Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study.

BACKGROUND: The Affordable Care Act encourages healthcare systems to integrate behavioral and medical healthcare, as well as to employ electronic health records (EHRs) for health information exchange and quality improvement. Pragmatic research paradigms that employ EHRs in research are needed to produce clinical evidence in real-world medical settings for informing learning healthcare systems. Adults with comorbid diabetes and substance use disorders (SUDs) tend to use costly inpatient treatments; however, there is a lack of empirical data on implementing behavioral healthcare to reduce health risk in adults with high-risk diabetes. Given the complexity of high-risk patients' medical problems and the cost of conducting randomized trials, a feasibility project is warranted to guide practical study designs. METHODS: We describe the study design, which explores the feasibility of implementing substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults with high-risk type 2 diabetes mellitus (T2DM) within a home-based primary care setting. Our study includes the development of an integrated EHR datamart to identify eligible patients and collect diabetes healthcare data, and the use of a geographic health information system to understand the social context in patients' communities. Analysis will examine recruitment, proportion of patients receiving brief intervention and/or referrals, substance use, SUD treatment use, diabetes outcomes, and retention. DISCUSSION: By capitalizing on an existing T2DM project that uses home-based primary care, our study results will provide timely clinical information to inform the designs and implementation of future SBIRT studies among adults with multiple medical conditions.

Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials.

BACKGROUND: Incorporation of multiple enrichment biomarkers into prospective clinical trials is an active area of investigation, but the factors that determine clinical trial enrollment following a molecular prescreening program have not been assessed. PATIENTS AND METHODS: Patients with 5-fluorouracil-refractory metastatic colorectal cancer at the MD Anderson Cancer Center were offered screening in the Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC) program to identify eligibility for companion phase I or II clinical trials with a therapy targeted to an aberration detected in the patient, based on testing by immunohistochemistry, targeted gene sequencing panels, and CpG island methylation phenotype assays. RESULTS: Between August 2010 and December 2013, 484 patients were enrolled, 458 (95%) had a biomarker result, and 157 (32%) were enrolled on a clinical trial (92 on biomarker-selected and 65 on nonbiomarker selected). Of the 458 patients with a biomarker result, enrollment on biomarker-selected clinical trials was ninefold higher for predefined ATTACC-companion clinical trials as opposed to nonpredefined biomarker-selected clinical trials, 17.9% versus 2%, P < 0.001. Factors that correlated positively with trial enrollment in multivariate analysis were higher performance status, older age, lack of standard of care therapy, established patient at MD Anderson, and the presence of an eligible biomarker for an ATTACC-companion study. Early molecular screening did result in a higher rate of patients with remaining standard of care therapy enrolling on ATTACC-companion clinical trials, 45.1%, in contrast to nonpredefined clinical trials, 22.7%; odds ratio 3.1, P = 0.002. CONCLUSIONS: Though early molecular prescreening for predefined clinical trials resulted in an increase rate of trial enrollment of nonrefractory patients, the majority of patients enrolled on clinical trials were refractory to standard of care therapy. Within molecular prescreening programs, tailoring screening for preidentified and open clinical trials, temporally linking screening to treatment and optimizing both patient and physician engagement are efforts likely to improve enrollment on biomarker-selected clinical trials. CLINICAL TRIALS NUMBER: The study NCT number is NCT01196130.

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.

The SPHERE Study: Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]

Background: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland.CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines.

Methods: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.

Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

Background Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers’ and participants’ experiences of its implementation and to inform future strategies to maximise recruitment and retention. Methods In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. Results We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners’ contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Conclusions Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.

Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial

Objective: To test the effectiveness of a complex intervention designed, within a theoretical framework, to improve outcomes for patients with coronary heart disease. Design: Cluster randomised controlled multicentre trial. Setting: General practices in Northern Ireland and the Republic of Ireland, regions with different healthcare systems. Participants: 903 patients with established coronary heart disease registered with one of 48 practices. Intervention: Tailored care plans for practices (practice based training in prescribing and behaviour change, administrative support, quarterly newsletter), and tailored care plans for patients (motivational interviewing, goal identification, and target setting for lifestyle change) with reviews every four months at the practices. Control practices provided usual care. Main outcome measures: The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration, and those admitted to hospital, and changes in physical and mental health status (SF-12). Results: At baseline the numbers (proportions) of patients above the recommended limits were: systolic blood pressure greater than 140 mm Hg (305/899; 33.9%, 95% confidence interval 30.8% to 33.9%), diastolic blood pressure greater than 90 mm Hg (111/901; 12.3%, 10.2% to 14.5%), and total cholesterol concentration greater than 5 mmol/l (188/860; 20.8%, 19.1% to 24.6%). At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers (proportions) of patients above the recommended limits: systolic blood pressure, intervention 98/360 (27.2%) v control, 133/405 (32.8%), odds ratio 1.51 (95% confidence interval 0.99 to 2.30; P=0.06); diastolic blood pressure, intervention 32/360 (8.9%) v control, 40/405 (9.9%), 1.40 (0.75 to 2.64; P=0.29); and total cholesterol concentration, intervention 52/342 (15.2%) v control, 64/391 (16.4%), 1.13 (0.63 to 2.03; P=0.65). The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group: 107/415 (25.8%) v 148/435 (34.0%), 1.56 (1.53 to 2.60; P=0.03). Conclusions: Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease, but no other clinical benefits were shown, possibly because of a ceiling effect related to improved management of the disease. Trial registration: Current Controlled Trials ISRCTN24081411.

Outreach and Early Warning Systems (EWS) for the prevention of intensive care admission and death of critically ill adult patients on general hospital wards

BACKGROUND: Despite the fact that outreach and early warning systems (EWS) are an integral part of a hospital wide systems approach to improve the early identification and management of deteriorating patients on general hospital wards, the widespread implementation of these interventions in practice is not based on robust research evidence. OBJECTIVES: The primary objective was to determine the impact of critical care outreach services on hospital mortality rates. Secondary objectives included determining the effect of outreach services on intensive care unit (ICU) admission patterns, length of hospital stay and adverse events. SEARCH STRATEGY: The review authors searched the following electronic databases: EPOC Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) and other Cochrane databases (all on The Cochrane Library 2006, Issue 3), MEDLINE (1996-June week 3 2006), EMBASE (1974-week 26 2006), CINAHL (1982-July week 5 2006), First Search (1992-2005) and CAB Health (1990-July 2006); also reference lists of relevant articles, conference abstracts, and made contact with experts and critical care organisations for further information. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series designs (ITS) which measured hospital mortality, unanticipated ICU admissions, ICU readmissions, length of hospital stay and adverse events following implementation of outreach and EWS in a general hospital ward to identify deteriorating adult patients versus general hospital ward setting without outreach and EWS were included in the review. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data and two review authors assessed the methodological quality of the included studies. Meta-analysis was not possible due to heterogeneity. Summary statistics and descriptive summaries of primary and secondary outcomes are presented for each study. MAIN RESULTS: Two cluster-randomised control trials were included: one randomised at hospital level (23 hospitals in Australia) and one at ward level (16 wards in the UK). The primary outcome in the Australian trial (a composite score comprising incidence of unexpected cardiac arrests, unexpected deaths and unplanned ICU admissions) showed no statistical significant difference between control and medical emergency team (MET) hospitals (adjusted P value 0.640; adjusted odds ratio (OR) 0.98; 95% confidence interval (CI) 0.83 to 1.16). The UK-based trial found that outreach reduced in-hospital mortality (adjusted OR 0.52; 95% CI 0.32 to 0.85) compared with the control group. AUTHORS' CONCLUSIONS: The evidence from this review highlights the diversity and poor methodological quality of most studies investigating outreach. The results of the two included studies showed either no evidence of the effectiveness of outreach or a reduction in overall mortality in patients receiving outreach. The lack of evidence on outreach requires further multi-site RCT's to determine potential effectiveness.

