A randomized controlled trial protocol testing a decision support intervention for older patients with advanced kidney disease

Aim To assess the effectiveness of a decision support intervention using a pragmatic single blind Randomized Controlled Trial. Background Worldwide the proportion of older people (aged 65 years and over) is rising. This population is known to have a higher prevalence of chronic diseases including chronic kidney disease. The resultant effect of the changing health landscape is seen in the increase in older patients (aged ≥65 years) commencing on dialysis. Emerging evidence suggests that for some older patients dialysis may provide minimal benefit. In a majority of renal units non-dialysis management is offered as an alternative to undertaking dialysis. Research regarding decision-making support that is required to assist this population in choosing between dialysis or non-dialysis management is limited. Design. A multisite single blinded pragmatic randomized controlled trial is proposed. Methods Patients will be recruited from four Queensland public hospitals and randomizd into either the control or intervention group. The decision support intervention is multimodal and includes counselling provided by a trained nurse. The comparator is standard decision-making support. The primary outcomes are decisional regret and decisional conflict. Secondary outcomes are improved knowledge and quality of life. Ethics approval obtained November 2014. Conclusion This is one of the first randomized controlled trials assessing a decision support intervention in older people with advance chronic kidney disease. The results may provide guidance for clinicians in future approaches to assist this population in decision-making to ensure reduced decisional regret and decisional conflict.

A randomised controlled clinical trial of a post-discharge, nurse-led educational intervention to reduce anxiety and enhance self-efficacy in percutaneous coronary intervention (PCI) patients within the first week post-discharge: A pilot study

This research investigated the efficacy of a post-discharge nurse-led clinic, for patients who underwent a cardiovascular interventional procedure in Australia. A randomised controlled clinical trial measured the effects of the clinic on patient confidence to self-manage and minimise psychological distress given the strong link between anxiety, depression and coronary heart disease. Hospitalisation for the procedure is short and stressful, and patients may wait up to 7-64 days for post-discharge review. This study provides preliminary quantitative and qualitative evidence that nurse-led clinics undertaken within the first week post-percutaneous coronary intervention may fill a much-needed gap for patients during a potentially vulnerable period.

Women’s Wellness after Cancer Program Study (WWACP)– A multi centre randomised controlled trial examining the benefits and cost effectiveness of an Evidenced Based, e-health intervention

Background Advances in cancer diagnosis and treatment have significantly improved survival rates, through their subsequent health needs are often not adequately addressed by current health services. National Health and Medical Research Council (NHMRC) Partnerships Project awarded a national collaborative project to develop, trial and evaluate clinical benefits and cost effectiveness of an e-health enabled structured health promotion intervention - The Women’s Wellness after Cancer Program (WWACP). The aim of this e-health enabled multimodal intervention is to improve health related quality of life in women previously treated for target cancers. Aim The WWACP is a 12-week web based, interactive, holistic program. Primary outcomes for this project are to promote a positive change in health-related quality of life (HRQoL) and reduction in Body Mass Index (BMI) in the women undertaking WWACP compared to women who receive usual care. Secondary outcomes include managing other side effects of cancer treatment through evidence-based nutrition and exercise practices, dealing with stress, sleep, menopause and sexuality issues. Methods The single-blinded multi-center randomized controlled trial recruited a toatl of 330 women within 24 months of completion of chemotherapy and /or radiotherapy. Women were randomly assigned to either a usual care or intervention group. Women provided with the intervention were provided with an interactive iBook and journal, web interface, and three virtual consultations by experienced cancer nurses. A variety of methods were utilized, to enable positive self- efficacy and lifestyle changes. These include online coaching with a registered nurse trained in the intervention, plus written educational and health promotional information. The program has been delivered through the e-health enabled interfaces, which enables virtual delivery via desktop and mobile computing devices. Importantly this enables accessibility for rural and regional women in Australia who are frequently geographically disadvantaged in terms of health care provision. Results Research focusing on alternative methods of delivering post treatment / or survivorship care in cancer utilizing web based interfaces is limited, but emerging evidence suggests that Internet interventions can increase psychological and physical wellbeing in cancer patients. The WWACP trial aims to establish the effectiveness of delivery of the program in terms of positive patient outcomes and cost effective, flexibility. The trial will be completed in September and results will be presented at the conference. Conclusions Women after acute hematological, breast and gynecological cancer treatments demonstrate good cancer survival rates and face residual health problems which are amenable to behavioral interventions. The conclusion of active treatment is a key 'teachable moment' in which sustainable positive lifestyle change can be achieved if patients receive education and psychological support which targets key treatment related health problems and known chronic disease risk factors.

