Cardiometabolic health nursing to improve health and primary care access in community mental health consumers: Protocol for a randomised controlled trial

Background

People with a serious mental illness are at significantly greater risk of poor cardiometabolic health with recent studies showing a greater than two-fold increase in the risk of obesity, infectious diseases, diabetes and cardiovascular disease. Contributing factors to this disparity include poorer health behaviours such as suboptimal physical activity, poor diet, smoking, alcohol and illicit drug misuse. In particular, the limited access to primary health care experienced by people with a serious mental illness has been highlighted. Persons with a serious mental illness are around 30% less likely than those without serious mental illness to receive health assessments, hospital admissions or procedures for cardiovascular disease and diabetes, and are less likely to undergo cancer screening or receive vaccinations. Studies show that mental health consumers may be more likely to use mental health services rather than primary care for contact with the health care system. However mental health nurses report several barriers to their capacity to provide cardiometabolic health care crucial for the treatment of people with a serious mental illness.

Objectives

To assess the impact of a specialist Cardiometabolic Health Nurse on the physical health care of community based mental health consumers.

Setting

Community mental health facility in a large regional centre in Central Queensland, Australia.

Design/methods

Community based mental health consumers will be randomised to receive either usual care, or consultations with a Cardiometabolic Health Nurse. The Cardiometabolic Health Nurse will be responsible for assessing the client and coordinating cardiometabolic health care as required. Post intervention review of health records will be performed with the primary outcome measure being self-reported physical health. Secondary outcomes include the utilisation of primary care services and changes in health behaviours. We hypothesise that the Cardiometabolic Health Nurse will increase the utilisation of health care services for mental health consumers.

Results

Data collection commenced in March 2013 and will conclude September 2013. Preliminary finding are expected in December 2013.     

Writing to patients: a randomised controlled trial

It has been suggested that consultants should consider writing directly to patients with a summary of their outpatient consultation. In a controlled trial involving consecutive new referrals to a haematology outpatient clinic, we randomised patients to receive either a personal letter from their consultant summarising their consultation (n = 77) or a brief note thanking them for attending the clinic (n = 73). Patients were assessed for recall of and satisfaction with the consultation by a single independent observer, using standardised methods. At the second visit to outpatients, the patients' median percentage recall of items discussed during the consultation was 67% (IQ range 50-80%) in the intervention group, versus 57% (IQ range 43-76%) in the control group (p = 0.3). Strongly positive views on the personal letter were expressed by patients and referring clinicians. The findings suggest that although personal letters do not substantially improve recall of the clinical encounter, they are feasible, highly valued by patients and acceptable to referring clinicians.     

Home care nursing in Japan: a challenge for providing good care at home

Home care in Japan has developed over the past 30 years. Nurses have taken leadership in promoting home care and at the same time have expanded their roles. The roles of Japanese nurses in the field of home care are presented in the context of the historical perspective and view for the future. Home care nurses have performed care management for their community as well as for individual older clients living in their community. Currently, nurses work as high-tech and personal care providers and are developing a new role in health care enterprises. The number of nurses working as clinical nurse specialists will increase consistently with the rapid increase of master's programs. In the future, nurses should take a lead in developing health policy. The purpose of the article is to describe the current situation of home care clients and home care nursing in Japan. In addition, four issues of home care in Japan are described related to home care for older persons, high-tech home care, terminal care, and home care for psychiatric patients.     

IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care

Background

Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high.

Aim

To assess whether a medication strategy using a fixed dose combination pill (‘polypill’) could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12 months.

Methods

IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572).     

Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care

Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room. Eligible and consenting patients will then complete the DST assessment and are randomised and stratified according to predicted symptom severity. Participants allocated to the intervention arm will receive feedback on DST responses, select treatment priorities, assess motivation to change, and receive a severity-matched treatment recommendation (information about and links to low intensity services for those with mild symptoms, or assistance from a specially trained health professional (care navigator) for those with severe symptoms). All patients allocated to the comparison arm will receive usual GP care plus attention control. Primary (psychological distress) and secondary (depression, anxiety, quality of life, days out of role) outcomes will be assessed at 6 and 12 months. Differences in outcome means between trial arms both across and within symptom severity group will be examined using intention-to-treat analyses. Within trial and modelled economic evaluations will be conducted to determine the value for money of credentials of Link-me. Findings will be reported to the Federal Government to inform how mental health services across Australia are funded and delivered in the future.     

