Electronic Laboratory Medicine ordering with evidence-based Order sets in primary care (ELMO study): protocol for a cluster randomised trial

Background

Laboratory testing is an important clinical act with a valuable role in screening, diagnosis, management and monitoring of diseases or therapies. However, inappropriate laboratory test ordering is frequent, burdening health care spending and negatively influencing quality of care. Inappropriate tests may also result in false-positive results and potentially cause excessive downstream activities. Clinical decision support systems (CDSSs) have shown promising results to influence the test-ordering behaviour of physicians and to improve appropriateness. Order sets, a form of CDSS where a limited set of evidence-based tests are proposed for a series of indications, integrated in a computerised physician order entry (CPOE) have been shown to be effective in reducing the volume of ordered laboratory tests but convincing evidence that they influence appropriateness is lacking. The aim of this study is to evaluate the effect of order sets on the quality and quantity of laboratory test orders by physicians. We also aim to evaluate the effect of order sets on diagnostic error and explore the effect on downstream or cascade activities.

Methods

We will conduct a cluster randomised controlled trial in Belgian primary care practices. The study is powered to measure two outcomes. We will primarily measure the influence of our CDSS on the appropriateness of laboratory test ordering. Additionally, we will also measure the influence on diagnostic error. We will also explore the effects of our intervention on cascade activities due to altered results of inappropriate tests.

Discussion

We have designed a study that should be able to demonstrate whether the CDSS aimed at diagnostic testing is not only able to influence appropriateness but also safe with respect to diagnostic error. These findings will influence a lager, nationwide implementation of this CDSS.

Trial registration

ClinicalTrials.gov, NCT02950142.

     

Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

ABSTRACT: BACKGROUND: Chronic headache (headache [GREATER-THAN OR EQUAL TO] 15 days/month for at least 3 months) affects 2--5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH) can be identified by using the Severity of Dependence Scale (SDS). A "brief intervention" scheme (BI) has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI) scheme to be used for MOH in primary care. METHODS: A double-blinded cluster randomised parallel controlled trial (RCT) of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. DISCUSSION: There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication withdrawal method. To our knowledge this is the first RCT of structured non-pharmacological MOH treatment in primary care. Results may hold the potential of offering an instrument for treating MOH patients in the general population by GPs. Trial registration ClinicalTrials.gov identifier: NCT01314768.     

Single and dual task gait training in people with Parkinson's Disease: A protocol for a randomised controlled trial

Background  

Difficulty performing more than one task at a time (dual tasking) is a common and disabling problem experienced by people with Parkinson disease (PD). If asked to perform another task when walking, people with PD often take shorter steps or walk more slowly. Currently there is uncertainty about whether clinicians should teach people with PD to avoid dual tasking or whether they should encourage them to practice dual tasking with the hope that practice will lead to enhanced performance. This study will address this issue by comparing single to dual task gait training.     

Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial

Background

Palpitations and pre-syncope are together responsible for 300,000 annual Emergency Department (ED) attendances in the United Kingdom (UK). Diagnosis of the underlying rhythm is difficult as many patients are fully recovered on ED arrival; and examination and presenting electrocardiogram (ECG) are commonly normal. The only way to establish the underlying heart rhythm is to capture an ECG during symptoms. Recent technology advances have led to several novel ECG monitoring devices appearing on the market. This trial aims to compare the symptomatic rhythm detection rate at 90?days of one such smart phone-based event recorder (AliveCor Heart Monitor and AliveECG) with standard care for participants presenting to the ED with palpitations and pre-syncope and no obvious cause in the ED.

Methods/Design

This is a multi-centre hospital ED / Acute Medical Unit (AMU) open label, randomised controlled trial. Participants will be recruited in 10 tertiary and district general hospitals in the UK. Participants aged ≥?16?years presenting with an episode of palpitations or pre-syncope with no obvious cause and whose underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment will be included. Participants will be randomised to either: (1) the intervention arm, standard care plus the use of a smart phone-based event recorder; or (2) the control arm, standard care. Primary endpoint will be symptomatic rhythm detection rate at 90?days. A number of secondary clinical, process and cost-effectiveness endpoints will be collected and analysed. Analysis will be on an intention-to-treat basis.

