Personal Consultee Research Articles

Proactive and Integrated Management and Empowerment in Parkinson’s Disease protocol for a randomised controlled trial (PRIME-UK) to evaluate a new model of care

BackgroundPeople living with Parkinson’s disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life and can lead to an increased risk of hospitalisation. It is increasingly recognised that the current care models are not suitable for the needs of people with parkinsonism whose care needs evolve and change as the disease progresses. This trial aims to evaluate whether a complex and innovative model of integrated care will increase an individual’s ability to achieve their personal goals, have a positive impact on health and symptom burden and be more cost-effective when compared with usual care.MethodsThis is a single-centre, randomised controlled trial where people with parkinsonism and their informal caregivers are randomised into one of two groups: either PRIME Parkinson multi-component model of care or usual care. Adults ≥18 years with a diagnosis of parkinsonism, able to provide informed consent or the availability of a close friend or relative to act as a personal consultee if capacity to do so is absent and living in the trial geographical area are eligible. Up to three caregivers per patient can also take part, must be ≥18 years, provide informal, unpaid care and able to give informed consent. The primary outcome measure is goal attainment, as measured using the Bangor Goal Setting Interview. The duration of enrolment is 24 months. The total recruitment target is n=214, and the main analyses will be intention to treat.DiscussionThis trial tests whether a novel model of care improves health and disease-related metrics including goal attainment and decreases hospitalisations whilst being more cost-effective than the current usual care. Subject to successful implementation of this intervention within one centre, the PRIME Parkinson model of care could then be evaluated within a cluster-randomised trial at multiple centres.

Needs of patients with parkinsonism and their caregivers: a protocol for the PRIME-UK cross-sectional study

IntroductionPeople with parkinsonism are a highly heterogeneous group and the disease encompasses a spectrum of motor and non-motor symptoms which variably emerge and manifest across the disease course, fluctuate over...

697 PATIENTS WITH PARKINSONISM AND THEIR CAREGIVERS: A PROTOCOL FOR THE PRIME-UK CROSS-SECTIONAL STUDY

Abstract Introduction People with parkinsonism (PwP) are a highly heterogeneous group and the condition encompasses a spectrum of motor and nonmotor symptoms which variably emerge and manifest across the disease course, fluctuate over time and negatively impact quality of life. Whilst parkinsonism is not directly the result of ageing, it is a condition that mostly affects older people, who may also be living with frailty and multimorbidity. This study aims to describe a broad range of PwP in relation to their symptomatology, disability, health needs, disease stage, comorbidities and sociodemographics. Methods In this cross-sectional study, performed at one site, PwP (excluding those with drug-induced parkinsonism) will be sent a study information pack for themselves and their primary informal caregiver, if relevant. Data are collected via questionnaire, with additional support if required to maximise participation. A specific strategy has been developed to target and proactively recruit patients lacking capacity to consent, including those in residential care settings, with input from a personal consultee prior to completion of a bespoke questionnaire by a representative. Caregivers are also recruited to look at various health outcomes. Results Our primary outcome is the frequency of various health outcomes (e.g. depression) and how they cluster together. Linear and logistic regression models will be used to test simple associations and interactions with gender, age group and socio-economic status. Conclusion It is necessary to consider the multifaceted problems that PwP experience, together with frailty and comorbidities, in order to fully appreciate the clinical complexity as well as the impact on caregiver well-being. This information is necessary to inform the development of a person-centered, individualised multicomponent intervention to target patients and caregivers most at risk of adverse outcomes. We hope that these findings will inform future intervention trials and improve accessibility to research participation.

Case Report: The use of advanced consent methodology and healthcare professional consultee to facilitate research participation in dying patients

As the need for palliative care increases, it is essential for research opportunities to be offered to patients with palliative care needs to ensure patients can receive evidence-based treatments and services to improve care. Although it is recognised that palliative, and in particular end of life, research can be both methodically and ethically challenging it is important to note that palliative patients are keen to be involved with research. Over the past three years, patients in Marie Curie Hospice Liverpool have been recruited to a research study evaluating hydration, where advance consent methodology is used to facilitate participation at the end of life. In this study, participants provided ‘advanced consent’ to receive research assessments, in anticipation of the deterioration of their health and loss of the ability to provide consent to ongoing research participation. During this process, recruiting participants will nominate a consultee (who can be any family member, friend or healthcare professional), who is contacted by the researcher prior to completion of research assessments. Participants will generally choose a caregiver or friend to act as a personal consultee; however, there may be some instances where a healthcare professional is chosen. In this, we share our experiences using advanced consent methodology and a healthcare professional acting as a consultee, to facilitate research assessments in a patient who was lacking capacity at the end of life.