The SHED-IT Weight Loss Maintenance trial protocol: A randomised controlled trial of a weight loss maintenance program for overweight and obese men

Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study will test the effectiveness and cost-effectiveness of a male-only weight loss maintenance intervention. In Phase I (3 months) 209 men received the SHED-IT Weight Loss Program. In Phase II (12 months) 92 men who lost 4 kg or more were randomised to either (i) a maintenance group who received the 6-month, gender-tailored SHED-IT Weight Loss Maintenance Program, which included no face-to-face contact (n = 47), or (ii) a self-help control group (n = 45). Randomisation was stratified by weight loss (4 kg–7.4 kg, ≥ 7.5 kg) and BMI (< 30 kg/m², ≥ 30 kg/m²). Assessments occurred at 'study entry' (start of Phase I), 'baseline' (start of Phase II), '6 months' (post-test) and will occur at '12 months' (follow-up; primary endpoint). The primary outcome is weight change in Phase II (i.e. from 'baseline' at 12 months after randomization). Secondary outcomes include waist circumference (umbilicus and narrowest), blood pressure, body composition, objectively measured physical activity, sedentary time, portion size, dietary intake, quality of life, depressive symptoms, and behavioural cognitions. Costing data will be collected for cost-effectiveness analysis. Generalised linear mixed models (intention-to-treat) will assess outcomes for treatment (maintenance vs. control), time (baseline, 6-month and 12-month) and the treatment-by-time interaction. This will be the first study to evaluate a male-only, gender-targeted weight loss maintenance program. Results will provide evidence regarding feasible and theoretically-driven obesity treatments for men with potential for long-term impact and widespread dissemination.Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12612000749808).     

Depression Care for Patients at Home (Depression CAREPATH): home care depression care management protocol, part 2

High levels of depressive symptoms are common and contribute to poorer clinical outcomes even in geriatric patients who are already taking antidepressant medication. The Depression CARE for PATients at Home (Depression CAREPATH) intervention was designed to meet the needs of medical and surgical patients who suffer from depression. The intervention's clinical protocols are designed to guide clinicians in managing depression as part of routine home care.     

Acupuncture as a complex intervention for depression: a consensus method to develop a standardised treatment protocol for a randomised controlled trial

OBJECTIVE: To standardise a complex intervention by defining the characteristic (specific) components of treatment for a randomised controlled trial of acupuncture as an intervention for individuals who have been diagnosed with depression using a consensus method. METHODS: A nominal group technique was used. Potential components of the acupuncture intervention were generated from the literature, experts and participants. These were categorised as constant or variable, the latter including active management techniques (such as providing relevant explanations), auxiliary techniques (such as auricular acupuncture), and other aspects of patient care (such as offering life-style and dietary advice), all of which were underpinned by defined theoretical frameworks. Participants were selected on the basis of their experience and training, to encompass a diverse range of styles of traditional acupuncture practice in the UK, and all rated components in two rounds. RESULTS: Fifteen practitioners rated 52 variable components in the first round and 55 in the second. There was group support for 16 active management components, three auxiliary techniques and five areas of life-style support, all driven by eight theoretical diagnostic and treatment frameworks. For the 39 components that were rated twice, group support increased between rounds from 75 to 79% (z=-2.2, p=0.03), while the absolute average deviation from the median dropped from 1.04 to 0.83 (z=-2.5, p=0.011). CONCLUSION: Standardising the characteristic components of a complex intervention for a randomised controlled trial of acupuncture for depression using a consensus approach is feasible. The method can be generalised to other clinical situations and other treatment modalities.     

Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: the CoBalT randomised controlled trial protocol

BackgroundAntidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care.Methods/designCoBalT is a two parallel group multi-centre pragmatic RCT. Eligible participants were those who: (i) were aged 18–75 years; (ii) were currently taking antidepressant medication (for at least 6 weeks at an adequate dose); (iii) scored ≥ 14 on the Beck Depression Inventory (BDI-II); (iv) had adhered to their medication; and (v) met ICD-10 criteria for depression (assessed using the Clinical Interview Schedule — revised version). Those who gave written informed consent were randomised to one of two treatment groups: usual care or usual care plus CBT. The primary outcome is depressive symptoms assessed using the BDI-II at 6 months post-randomisation. Secondary outcomes measured at 6 and 12 months include quality of life, antidepressant use and health care utilisation. Outcomes will be analysed on an intention-to-treat basis.DiscussionThe CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to ‘talking therapies’, the results of this study will be timely.     

A randomized controlled trial of a hospital at home service for the terminally ill

This study evaluated the impact of a Cambridge hospital at home service (CHAH) on patients' quality of care, likelihood of remaining at home in their final 2 weeks of life and general practitioner (GP) visits. The design was a randomized controlled trial, comparing CHAH with standard care. The patient's district nurse, GP and informal carer were surveyed within 6 weeks of patient's death, and 225 district nurses, 194 GPs and 144 informal carers of 229 patients responded. There was no clear evidence that CHAH increased likelihood of remaining at home during the final 2 weeks of life. However, the service was associated with fewer GP out of hours visits. All respondent groups rated CHAH favourably compared to standard care but emphasized different aspects. District nurses rated CHAH as better than standard care in terms of adequacy of night care and support for the carer, GPs in terms of anxiety and depression, and informal carers in terms of control of pain and nausea. Thus whilst CHAH was not found to increase the likelihood of remaining at home, at appeared to be associated with better quality home care.     

A controlled clinical trial of home care management versus hospital care management for preterm labour

Prenatal hospitalisation has not been shown to reduce perinatal morbidity and mortality, yet it is still the treatment of choice for women who experience preterm labour. Home care management may be an alternative means of delivering safe, efficacious and care for these women. The objectives of this controlled clinical trial were to examine differences in neonate's gestational age and birthweight, and antenatal stress, social support satisfaction, and family functioning among pregnant women receiving home care and those receiving hospital care management. Pregnant women experiencing preterm labour (N=250) were randomly assigned to home care management (the experimental group [EG]) or hospital care management (the control group [CG]). A Perinatal Information Form was used to collect data on sociodemographic and pregnancy variables. The High-Risk Pregnancy Stress Scale, Brown's Social Behaviors Inventory, and the Family Assessment Measure III Dyadic Relationships Scale were administered to the women at randomisation (T1) and at 1-week (T2) and 2-weeks (T3) after randomisation. Gestational age and birthweight were similar in the two groups of neonates. Women in the EG reported that antenatal stress was significantly lower at T3 than at T1 and T2, while for those in the CG, antenatal stress was significantly lower at T3 than at T1, and significantly lower at T2 than at T1. Women in the EG were more satisfied with support from the male partner at T3 than women in the CG. There was no significant difference between the two groups in family functioning at T1, T2 and T3. These findings indicate that home care management is a safe and efficacious mode of health care delivery for women experiencing preterm labour.     

Delirium in intensive care: A stepped-wedge cluster randomised controlled trial for a nurse-led intervention to reduce the incidence and duration of delirium among adults admitted to the intensive care unit (protocol)

BackgroundDelirium is an acute disorder of attention and cognition with the highest rates among adults receiving intensive care. An acute episode of delirium is associated with morbidity and mortality, as well as a significant psychological sequela. Importantly, an increasing body of evidence supports the benefit of nonpharmacological, nurse-led interventions to reduce the incidence and duration of delirium among adults cared for in the intensive care unit (ICU).ObjectivesThis study will evaluate the impact of a nursing-led delirium prevention protocol that is aimed at reducing the incidence and duration of delirium among adults admitted to the ICU. The delirium prevention nursing protocol specifically targets risk factors for delirium.Study planA stepped-wedge cluster randomised controlled trial approach will be used to assess the effectiveness of the nurse-led intervention, in four adult ICUs across the South Western Sydney Local Health District (SWS-LHD), over a 12-month period. The primary outcomes of interest are (i) the incidence of delirium before and after the implementation of the nurse-led intervention and (ii) the number of delirium-free days during an ICU stay, before and after the implementation of the nurse-led intervention.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): (ACTRN12618000411246p)