A randomised controlled trial to assess the impact of a package comprising a patient-orientated, evidence-based self-help guidebook and patient-centred consultations on disease management and satisfaction in inflammatory bowel disease

A Kennedy, E Nelson, D Reeves, G Richardson, C Roberts, A Robinson, A Rogers, M Sculpher, D Thompson
Health Technology Assessment: HTA 2003, 7 (28): iii, 1-113

OBJECTIVES: To determine if a whole systems approach to self-management improves clinical outcomes and leads to cost-effective use of NHS services.

DESIGN: Nineteen hospitals were randomised to 10 control sites and nine intervention sites. Consultants from intervention sites received training in patient-centred care before recruitment and introduced the intervention to eligible patients. Patients at the control sites were recruited and went on to have an ordinary consultation. Qualitative interviews were undertaken to obtain an in-depth understanding of patients' and consultants' experience of the intervention.

SETTING: Follow-up outpatient clinics at 19 hospitals in the north-west of England.

PARTICIPANTS: Seven hundred patients (297 at intervention sites and 403 at control sites) with established ulcerative colitis or Crohn's disease, aged 16 years and over, and able to write in English.

INTERVENTIONS: Consultants were trained to provide a patient-centred approach to care. Guidebooks on ulcerative colitis and Crohn's disease were developed with patients prior to the study. Patients prepared a written self-management plan and self-referred to services based on a self-evaluation of their need for advice.

MAIN OUTCOME MEASURES: Rates of hospital outpatient consultation, quality of life (QoL) and acceptability to patients. Health service resource use and assessed cost effectiveness using the EQ-5D.

RESULTS: After 1 year, the intervention resulted in fewer hospital visits, without change in the number of primary care visits. Patients felt more able to cope with their condition. The intervention produced no reduction in QoL and did not raise anxiety. The intervention group reported fewer symptom relapses; 74% of patients in the intervention group indicated a preference to continue the system. Qualitative results showed the guidebook was effective but organisational limitations constrained patient-centred aspects of the intervention for some. Cost-effectiveness analyses favoured self-management over standard care.

CONCLUSIONS: Further use of this method in chronic disease management seems likely to improve overall patient satisfaction and reduce health expenditure without evidence of adverse effect on disease control. Further attention needs to be given to self-referral and access arrangements and a re-distribution of control to patients through increased adherence to patient-centred norms on the part of consultants. Future research is recommended to evaluate the operating systems within secondary and primary care that would allow self-managers to self-refer and to keep them informed of new treatments, also to explore models for training health professionals in self-care methods, to study long-term effects of self-management in chronic disease and to transfer this approach to other chronic conditions.

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