Prospective longitudinal observational study of the macro and micro haemodynamic responses to septic shock in the renal and systemic circulations: a protocol for the MICROSHOCK – RENAL study

IntroductionSeptic acute kidney injury (AKI) is the most common complication of septic shock and increases mortality. A large body of experimental data suggests alterations in renal perfusion occur, but this...

MEDREV: feasibility study of a combined pharmacy–health psychology intervention to improve care for people with dementia with behaviour that challenges in care homes

Background‘Behaviour that Challenges’ is common in older people with dementia in care homes and treated with antipsychotics. Policy is focused on reducing the use of antipsychotics in people with dementia and therefore reducing harm. This submission reports results on a NIHR-funded feasibility study MEDREV.AimTo assess the feasibility of medication review by a specialist dementia care pharmacist combined with staff training with the objective of limiting the inappropriate use of psychotropics.MethodCare homes were recruited. People meeting the inclusion (dementia; medication for behaviour that challenges), or their personal consultee, were approached. A specialist dementia care pharmacist reviewed medication and made recommendations. Care staff received a 3-hour training session promoting person-centred care and GPs’ brief training. Data were collected on recruitment and retention, and implementation of recommendations. Other outcomes included the Neuropsychiatric Inventory-Nursing Home version, quality of life (EQ-5D/DEMQoL), cognition (sMMSE), and health economic (CSRI). Qualitative interviews explored expectations and experiences.ResultsMedication reviews were conducted in 29 of 34 residents recruited and the pharmacist recommended reviewing medication in 21 of these. Fifteen (71.4%) of these were antidepressants: 57.1% (12 of 21) of recommendations were implemented and implementation took a mean of 98.4 days. Non-implementation themes for will be presented. One hundred and sixty-four care staff received training (care homes = 142; primary care = 22). Twenty-one participants (care home managers = 5; GPs = 3; nurses = 2; care staff = 11) were interviewed.ConclusionThe study was feasible, although the approach would need modification to improve the uptake of reviews and reduce the delay in implementation. Most of the recommendations related to antidepressants.

Does pre-existing cognitive impairment impact on amount of stroke rehabilitation received? An observational cohort study

Objective: To examine whether stroke survivors in inpatient rehabilitation with pre-existing cognitive impairment receive less therapy than those without. Design: Prospective observational cohort. Setting: Four UK inpatient stroke rehabilitation units. Participants: A total of 139 stroke patients receiving rehabilitation, able to give informed consent/had an individual available to act as personal consultee. In total, 33 participants were categorized with pre-existing cognitive impairment based on routine documentation by clinicians and 106 without. Measures: Number of inpatient therapy sessions received during the first eight weeks post-stroke, referral to early supported discharge, and length of stay. Results: On average, participants with pre-existing cognitive impairment received 40 total physiotherapy and occupational therapy sessions compared to 56 for those without (mean difference = 16.0, 95% confidence interval (CI) = 2.9, 29.2), which was not fully explained by adjusting for potential confounders (age, sex, National Institutes of Health Stroke Scale (NIHSS), and pre-stroke modified Rankin Scale (mRS)). While those with pre-existing cognitive impairment received nine fewer single-discipline physiotherapy sessions (95% CI = 3.7, 14.8), they received similar amounts of single-discipline occupational therapy, psychology, and speech and language therapy; two more non-patient-facing occupational therapy sessions (95% CI = –4.3, –0.6); and nine fewer patient-facing occupational therapy sessions (95% CI = 3.5, 14.9). There was no evidence to suggest they were discharged earlier, but of the 85 participants discharged within eight weeks, 8 (42%) with pre-existing cognitive impairment were referred to early supported discharge compared to 47 (75%) without. Conclusion: People in stroke rehabilitation with pre-existing cognitive impairments receive less therapy than those without, but it remains unknown whether this affects outcomes.

