Effect of a national community intervention programme on healing rates of chronic leg ulcer: Randomised controlled trial

Abstract

Background and Objective: Chronic leg ulcer is a common cause of serious disability in the elderly. Healing rates of chronic leg ulcers of 50-75% at 3-6 months have been reported from clinical trials in which specialist nurses delivered the care. But most patients in the population are managed by community nurses in the home, where the results are largely unknown. The aims of this trial were to audit healing rates and to evaluate the effect of a national community-based intervention programme of nurse training. Design: Fifteen Community Healthcare Trusts and one Healthcare Division in 10 Health Board Areas in Scotland comprising a population of 2.65 million took part in a cluster randomised controlled trial in which geographically and administratively distinct localities averaging 53 000 population were randomised, at the time of dissemination of Scottish Intercollegiate (SIGN) guidelines, to a programme of nurse training (intervention) or no training (control). Data were provided by 649 district nurse Case Load Managers (CLMs) via 10 3-monthly censuses (6 months baseline, 21 months post-randomisation). SIGN guidelines were disseminated nationally and in the intervention areas an intensive training course in leg ulcer care and teaching methods was provided for 51 link nurses who cascaded training to community nurses, supported by regional workshops run by the project team. Training was evaluated at each stage. Findings: A total of 4984 ulcerated legs in 3949 patients were registered: 991 (25%) males and 2958 (75%) females, mean age 77 years. Response rates from CLMs were 99.4% at the first census and 100% for all subsequent censuses. Outcome data were obtained for 98.9% of all ulcerated legs entered into the study. Care was provided by 1700 community nurses, each of whom saw an average of 1.5 leg ulcer patients annually. There were 489 deaths and 65 amputations with identical rates between the two groups. The 3-month healing rate was 28% in the intervention and control groups at baseline and did not change in either during the following 2 years. The more chronic the ulcer the lower the healing rate. Interpretation: The 3-month healing rate of less than 30% throughout more than 2 years of study, together with the lack of any evidence of improvement following an intensive guideline-based community intervention programme, indicate that a radical reappraisal is required of how care for patients with chronic leg ulcer should be delivered.