of life brief clinical inventory. Diabetes Spectrum. 2004, 17: 41-49. 10.2337/diaspect.17.1.41.CrossRef
78.
Patrick D, Drossman D, Frederick I, Dicesare J, Puder K: Quality of life in persons with irritable bowel syndrome. Digestive Diseases and Sciences. 1998, 43: 400-411. 10.1023/A:1018831127942.CrossRefPubMed
79.
Hagger M, Orbell S: A meta analytic review of the common sense model of illness representations. Psychol Health. 2003, 18: 141-184. 10.1080/088704403100081321.CrossRef
80.
Broadbent E, Petrie K, Main J, Weinman J: The Brief Illness Perceptions Questionnaire. J Psychosom Res. 2006, 60: 631-637. 10.1016/j.jpsychores.2005.10.020.CrossRefPubMed
81.
Weinman J, Petrie K, Moss-Morris R, Horne R: The illness perception questionnaire: a new method for assessing the cognitive representation of illness. Psychol Health. 1996, 11: 431-445. 10.1080/08870449608400270.CrossRef
82.
Department of Health and Human Services (USA): Healthy People 2010. 2004
83.
Pescosolido BA, Levy J: The role of social networks in health, illness, disease and healing: the accepting present, the forgotten past, and the dangerous potential for a complacent future. Social Networks and Health. Edited by: Pescosolido BA, Levy J. 2002, New York: JAI, 3-28.CrossRef
84.
Petrou S, Kupek E: Social capital and its relationship with measures of health status: evidence from the health survey for England 2003. Health Econ. 2008, 17: 143-CrossRef
85.
86.
May C: A rational model for assessing and evaluating complex interventions in health care. BMC Health Services Research. 2006, 6: 86-10.1186/1472-6963-6-86.CrossRefPubMedPubMedCentral
87.
May C, Finch T: Implementing, embedding, and integrating practices: an outline of normalization process theory. Sociology. 2009, 43: 535-554.CrossRef
88.
Gately C, Rogers A, Sanders C: Re-thinking the relationship between long-term condition self-management education and the utilisation of health services. Soc Sci Med. 2007, 65: 934-945. 10.1016/j.socscimed.2007.04.018.CrossRefPubMed
89.
Antonucci T, Akiyama H: Social networks in adult life and a preliminary examination of the convoy model. Journals of Gerontology. 1987, 42: 519-527.CrossRefPubMed
90.
Patton M: Qualitative Research and Evaluation Methods. 2001, Thousand Oaks: Sage
Metadata
Title
A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol
Authors
Peter Bower
Anne Kennedy
David Reeves
Anne Rogers
Tom Blakeman
Carolyn Chew-Graham
Robert Bowen
Martin Eden
Caroline Gardner
Mark Hann
Victoria Lee
Rebecca Morris
Joanne Protheroe
Gerry Richardson
Caroline Sanders
Angela Swallow
David Thompson
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2012
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/1748-5908-7-7

Other articles of this Issue 1/2012

Implementation Science 1/2012 Go to the issue

Research

Insights into the impact and use of research results in a residential long-term care facility: a case study

Methodology

Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework

Systematic review

A systematic review of hand hygiene improvement strategies: a behavioural approach

Research

Chief nursing officers’ perspectives on Medicare’s hospital-acquired conditions non-payment policy: implications for policy design and implementation

Methodology

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

Research

Implementing a stepped-care approach in primary care: results of a qualitative study