Treatment Foster Care for Improving Outcomes in Children and Young People: A Systematic Review

Objective: To assess the impact of treatment foster care (TFC) on psychosocial and behavioral outcomes, delinquency, placement stability, and discharge status for children and adolescents who, for reasons of severe medical, social, psychological and behavioural problems, were placed in out-of-home care in restrictive settings or at risk of placement in such settings. Method: Electronic bibliographic databases, web searches, and article reference lists were used to identify randomized controlled trials (RCTs) investigating the effectiveness of TFC with children and young people. The Cochrane Collaboration’s criteria were used to assess the methodological quality of studies that met the inclusion criteria. Wherever possible, extracted outcome data from similar studies were synthesized with random effects meta-analyses. Results: A total of 5 studies including 390 participants were included in this review. Data suggest that TFC may be a useful intervention for children and young people with complex emotional, psychological, and behavioural need, who are at risk of placements in nonfamily settings that restrict their liberty and opportunities for social inclusion. Conclusion: Although the inclusion criteria for this systematic review set a study design threshold higher than that of previous reviews, the findings mirror those of earlier reviews. While the results of individual studies generally indicate that TFC is a promising intervention for children and youth experiencing mental health problems, behavioral problems, or problems of delinquency, the evidence base is not robust and more research is needed due to the limited number of studies in this area.

The Paediatric Rheumatology International Trials Organisation provisional criteria for the evaluation of response to therapy in juvenile dermatomyositis.

Objective To develop a provisional definition for the evaluation of response to therapy in juvenile dermatomyositis (DM) based on the Paediatric Rheumatology International Trials Organisation juvenile DM core set of variables. Methods Thirty-seven experienced pediatric rheumatologists from 27 countries achieved consensus on 128 difficult patient profiles as clinically improved or not improved using a stepwise approach (patient's rating, statistical analysis, definition selection). Using the physicians' consensus ratings as the “gold standard measure,” chi-square, sensitivity, specificity, false-positive and-negative rates, area under the receiver operating characteristic curve, and kappa agreement for candidate definitions of improvement were calculated. Definitions with kappa values >0.8 were multiplied by the face validity score to select the top definitions. Results The top definition of improvement was at least 20% improvement from baseline in 3 of 6 core set variables with no more than 1 of the remaining worsening by more than 30%, which cannot be muscle strength. The second-highest scoring definition was at least 20% improvement from baseline in 3 of 6 core set variables with no more than 2 of the remaining worsening by more than 25%, which cannot be muscle strength (definition P1 selected by the International Myositis Assessment and Clinical Studies group). The third is similar to the second with the maximum amount of worsening set to 30%. This indicates convergent validity of the process. Conclusion We propose a provisional data-driven definition of improvement that reflects well the consensus rating of experienced clinicians, which incorporates clinically meaningful change in core set variables in a composite end point for the evaluation of global response to therapy in juvenile DM.

Children’s views on unlicensed/off-label paediatric prescribing and paediatric clinical trials.

Objectives: To explore the views and perspectives of children on the unlicensed/off-label use of medicines in children and on the participation of children in clinical trials. Methods: Focus-group discussions, involving school children, were carried out in a range of primary and secondary schools in Northern Ireland. A purposeful sample was chosen to facilitate representation of various socioeconomic groupings. Results: A total of 123 pupils, aged from 10 to 16 years, from six schools, participated in 16 focus groups. In general, pupils viewed the unlicensed/off-label use of medicines in children as unsafe and unethical and felt it is necessary to test medicines in children to improve the availability of licensed products. The majority felt that older children should be told, and that parents should be told, about the unlicensed/off-label use of medicines in children, yet they recognised some implications of this, such as potential medication non-adherence. Conclusions: This is the first study to explore the views of healthy children on unlicensed medicine use in children. Children were able to recognise potential risks associated with the unlicensed use of medicines and felt it is necessary to test and license more medicines in children. Practice implications Health care professionals should consider the views of children in decisions that affect their health.