Discussion

The Investigation of Palpitations in the ED (IPED) study aims to recruit 242 participants across 10 hospital sites. It will be the first study to investigate the ability of a smart phone-based event recorder to detect symptomatic cardiac rhythms compared to standard care for ED patients with palpitations and pre-syncope with no obvious cause in the ED. This smart phone event recorder will allow ED patients who have presented with palpitations or pre-syncope to record their ECG tracing if they have a further episode and may increase the rate of underlying rhythm diagnosis.

Trial registration

ClinicalTrials.gov, NCT02783898. Registered on 26 May 2016.

     

Improving the health behaviours of elderly people: randomised controlled trial of a general practice education programme

ObjectivesTo establish the effect of an educational intervention for general practitioners on the health behaviours and wellbeing of elderly patients.DesignRandomised controlled trial with 1 year follow up.SettingMetropolitan general practices in Melbourne, Australia.Subjects42 general practitioners and 267 of their patients aged over 65 years.InterventionEducational and clinical practice audit programme for general practitioners on health promotion for elderly people.ResultsPatients in the intervention group had increased (a) walking by an average of 88 minutes per fortnight, (b) frequency of pleasurable activities, and (c) self rated health compared with the control group. No change was seen in drug usage, rate of influenza vaccination, functional status, or psychological wellbeing as a result of the intervention. Extrapolations of the known effect of these changes in behaviour suggest mortality could be reduced by 22% if activity was sustained for 5 years.ConclusionsEducation of the general practitioners had a positive effect on health outcomes of their elderly patients. General practitioners may have considerable public health impact in promotion of health for elderly patients.

Key messages

• Few educational interventions for doctors have shown benefit to the health of patients
• Elderly people were identified in the UK health initiatives as in need of additional attention, and levels of health protective behaviours were low in community surveys
• A multifaceted educational intervention for general practitioners was effective in improving walking behaviour, self rated health status, and the frequency of social contacts in elderly patients
• General practitioners are effective in improving health and health behaviours in their elderly patients

     

A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol

Background

Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, “Step it Up” will compare the effect of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS.

Methods/design

People with a diagnosis of MS who walk independently, score of 0–3 on the Patient Determined Disease Steps, who have not experienced an MS relapse or change in their MS medication in the last 12 weeks and who are physically inactive will be randomised to one of two study conditions. The experimental group will undergo a 10-week exercise plus SCT-based behavioural change intervention. The control group will undergo a 10-week exercise plus education intervention to control for contact. Participants will be assessed at weeks 1, 12, 24 and 36. The primary outcome will be walking mobility. Secondary outcomes will include: aerobic capacity, lower extremity muscle strength, participant adherence to the exercise programme, self-report exercise intensity, self-report enjoyment of exercise, exercise self-efficacy, outcome expectations for exercise, goal-setting for exercise, perceived benefits and barriers to exercise, perceptions of social support, physical and psychological impact of MS and fatigue. A qualitative evaluation of Step it Up will be completed among participants post-intervention.

Discussion

This randomised controlled trial will examine the effectiveness of an exercise plus SCT-based behaviour change intervention on walking mobility among people with MS. To this end, Step it Up will serve to inform future directions of research and clinical practice with regard to sustainable exercise interventions for people with MS.

Trial registration

ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02301442

     

The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

Background

Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting.

Methods/Design

This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012.

Discussion

The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis.

Trial registration

ClinicalTrials.gov: NCT01057173     

Exercise therapy for prevention of falls in people with Parkinson's disease: A protocol for a randomised controlled trial and economic evaluation

Background

People with Parkinson's disease are twice as likely to be recurrent fallers compared to other older people. As these falls have devastating consequences, there is an urgent need to identify and test innovative interventions with the potential to reduce falls in people with Parkinson's disease. The main objective of this randomised controlled trial is to determine whether fall rates can be reduced in people with Parkinson's disease using exercise targeting three potentially remediable risk factors for falls (reduced balance, reduced leg muscle strength and freezing of gait). In addition we will establish the cost effectiveness of the exercise program from the health provider's perspective.

Methods/Design

230 community-dwelling participants with idiopathic Parkinson's disease will be recruited. Eligible participants will also have a history of falls or be identified as being at risk of falls on assessment. Participants will be randomly allocated to a usual-care control group or an intervention group which will undertake weight-bearing balance and strengthening exercises and use cueing strategies to address freezing of gait. The intervention group will choose between the home-based or support group-based mode of the program. Participants in both groups will receive standardized falls prevention advice. The primary outcome measure will be fall rates. Participants will record falls and medical interventions in a diary for the duration of the 6-month intervention period. Secondary measures include the Parkinson's Disease Falls Risk Score, maximal leg muscle strength, standing balance, the Short Physical Performance Battery, freezing of gait, health and well being, habitual physical activity and positive and negative affect schedule.