Evaluating the effectiveness of a self-management exercise intervention on wound healing, functional ability and health-related quality of life outcomes in adults with venous leg ulcers: a randomised controlled trial

Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. The objectives of this research were to assess the impact of an exercise intervention in addition to routine evidence-based care on the healing rates, functional ability and health-related quality of life for adults with venous leg ulcers (VLUs). This study included 63 patients with VLUs. Patients were randomised to receive either a 12-week exercise intervention with a telephone coaching component or usual care plus telephone calls at the same timepoints. The primary outcome evaluated the effectiveness of the intervention in relation to wound healing. The secondary outcomes evaluated physical activity, functional ability and health-related quality of life measures between groups at the end of the 12 weeks. A per protocol analysis complemented the effectiveness (intention-to-treat) analysis to highlight the importance of adherence to an exercise intervention. Intention-to-treat analyses for the primary outcome showed 77% of those in the intervention group healed by 12 weeks compared to 53% of those in the usual care group. Although this difference was not statistically significant due to a smaller than expected sample size, a 24% difference in healing rates could be considered clinically significant. The per protocol analysis for wound healing, however, showed that those in the intervention group who adhered to the exercise protocol 75% or more of the time were significantly more likely to heal and showed higher rates for wound healing than the control group (P = 0·01), that is, 95% of those who adhered in the intervention group healed in 12 weeks. The secondary outcomes of physical activity, functional ability and health-related quality of life were not significantly altered by the intervention. Among the secondary outcomes (physical activity, functional ability and health-related quality of life), intention-to-treat analyses did not support the effectiveness of the intervention. However, per protocol analyses revealed encouraging results with those participants who adhered more than 75% of the time (n = 19) showing significantly improved Range of Ankle Motion from the self-management exercise programme (P = 0·045). This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to standard care are more likely to heal and have better functional outcomes than those who do not adhere to the exercises in conjunction with usual care.

Art and Social Work: an intervention programme for transforming society’s vision to include people with early-onset dementia and Alzheimer’s

This paper presents a program centred on arts and education as tools in social work for the inclusion of people with earlyonset dementia and Alzheimer’s. The objective of the programme is to eradicate the stigma and myths associated with the disease.The program is part of the Junta de Castilla y León and the European Social Fund’s ARS Project (Arte y Salud Alzheimer; Alzheimer’s Art & Health). The programme presents a series of evaluated artistic and educational activities that can be undertaken by people in the early stages of Alzheimer’s disease and that can also be used by caregivers and family when working with this group of people, with the aim of improving their wellbeing, self-esteem and quality of life.

The impact of nurse-directed protocolised-weaning from mechanical ventilation on nursing practice: A quasi-experimental study

Background:
Internationally, nurse-directed protocolised-weaning has been evaluated by measuring its impact on patient outcomes. The impact on nurses’ views and perceptions has been largely ignored.

Aim:
To determine the change in intensive care nurses’ perceptions, satisfaction, knowledge and attitudes following the introduction of nurse-directed weaning. Additionally, views were obtained on how useful protocolised-weaning was to practice.

Methods:
The sample comprised nurses working in general intensive care units in three university-affiliated hospitals. Nurse-directed protocolised-weaning was implemented in one unit (intervention group); two ICUs continued with usual doctor-led practice (control group). Nurses’ perceptions, satisfaction, knowledge and attitudes were measured by self-completed questionnaires before (Phase I) and after the implementation of nurse-directed weaning (Phase II) in all units.

Results:
Response rates were 79% (n=140n=140) for Phase 1 and 62% (n=132n=132) for Phase II. Regression-based analyses showed that changes from Phase I to Phase II were not significantly different between the intervention and control groups. Sixty-nine nurses responded to both Phase I and II questionnaires. In the intervention group, these nurses scored their mean perceived level of knowledge higher in Phase II (6.39 vs 7.17, p=0.01p=0.01). In the control group, role perception (4.41 vs 4.22, p=0.01p=0.01) was lower and, perceived knowledge (6.03 vs 6.63, p=0.04p=0.04), awareness of weaning plans (6.09 vs 7.06, p=0.01p=0.01) and satisfaction with communication (5.28 vs 6.19, p=0.01p=0.01) were higher in Phase II. The intervention group found protocolised weaning useful in their practice (75%): this was scored significantly higher by junior and senior nurses than middle grade nurses (p=0.02p=0.02).

Conclusion

We conclude that nurse-directed protocolised-weaning had no effect on nurses’ views and perceptions due to the high level of satisfaction which encouraged nurses’ participation in weaning throughout. Control group changes are attributed to a ‘reactive effect’ from being study participants. Weaning protocols provide a uniform method of weaning practice and are particularly beneficial in providing safe guidance for junior staff.

