Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU).

INTRODUCTION: Compression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise. METHODS AND ANALYSIS: The Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective. ETHICS AND DISSEMINATION: The Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page. TRIAL REGISTRATION NUMBERS: Australia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).

How active are patients in setting goals during rehabilitation after stroke? A qualitative study of clinician perceptions.

PURPOSE: We investigated stroke rehabilitation clinician's perceptions of the patient as an active partner in setting goals within stroke rehabilitation and factors that influence patient engagement. METHODS: Semi-structured interviews, subject to general inductive analysis with 20 Clinicians' working in three UK based stroke rehabilitation teams (one in-patient ward and two community based rehabilitation teams). RESULTS: There were three key themes that impacted on the patients active involvement in setting goals for rehabilitation after stroke: Patient barriers to goal setting (knowledge of the patient and family, who is the patient and the stroke's impact); How we work as a team (the role of the patient in setting goals, the effect of clinician attributes on goal setting); and How systems impact goal setting (goal-setting practice, home versus hospital, and professional/funder expectations of clinicians'). CONCLUSIONS: Goal setting served a range of different, sometimes conflicting, functions within rehabilitation. Clinicians' identified the integral nature of goals to engage and motivate patients and to provide direction and purpose for rehabilitation. Further, there was an identified need to consider the impact of prioritizing clinician-derived goals at the expense of patient-identified goals. Lastly the reliance on the SMART goal format requires further consideration, both in terms of the proposed benefits and whether they disempower the patient during rehabilitation. Implications for rehabilitation Goal setting is often promoted as a relatively simple, straightforward way to structure interactions with patients Patient-related factors together with resourcing constraints are significant barriers to patient-centered goal setting, particularly during inpatient rehabilitation Clinicians need to have pragmatic tools that can be integrated into practice to ensure that goal-setting practice can be maximized for patients with different intrinsic characteristics.

The effect of a designated tool on person-centred goal identification and service planning among older people receiving homecare in New Zealand.

This study sought to determine the ability of a designated tool developed to identify client-directed goals in a sample of older people referred for homecare. A retrospective pre/post-intervention design was used and a total of 360 older people in an urban centre in New Zealand were included in the analysis. All clients receiving services at the time of data collection (July 2007) who were referred for service provision between July 2003 and the implementation in January 2007 of a restorative model of homecare were included in the analysis. The restorative model of homecare included a designated goal-facilitation tool [Towards Achieving Realistic Goal in Elders Tool (TARGET)]. Prior to the use of TARGET, participants had a goal recorded for their home-care episode in 31 cases (8.6%), whereas following the implementation of TARGET, goals were recorded in 339 cases (94.2%). At a quarterly review, eight clients (2.2%) achieved their goal prior to TARGET, whereas 172 clients (47.8%) fully achieved their goal when TARGET was utilised. Within the sample, multinomial logistic regression showed that the use of TARGET significantly improved goal attainment. Furthermore, moderate-to-severe cognitive impairment significantly reduced the successful attainment of goals. The study highlighted the importance of a designated tool for facilitating older people to set goals that are then used in developing support plans to structure services to assist them in the home. The need for alternative strategies for goal setting for people with significant cognitive impairment was highlighted. This study, in attempting to determine the effect of a goal-facilitation tool as a driver for quality improvement in homecare, had an observational comparative design, this being the most pragmatic option to assess the feasibility of TARGET prior to further work being undertaken. The results do show that in this sample of older people receiving homecare, the use of TARGET led to a greater proportion of goal identification, higher rates of goal attainment and a more diverse range of categories of goals than traditional non-structured methods of goal setting.