Discussion

No adequately powered studies have investigated exercise interventions aimed at reducing falls in people with Parkinson's disease. This trial will determine the effectiveness of the exercise intervention in reducing falls and its cost effectiveness. This pragmatic program, if found to be effective, has the potential to be implemented within existing community services.

Trial registration

The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000303347).     

Nutritional treatment of aged individuals with Alzheimer's disease living at home with their spouses: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Nutritional status often deteriorates in Alzheimer's disease (AD). Less is known about whether nutritional care reverses malnutrition and its harmful consequences in AD. The aim of this study is to examine whether individualized nutritional care has an effect on weight, nutrition, health, physical functioning, and quality of life in older individuals with AD and their spouses living at home. METHODS: AD patients and their spouses (aged >65 years) living at home (n = 204, 102 AD patients) were recruited using central AD registers in Finland. The couples were randomized into intervention and control groups. A trained nutritionist visited intervention couples four to eight times at their homes and the couples received tailored nutritional care. When necessary, the couples were given protein and nutrient-enriched complementary drinks. All intervention couples were advised to take vitamin D 20 mug/day. The intervention lasted for 1 year. The couples of the control group received a written guide on nutrition of older people. Participants in the intervention group were assessed every 3 months. The primary outcome measure is weight change. Secondary measures are the intake of energy, protein, and other nutrients, nutritional status, cognition, caregiver's burden, depression, health-related quality of life, and grip strength. DISCUSSION: This study provides data on whether tailored nutritional care is beneficial to home-dwelling AD patients and their spouses. Trial registration ACTRN 12611000018910.     

A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care homes (OTCH): study protocol

ABSTRACT: BACKGROUND: The occupational therapy (OT) in care homes study (OTCH) aims to investigate the effect of a targeted course of individual OT (with task training, provision of adaptive equipment, minor environmental adaptations and staff education) for stroke survivors living in care homes, compared to usual care. METHODS/DESIGN: A cluster randomised controlled trial of United Kingdom (UK) care homes (n?=?90) with residents (n?=?900) who have suffered a stroke or transient ischaemic attack (TIA), and who are not receiving end-of-life care. Homes will be stratified by centre and by type of care provided and randomised (50:50) using computer generated blocked randomisation within strata to receive either the OT intervention (3 months intervention from an occupational therapist) or control (usual care). Staff training on facilitating independence and mobility and the use of adaptive equipment, will be delivered to every home, with control homes receiving this after the 12 month follow-up.Allocation will be concealed from the independent assessors, but the treating therapists, and residents will not be masked to the intervention. Measurements are taken at baseline prior to randomisation and at 3, 6 and 12 months post randomisation. The primary outcome measure is independence in self-care activities of daily living (Barthel Activities of Daily Living Index). Secondary outcome measures are mobility (Rivermead Mobility Index), mood (Geriatric Depression Scale), preference based quality of life measured from EQ-5D and costs associated with each intervention group. Quality adjusted life years (QALYs) will be derived based on the EQ-5D scores. Cost effectiveness analysis will be estimated and measured by incremental cost effectiveness ratio. Adverse events will be recorded. DISCUSSION: This study will be the largest cluster randomised controlled trial of OT in care homes to date and will clarify the currently inconclusive literature on the efficacy of OT for stroke and TIA survivors residing in care homes. TRIAL REGISTRATION: ISRCTN00757750.     

Home based care and standard hospital care for patients with severe mental illness: a randomised controlled trial.