The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems

Background: Developing complex interventions for testing in randomised controlled trials is of increasing importance in healthcare planning. There is a need for careful design of interventions for secondary prevention of coronary heart disease (CHD). It has been suggested that integrating qualitative research in the development of a complex intervention may contribute to optimising its design but there is limited evidence of this in practice. This study aims to examine the contribution of qualitative research in developing a complex intervention to improve the provision and uptake of secondary prevention of CHD within primary care in two different healthcare systems.

Methods: In four general practices, one rural and one urban, in Northern Ireland and the Republic of Ireland, patients with CHD were purposively selected. Four focus groups with patients (N = 23) and four with staff (N = 29) informed the development of the intervention by exploring how it could be tailored and integrated with current secondary prevention activities for CHD in the two healthcare settings. Following an exploratory trial the acceptability and feasibility of the intervention were discussed in four focus groups (17 patients) and 10 interviews (staff). The data were analysed using thematic analysis.

Results: Integrating qualitative research into the development of the intervention provided depth of information about the varying impact, between the two healthcare systems, of different funding and administrative arrangements, on their provision of secondary prevention and identified similar barriers of time constraints, training needs and poor patient motivation. The findings also highlighted the importance to patients of stress management, the need for which had been underestimated by the researchers. The qualitative evaluation provided depth of detail not found in evaluation questionnaires. It highlighted how the intervention needed to be more practical by minimising administration, integrating role plays into behaviour change training, providing more practical information about stress management and removing self-monitoring of lifestyle change.

Conclusion: Qualitative research is integral to developing the design detail of a complex intervention and tailoring its components to address individuals' needs in different healthcare systems. The findings highlight how qualitative research may be a valuable component of the preparation for complex interventions and their evaluation.

Development of a Complex Intervention for Secondary Prevention of Coronary Heart Disease in Primary Care Using the UK Medical Research Council Framework

Objective: To apply the UK Medical Research Council (MRC) framework for development and evaluation of trials of complex interventions to a primary healthcare intervention to promote secondary prevention of coronary heart disease. Study Design: Case report of intervention development. Methods: First, literature relating to secondary prevention and lifestyle change was reviewed. Second, a preliminary intervention was modeled, based on literature findings and focus group interviews with patients (n = 23) and staff (n = 29) from 4 general practices. Participants’ experiences of and attitudes toward key intervention components were explored. Third, the preliminary intervention was pilot-tested in 4 general practices. After delivery of the pilot intervention, practitioners evaluated the training sessions, and qualitative data relating to experiences of the intervention were collected using semistructured interviews with staff (n = 10) and patient focus groups (n = 17). Results: Literature review identified 3 intervention components: a structured recall system, practitioner training, and patient information. Initial qualitative data identified variations in recall system design, training requirements (medication prescribing, facilitating behavior change), and information appropriate to the prospective study participants. Identifying detailed structures within intervention components clarified how the intervention could be tailored to individual practice, practitioner, and patient needs while preserving the theoretical functions of the components. Findings from the pilot phase informed further modeling of the intervention, reducing administrative time, increasing practical content of training, and omitting unhelpful patient information. Conclusion: Application of the MRC framework helped to determine the feasibility and development of a complex intervention for primary care research.

A cluster randomised controlled trial to evaluate a policy of making hip protectors available to residents of nursing homes

Objectives: to evaluate the effectiveness of a policy of making hip protectors available to residents of nursing homes. Design: a cluster randomised controlled trial of the policy in nursing and residential homes, with the home as the unit of randomisation. Setting: 127 nursing and residential homes in the greater Belfast area of Northern Ireland. Participants: 40 homes in the intervention group (representing 1,366 occupied beds) and 87 homes in the control group (representing 2,751 occupied beds). Interventions: a policy of making hip protectors available free of charge to residents of nursing homes and supporting the implementation process by employing a nurse facilitator to encourage staff in the homes to promote their use, over a 72-week period. Main outcome measures: the rate of hip fractures in intervention and control homes, and the level of adherence to use of hip protectors. Results: there were 85 hip fractures in the intervention homes and 163 in the control homes. The mean fracture rate per 100 residents was 6.22 in the intervention homes and 5.92 in the control homes, giving an adjusted rate ratio for the intervention group compared to the control group of 1.05 (95% CI 0.77, 1.43, P = 0.76). Initial acceptance of the hip protectors was 37.2% (508/1,366) with adherence falling to 19.9% (272/1,366) at 72 weeks. Conclusions: making hip protectors available to residents of nursing and residential homes did not reduce the rate of hip fracture.

Monitoring treatment fidelity in a randomised controlled trial of a complex intervention.