Treatment Foster Care for improving outcomes in children and young people (Review)

Background: Treatment foster care (TFC) is a foster family-based intervention that aims to provide young people (and, where appropriate, their families) with a tailored programme designed to effect positive changes in their lives. TFC was designed specifically to cater for the needs of children whose difficulties or circumstances place them at risk of multiple placements and/or more restrictive placements such as hospital or secure residential or youth justice settings.

Objectives: To assess the impact of TFC on psychosocial and behavioural outcomes, delinquency, placement stability, and discharge status for children and adolescents who require out-of-home placement.

Search methods: We searched the Cochrane Controlled Trials Register (CENTRAL) 2006 (Issue 4), MEDLINE (1966 to January 2007), CINAHL (1982 to December 2006), PsycINFO (1872 to January 2007), ASSIA (1987 to January 2007), LILACS (1982 to January 2007), ERIC (1966 to January 2007), Sociological Abstracts (1963 to January 2007), and the National Research Register 2006 (Issue 4).

Selection criteria: Included studies were randomised controlled trials investigating the effectiveness of TFC with children and young people up to the age of 18 who, for reasons of severe medical, social, psychological and behavioural problems, were placed in out of home care in restrictive settings (e.g. secure residential care, psychiatric hospital) or at risk of placement in such settings.

Data collection and analysis: Titles and abstracts identified in the search were independently assessed for eligibility by the two authors (GM and WT) who also extracted and entered into REVMAN. Date were synthesised on the few occasions where this was possible. Results are presented in tabular, graphical (forest plots) and textual form.

Main results: Five studies including 390 participants were included in this review. Data suggest that treatment foster care may be a useful intervention for children and young people with complex emotional, psychological and behavioural need, who are at risk of placements in nonfamily settings that restrict their liberty and opportunities for social inclusion.

Authors’ conclusions: Although the inclusion criteria for this systematic review set a study design threshold higher than that of previous reviews, the results mirror those of earlier reviews but also highlights the tendency of the perceived effectiveness of popular interventions to outstrip their evidence base. Whilst the results of individual studies generally indicate that TFC is a promising intervention for children and youth experiencing mental health problems, behavioural problems or problems of delinquency, the evidence base is less robust than that usually reported.The Cochrane Database of Systematic Reviews is a peer reviewed, international journal, published electronically each month. The 2010 Inpact Factor for the Cochrane Database of Systematic Reviews was 6.185.The CDSR is now ranked in the top 10 of the 151 in the Medicine, General & Internal category.

Effect of preventive primary care outreach on health related quality of life among older adults at risk of functional decline: Randomised controlled trial

Objective: To evaluate the impact of a provider initiated primary care outreach intervention compared with usual care among older adults at risk of functional decline. Design: Randomised controlled trial. Setting: Patients enrolled with 35 family physicians in five primary care networks in Hamilton, Ontario, Canada. Participants Patients: were eligible if they were 75 years of age or older and were not receiving home care services. Of 3166 potentially eligible patients, 2662 (84%) completed the validated postal questionnaire used to determine risk of functional decline. Of 1724 patients who met the risk criteria, 769 (45%) agreed to participate and 719 were randomised. Intervention: The 12 month intervention, provided by experienced home care nurses in 2004-6, consisted of a comprehensive initial assessment using the resident assessment instrument for home care; collaborative care planning with patients, their families, and family physicians; health promotion; and referral to community health and social support services. Main outcome measures: Quality adjusted life years (QALYs), use and costs of health and social services, functional status, self rated health, and mortality. Results: The mean difference in QALYs between intervention and control patients during the study period was not statistically significant (0.017, 95% confidence interval -0.022 to 0.056; P=0.388). The mean difference in overall cost of prescription drugs and services between the intervention and control groups was not statistically significant, (-$C165 (£107; €118; $162), 95% confidence interval -$C16 545 to $C16 214; P=0.984). Changes over 12 months in functional status and self rated health were not significantly different between the intervention and control groups. Ten patients died in each group. Conclusions: The results of this study do not support adoption of this preventive primary care intervention for this target population of high risk older adults. Trial registration: Clinical trials NCT00134836.