OBJECTIVE--To compare the efficacy of home based care with standard hospital care in treating serious mental illness. DESIGN--Randomised controlled trial. SETTING--South Southwark, London. PATIENTS--189 patients aged 18-64 living in catchment area. 92 were randomised to home based care (daily living programme) and 97 to standard hospital care. At three months'' follow up 68 home care and 60 hospital patients were evaluated. MAIN OUTCOME MEASURES--Use of hospital beds, psychiatric diagnosis, social functioning, patients'' and relatives'' satisfaction, and activity of daily living programme staff. RESULTS--Home care reduced hospital stay by 80% (median stay six days in home care group, 53 days in hospital group) and did not increase the number of admissions compared with hospital care. On clinical and social outcome there was a non-significant trend in favour of home care, but both groups showed big improvements. On the global adjustment scale home care patients improved by 26.8 points and the hospital group by 21.6 points (difference 5.2; 95% confidence interval -1.5 to 12). Other rating scales showed similar trends. Home care patients required a wide range of support in areas such as housing, finance, and work. Only three patients dropped out from the programme. CONCLUSIONS--Home based care may offer some slight advantages over hospital based care for patients with serious mental illness and their relatives. The care is intensive, but the low drop out rate suggests appreciation. Changes to traditional training for mental health workers are required.     

Effects of multidisciplinary integrated care on quality of care in residential care facilities for elderly people: a cluster randomized trial

Background:

Sophisticated approaches are needed to improve the quality of care for elderly people living in residential care facilities. We determined the effects of multidisciplinary integrated care on the quality of care and quality of life for elderly people in residential care facilities.

Methods:

We performed a cluster randomized controlled trial involving 10 residential care facilities in the Netherlands that included 340 participating residents with physical or cognitive disabilities. Five of the facilities applied multidisciplinary integrated care, and five provided usual care. The intervention, inspired by the disease management model, consisted of a geriatric assessment of functional health every three months. The assessment included use of the Long-term Care Facility version of the Resident Assessment Instrument by trained nurse-assistants to guide the design of an individualized care plan; discussion of outcomes and care priorities with the family physician, the resident and his or her family; and monthly multidisciplinary meetings with the nurse-assistant, family physician, psychologist and geriatrician to discuss residents with complex needs. The primary outcome was the sum score of 32 risk-adjusted quality-of-care indicators.

Results:

Compared with the facilities that provided usual care, the intervention facilities had a significantly higher sum score of the 32 quality-of-care indicators (mean difference − 6.7, p = 0.009; a medium effect size of 0.72). They also had significantly higher scores for 11 of the 32 indicators of good care in the areas of communication, delirium, behaviour, continence, pain and use of antipsychotic agents.

Interpretation:

Multidisciplinary integrated care resulted in improved quality of care for elderly people in residential care facilities compared with usual care.

Trial registration:

www.controlled-trials.com trial register no. ISRCTN11076857.The quality of care provided in residential care facilities is under pressure worldwide.¹ Facilities are frequently understaffed, and the complexity of care needed by residents increases while expertise of staff does not necessarily keep pace.^2,3 Although most care organizations want to innovate and improve quality of care, many lack expertise or financial resources needed to do so.^4,5 Family physicians are responsible for medical care in residential care facilities in the Netherlands. However, they do not regard themselves as suited for systematic management of chronic diseases and disabilities associated with frail health.⁶About 10% of elderly people aged 75 or older in the Netherlands live in residential care facilities.^7,8 These facilities were established to offer sheltered living for elderly people who are disabled but still relatively healthy. Because of the growing elderly population, the characteristics of elderly people living in residential care facilities have become more comparable to those of people in nursing homes, who need complex care. Residential care facilities in the Netherlands are comparable to residential care facilities in Canada, are publicly funded and are subject to government inspection and approval. Over 70% of the residents need professional care, such as assistance with activities of daily living, nursing care (e.g., medication, wound care) and housekeeping. They have multiple chronic diseases and associated disabilities.^9–12Effective interventions for chronic illnesses generally rely on a multidisciplinary team approach. The elements of this approach include structured geriatric assessment, protocol-based regulation of medications, support for self-reliance and intensive follow-up. The closely related disease management model comprises coordination of care, steering of the care process and patient empowerment.¹³ This model is strongly recommended by Bodenheimer and colleagues to improve the health and quality of life of chronically ill patients.¹⁴ However, no studies have as yet been undertaken to evaluate the effects of disease management on functional health and quality of care for elderly people in residential care facilities who have physical or cognitive disabilities.We developed an approach to multidisciplinary integrated care inspired by the disease management model. The objective of our study was to determine the effects of multidisciplinary integrated care on quality of care and quality of life for elderly people in residential care facilities.     

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial

Background

Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8–12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model.

Methods/design

A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants’ treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER).

Discussion

The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care.

Trial registration

ClinicalTrials.gov NCT02333656