Aim. This paper is a report of a study to describe how treatment fidelity is being enhanced and monitored, using a model from the National Institutes of Health Behavior Change Consortium. Background. The objective of treatment fidelity is to minimize errors in interpreting research trial outcomes, and to ascribe those outcomes directly to the intervention at hand. Treatment fidelity procedures are included in trials of complex interventions to account for inferences made from study outcomes. Monitoring treatment fidelity can help improve study design, maximize reliability of results, increase statistical power, determine whether theory-based interventions are responsible for observed changes, and inform the research dissemination process. Methods. Treatment fidelity recommendations from the Behavior Change Consortium were applied to the SPHERE study (Secondary Prevention of Heart DiseasE in GeneRal PracticE), a randomized controlled trial of a complex intervention. Procedures to enhance and monitor intervention implementation included standardizing training sessions, observing intervention consultations, structuring patient recall systems, and using written practice and patient care plans. The research nurse plays an important role in monitoring intervention implementation. Findings. Several methods of applying treatment fidelity procedures to monitoring interventions are possible. The procedure used may be determined by availability of appropriate personnel, fiscal constraints, or time limits. Complex interventions are not straightforward and necessitate a monitoring process at trial stage. Conclusion. The Behavior Change Consortium’s model of treatment fidelity is useful for structuring a system to monitor the implementation of a complex intervention, and helps to increase the reliability and validity of evaluation findings.

Does additional support by nurses enhance the effect of a brief smoking cessation intervention in people with moderate to severe chronic obstructive pulmonary disease? A randomised controlled trial

Background: Smoking cessation is the primary disease modifying intervention for chronic obstructive pulmonary disease (COPD).

A Cluster Randomized Controlled Trial of an Adapted U.S. Model of Pharmaceutical Care for Nursing Home Residents in Northern Ireland (Fleetwood Northern Ireland Study): A Cost-Effectiveness Analysis

OBJECTIVES: To evaluate the cost-effectiveness of an adapted U.S. model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in Northern Ireland (Fleetwood NI Study).
DESIGN: Economic evaluation alongside a cluster randomized controlled trial.
SETTING: Nursing homes in NI randomized to intervention (receipt of the adapted model of care; n511) or control (usual care continued; n511).
PARTICIPANTS: Residents aged 65 and older who provided informed consent (N5253; 128 intervention, 125 control) and who had full resource use data at 12 months.
INTERVENTION: Trained pharmacists reviewed intervention home residents’ clinical and prescribing information for 12 months, applied an algorithm that guided them in assessing the appropriateness of psychoactive medication, and worked with prescribers (general practitioners) to make changes. The control homes received usual care in which there was no pharmacist intervention.
MEASUREMENTS: The proportion of residents prescribed one or more inappropriate psychoactive medications (according to standardized protocols), costs, and a cost-effectiveness acceptability curve. The latter two outcomes are the focus for this article.
RESULTS: The proportions of residents receiving inappropriate psychoactive medication at 12 months in the intervention and control group were 19.5% and 50.4%, respectively. The mean cost of healthcare resources used per resident per year was $4,923 (95% con?dence interval.

An evaluation of an adapted United States model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in Northern Ireland (Fleetwood NI Study).

OBJECTIVES: To test the effect of an adapted U.S. model of pharmaceutical care on prescribing of inappropriate psychoactive (anxiolytic, hypnotic, and antipsychotic) medications and falls in nursing homes for older people in Northern Ireland (NI).

DESIGN: Cluster randomized controlled trial.

SETTING: Nursing homes randomized to intervention (receipt of the adapted model of care; n=11) or control (usual care continued; n=11).

PARTICIPANTS: Residents aged 65 and older who provided informed consent (N=334; 173 intervention, 161 control).

INTERVENTION: Specially trained pharmacists visited intervention homes monthly for 12 months and reviewed residents' clinical and prescribing information, applied an algorithm that guided them in assessing the appropriateness of psychoactive medication, and worked with prescribers (general practitioners) to improve the prescribing of these drugs. The control homes received usual care.

MEASUREMENTS: The primary end point was the proportion of residents prescribed one or more inappropriate psychoactive medicine according to standardized protocols; falls were evaluated using routinely collected falls data mandated by the regulatory body for nursing homes in NI.

RESULTS: The proportion of residents taking inappropriate psychoactive medications at 12 months in the intervention homes (25/128, 19.5%) was much lower than in the control homes (62/124, 50.0%) (odds ratio=0.26, 95% confidence interval=0.14–0.49) after adjustment for clustering within homes. No differences were observed at 12 months in the falls rate between the intervention and control groups.

CONCLUSION: Marked reductions in inappropriate psychoactive medication prescribing in residents resulted from pharmacist review of targeted medications, but there was no effect on falls.

Psycho-educational group intervention for family caregivers of hospitalized palliative care patients:pilot study

Family caregivers of patients requiring palliative care commonly experience physical, social, and psychological burdens. Although family caregivers are acknowledged as valid service recipients of palliative care, many have unmet needs, and systematic reviews have shown there are limited evidence-based supportive interventions.