The Endocrine and Metabolic Response in Male Survivors of Major Trauma

Background: Survival rates after severe injury are improving, but complication rates and outcomes are variable. This study addressed the lack of data on the endocrine response, particularly adrenal steroid secretion, during recovery from major trauma, exploring potential targets for intervention. Methods: We undertook a prospective, observational cohort study from time of injury to six months post-injury at a major UK trauma centre and a military rehabilitation unit, studying patients within 24 hours of major trauma (estimated New Injury Severity Score (NISS) >15) and at regular intervals for six months. We recorded clinical outcomes (ventilator days, length of hospital stay, organ dysfunction, sepsis), measured serum steroids by tandem mass spectrometry, and assessed muscle loss by ultrasound and nitrogen excretion. Findings: We screened 996 multiply injured adults, approached 106, and recruited 95 eligible patients; 87 survived. We analysed all male survivors <50 years not treated with steroids (N=60; median age 27 [interquartile range 24-31] years; median NISS 34 [29-44]). Urinary nitrogen excretion and muscle loss peaked after one and six weeks, respectively. Glucocorticoid secretion remained within the reference range, though the serum cortisol over cortisone ratio increased, normalising by eight weeks. Serum testosterone, DHEA and DHEAS decreased immediately after injury and took two, four and more than six months, respectively, to recover; all three correlated with SOFA score and probability of sepsis. Interpretation: The acute catabolic response to severe injury is accompanied by sustained androgen suppression. The impact of androgen supplementation on health outcomes after major trauma should be systematically explored. Funding: The SIR Study was part of the Surgeon General’s Casualty Nutrition Study (SGCNS), supported by University Hospitals Birmingham NHS Foundation Trust (UHB) and the University of Birmingham. Additional funding was provided by the Drummond Trust Foundation. Declaration of Interest: There is no conflict of interests for any of the authors. JML and WA are supported by the National Institute for Health Research (NIHR) through the NIHR Birmingham Biomedical Research Centre. Ethical Approval: Informed consent was obtained from a personal consultee and confirmed subsequently by surviving patients following recovery of capacity. The protocol was approved by the NRES Committee South West – Frenchay 11/SW/0177 and MOD REC 116/Gen/10.

Medication review plus person-centred care: a feasibility study of a pharmacy-health psychology dual intervention to improve care for people living with dementia

Background“Behaviour that Challenges” is common in people living with dementia, resident in care homes and historically has been treated with anti-psychotics. However, such usage is associated with 1800 potentially avoidable deaths annually in the UK. This study investigated the feasibility of a full clinical trial of a specialist dementia care pharmacist medication review combined with a health psychology intervention for care staff to limit the use of psychotropics.This paper focuses on feasibility; including recruitment and retention, implementation of medication change recommendations and the experiences and expectations of care staff.MethodsWest Midlands care homes and individuals meeting the inclusion criteria (dementia diagnosis; medication for behaviour that challenges), or their personal consultee, were approached for consent.A specialist pharmacist reviewed medication. Care home staff received an educational behaviour change intervention in a three-hour session promoting person-centred care. Primary healthcare staff received a modified version of the training.The primary outcome measure was the Neuropsychiatric Inventory-Nursing Home version at 3 months. Other outcomes included quality of life, cognition, health economics and prescribed medication. A qualitative evaluation explored expectations and experiences of care staff.ResultsFive care homes and 34 of 108 eligible residents (31.5%) were recruited, against an original target of 45 residents across 6 care homes. Medication reviews were conducted for 29 study participants (85.3%) and the pharmacist recommended stopping or reviewing medication in 21 cases (72.4%). Of the recommendations made, 57.1% (12 of 21) were implemented, and implementation (discontinuation) took a mean of 98.4 days. In total, 164 care staff received training and 21 were interviewed.Care staff reported a positive experience of the intervention and post intervention adopting a more holistic patient-centred approach.ConclusionsThe intervention contained two elements; staff training and medication review. It was feasible to implement the staff training, and the training appeared to increase the ability and confidence of care staff to manage behaviour that challenges without the need for medication. The medication review would require significant modification for full trial partly related to the relatively limited uptake of the recommendations made, and delay in implementation.Trial registrationISRCTN58330068. Registered 15 October 2017. Retrospectively registered

Improving the management of behaviour that challenges associated with dementia in care homes: protocol for pharmacy–health psychology intervention feasibility study

IntroductionThe inappropriate use of antipsychotics in people with dementia for behaviour that challenges is associated with an estimated 1800 deaths annually. However, solely focusing on antipsychotics may transfer prescribing to...

