Tibial nerve stimulation compared with sham to reduce incontinence in care home residents: ELECTRIC RCT.

BACKGROUND: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents' dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. OBJECTIVE: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. DESIGN: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. SETTING: A total of 37 UK residential and nursing care homes. PARTICIPANTS: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. INTERVENTIONS: Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. MAIN OUTCOME MEASURES: Primary outcome - change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes - number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. RESULTS: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of -5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and -66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants' scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. CONCLUSIONS: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost-consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. LIMITATIONS: Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. FUTURE WORK: Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 41. See the NIHR Journals Library website for further project information.

Bladder leakage (urinary incontinence) is common among people living in care homes. Most people wear absorbent pads to contain urine leakage, but this does not treat the cause of incontinence. Transcutaneous posterior tibial nerve stimulation is a treatment for the type of incontinence associated with a sudden need to use the toilet (urgency incontinence). Two sticky patches applied to the ankle are connected to a small electrical stimulator. The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial looked at whether or not transcutaneous posterior tibial nerve stimulation can help reduce incontinence for people in care homes. A total of 406 residents from 37 care homes were given transcutaneous posterior tibial nerve stimulation treatment or a dummy treatment for 30 minutes, twice per week for 6 weeks. The amount of urine leaked by each resident was measured over 24 hours by collecting all pads used in a sealable plastic bag and weighing the bag. This happened after the final transcutaneous posterior tibial nerve stimulation or dummy treatment, and again after 3 and 5 months. Residents, family members and care home staff were asked if they thought that the transcutaneous posterior tibial nerve stimulation had any effect and for their views of the treatment. We found no important difference in leakage between residents who had the transcutaneous posterior tibial nerve stimulation and those who had the dummy treatment. There were also no differences in daily pad use, feelings about bladder condition or quality of life. It cost around £120 to train staff to deliver transcutaneous posterior tibial nerve stimulation and around £80 per person to have transcutaneous posterior tibial nerve stimulation treatment. Transcutaneous posterior tibial nerve stimulation had no serious side-effects. Care home residents, even those with severe dementia, found the application of transcutaneous posterior tibial nerve stimulation acceptable. Staff found learning about incontinence helpful, but continence care routines did not change. In summary, the ELECTRIC trial found that for very dependent older people in care homes, transcutaneous posterior tibial nerve stimulation did not reduce urinary incontinence. The findings do not support transcutaneous posterior tibial nerve stimulation use to reduce urinary incontinence in care home environments.

Achieving evidence-based nursing practice: impact of the Caledonian Development Model.

AIM: To determine the impact of the Caledonian Development Model, designed to promote evidence-based practice. BACKGROUND: The model features practice-development activities, benchmarking, knowledge pooling and translation through membership of a community of practice and a virtual college. METHODS: Twenty-four nurses, from 18 practice sites formed three communities of practice, each selecting evidence-based guidance to implement. A modified group supervision framework empowered nurses to champion local implementation. Outcomes were determined at 6 months. RESULTS: Eighty per cent of the patient-related criteria and 35% of the facilities criteria were achieved. The Revised Nursing Work Index indicated these nurses experienced greater autonomy (P = 0.019) and increased organizational support (P = 0.037). Focus groups revealed a deepening organizational support for the initiative over time, illuminated work-based learning challenges and overall enthusiasm for the approach. CONCLUSION: Implementation of the model effectively promoted evidence-based practice, most notably at the level of the individual patient. IMPLICATIONS FOR NURSING MANAGEMENT: Time and budgetary constraints necessitate smart, value for money approaches to developing evidence-based practice and improved care standards. This work demonstrates an effective model that strikes a balance between individual and group learning, virtual and real-time activities, coupled with resource pooling across organizations and sectors.

Influence of policies on nursing practice in long-term care environments for older people.

AIM: This paper reports a study exploring nurses' awareness of, access to and use of policies within long-term care environments for older people in Scotland. BACKGROUND: The provision of the highest quality of nursing care for older people with continuing care needs is facilitated through a number of strategic mechanisms. These encompass regulatory systems, national and local policies and care guidance. Failure of practitioners to engage with the 'policy context' may compromise care standards. METHOD: This was a two-stage investigation. A Delphi approach with 33 panel members was used to generate consensus as to the 10 most important current policies in this area of practice. A postal survey was undertaken with 2072 nurses to identify the practice impact of policies, including the 10 identified items. FINDINGS: Identification of the 10 most important policies proved challenging for panel members. Initially they identified 137 policy items, which were reduced after clustering and two further rounds to 10 items (consensus agreement 57%). Completed questionnaires were returned by 986 (48%) nurses. A long list of problems limited access to policy information. Nurses reported little time to keep up to date, compounded by communication inefficiencies and limited access to the internet. Awareness of the 10 selected items ranged from 46 to 83% and clarity of the practice message was high (85-94%); however, the reported influence on practice varied, with 10-26% of respondents indicating no effect. Professional priorities did not coincide with the priorities of older people themselves. CONCLUSION: Nurses appear bewildered by the number and status of policy items. Current methods to provide nurses with information and keep them up to date were not ideal. Processes need to be developed that will engage nurses in policy and pursue closer alignment with the priorities of older people. Strategies are required to identify key policies and promote their implementation.