Observational study of the effects of traumatic injury, haemorrhagic shock and resuscitation on the microcirculation: a protocol for the MICROSHOCK study

IntroductionThe microcirculation is the physiological site of oxygen and substrate exchange. Its effectiveness during circulatory shock is vital for the perfusion of tissues, and has a bearing on subsequent organ...

Can outbreak research be achieved in a population with impaired capacity? Findings from a study of a scabies outbreak in residential care

BackgroundDisease outbreaks in residential care where dementia is prevalent are an important public health concern and challenging to study. To explore the feasibility of outbreak research in a population lacking mental capacity we studied scabies outbreaks in residential care homes for elderly people. MethodsBetween Jan 23, 2014, and April 23, 2015, participants were recruited from ten residential care homes in South East England reporting scabies outbreaks to their local health protection unit. Preliminary visits were organised in advance of clinical visits to assess mental capacity and, when appropriate, seek consent from residents to be recruited and clinically examined. When residents did not have the capacity to consent, advice was sought from a personal consultee (usually next of kin) via telephone and followed up with written confirmation. When a personal consultee could not be contacted or did not exist, advice was sought from a nominated consultee (institution staff). Researchers were trained to assess mental capacity and did so at each visit because capacity often fluctuates in this population. During two clinical visits, residents were fully examined and skin conditions recorded and photographed. When scabies was diagnosed, skin scrapes and blood samples were taken for analysis and stored for future research. The study was approved by Camberwell St Giles NRES Committee (12/LO/0001). FindingsOf 295 residents approached, 144 (49%) were assessed as having capacity to consent and 122 (41%) gave written consent; consultee advice was sought for 151 (51%). All 24 nominated consultees and 117 (92%) of 127 personal consultees advised that they thought the person without capacity would wish to take part. Consent or positive advice was obtained from 264 (89%) of 295 residents for clinical examinations and skin scrapes and from 187 (71%) of 264 residents for photography of skin conditions. Separate consent for storage of tissue and blood samples was introduced partway through and consent or positive advice was obtained for 100 (66%) of 151 residents. 231 (88%) of 264 residents were examined: 155 (67%) had dementia, of whom 54 (35%) were able to give written consent, and differences in the perceived and assessed capacity between care home staff and researchers were noted. 191 (83%) of the 231 participants were examined at both clinical visits. Reasons why 40 residents were not examined at the 6 week follow-up visit included: deceased (13, 33%), respite or re-enablement (10, 25%), unwell or distressed (7, 18%), admission to hospital (5, 13%), unable to schedule appointment (3, 8%), and refused (2, 5%). 12 (6%) of 191 participants experienced fluctuating mental capacity. Clinical visits took place within a median 5 days (IQR 3–8) of notification of the outbreak to the study team. InterpretationPublic health research during outbreaks in residential care is complex but achievable. It requires substantial resource and training to deliver rapid and repeated assessment of mental capacity and obtain timely consultee advice in line with the Mental Capacity Act 2005. FundingPublic Health England and the British Skin Foundation.

Is the Mental Capacity Act reducing generalizable research in care homes?

* Corresponding author. Tel.: þ44 08454 2250 E-mail address: Gemma.Lasseter@hpa.or 0033-3506/$ e see front matter a 2011 The R doi:10.1016/j.puhe.2011.04.007 The National Dementia Strategy in 2009 called for an increased coordinated research programme (Objective 16), while a collaborative report from the Royal College of Physicians, Royal College of Nursing and the British Geriatric Society called for more research in care homes. Currently in the UK, £11 is spent on research for each individual with dementia, compared with around £300 for each cancer patient. A European Charter has been launched recently to highlight the rights and importance of recruiting older people into research trials. Section 30 of the Mental Capacity Act states that subjects without decisional capacity (including dementia) should only be recruited into research trials if their inclusion is essential. A ‘personal consultee’ must give informed consent on their behalf, and the subject themselves must demonstrate agreement in cooperating with the researcher. In practice, this process is problematic, illustrated by the authors’ experience below. The recognition of dementia by staff in long-term care is low, and there is no reliable objective method of defining who lacks decisional capacity. Consultees may not appreciate that their relative lacks decisional capacity and can be