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A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial.

ABSTRACT: Elderly patients with depression are underdiagnosed, undertreated and run a high risk of a chronic course. General practitioners adhere to clinical practice guidelines to a limited degree. In the international research project Tailored Implementation for Chronic Diseases, we tested the effectiveness of tailored interventions to improve care for patients with chronic diseases. In Norway, we examined this approach to improve adherence to six guideline recommendations for elderly patients with depression targeting healthcare professionals, patients and administrators.We conducted a cluster randomised trial in 80 Norwegian municipalities. We identified determinants of practice for six recommendations and subsequently tailored interventions to address these determinants. The interventions targeted healthcare professionals, administrators and patients and consisted of outreach visits, a website presenting the recommendations and the underlying evidence, tools to manage depression in the elderly and other web-based resources, including a continuous medical education course for general practitioners. The primary outcome was mean adherence to the recommendations. Secondary outcomes were improvement in depression symptoms as measured by patients and general practitioners. We offered outreach visits to all general practitioners and practice staff in the intervention municipalities. We used electronic software that extracted eligible patients from the general practitioners' lists. We collected data by interviewing general practitioners or sending them a questionnaire about their practice for four patients on their list and by sending a questionnaire to the patients.One hundred twenty-four of the 900 general practitioners (14 %) participated in the data collection, 51 in the intervention group and 73 in the control group. We interviewed 77 general practitioners, 47 general practitioners completed the questionnaire, and 134 patients responded to the questionnaire. Amongst the general practitioners who provided data, adherence to the recommendations was 1.6 percentage points higher in the intervention group than in the control group (95 % CI -6 to 9).The effectiveness of our tailored intervention to implement recommendations for elderly patients with depression in primary care is uncertain, due to the low response rate in the data collection. However, it is unlikely that the effect was large. It remains uncertain how best to improve adherence to evidence-based recommendations and thereby improve the quality of care for these patients.ClinicalTrials.gov: NCT01913236 .

SUBMITTER: Aakhus E

PROVIDER: S-EPMC4784300 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial.

Aakhus Eivind E Granlund Ingeborg I Odgaard-Jensen Jan J Oxman Andrew D AD Flottorp Signe A SA

Implementation science : IS 20160309

<h4>Background</h4>Elderly patients with depression are underdiagnosed, undertreated and run a high risk of a chronic course. General practitioners adhere to clinical practice guidelines to a limited degree. In the international research project Tailored Implementation for Chronic Diseases, we tested the effectiveness of tailored interventions to improve care for patients with chronic diseases. In Norway, we examined this approach to improve adherence to six guideline recommendations for elderly ...[more]

PMID: 26956726

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Project description:The prevalence of depression is high and the elderly have an increased risk of developing chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health-care professionals adhere to these recommendations to a limited degree only. We conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. We identified and prioritised the determinants of practice related to the implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored interventions for the six recommendations for the management of elderly patients with depression in primary care.We will conduct a pragmatic cluster randomised trial comparing the implementation of the six recommendations using tailored interventions with usual care. We will randomise 80 municipalities into one of two groups: an intervention group, to which we will deliver tailored interventions to implement the six recommendations, and a control group, to which we will not deliver any intervention. We will randomise municipalities rather than patients, individual clinicians or practices, because we will deliver the intervention for the first three recommendations at the municipal level and we want to minimise the risk of contamination across GP practices for the other three recommendations. The primary outcome is the proportion of actions taken by GPs that are consistent with the recommendations.This trial will investigate whether a tailored implementation approach is an effective strategy for improving collaborative care in the municipalities and health-care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.ClinicalTrials.gov: NCT01913236.

Project description:BackgroundSelf-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents.Methods/designThis study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months.DiscussionThis study is designed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy. If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective, it may serve as a basis for optimising the clinical pathway for those suffering from the condition, where specific emphasis can be placed on early diagnosis and early treatment.Trial registrationclinicaltrials.gov reference: NCT01438762.

Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:ObjectivesThis study sought to assess the effectiveness and return on investment (ROI) of a multifaceted intervention aimed at improving antibiotic prescribing for acute respiratory infections in primary care.DesignLarge-sized, two-arm, open-label, pragmatic, cluster-randomised controlled trial.SettingAll primary care physicians working for the Spanish National Health Service (NHS) in Galicia (region in north-west Spain).ParticipantsThe seven spatial clusters were distributed by unequal randomisation (3:4) of the intervention and control groups. A total of 1217 physicians (1.30 million patients) were recruited from intervention clusters and 1393 physicians (1.46 million patients) from control clusters.InterventionsOne-hour educational outreach visits tailored to training needs identified in a previous study; an online course integrated in practice accreditation; and a clinical decision support system.Main outcome measuresChanges in the ESAC (European Surveillance of Antimicrobial Consumption) quality indicators for outpatient antibiotic use. We used generalised linear mixed and conducted a ROI analysis to ascertain the overall cost savings.ResultsMedian follow-up was 19 months. The adjusted effect on overall antibiotic prescribing attributable to the intervention was - 4.2% (95% CI: - 5.3% to - 3.2%), with this being more pronounced for penicillins - 6.5 (95% CI: - 7.9% to - 5.2%) and for the ratio of consumption of broad- to narrow-spectrum penicillins, cephalosporins, and macrolides - 9.0% (95% CI: - 14.0 to - 4.1%). The cost of the intervention was €87 per physician. Direct savings per physician attributable to the reduction in antibiotic prescriptions was €311 for the NHS and €573 for patient contributions, with an ROI of €2.57 and €5.59 respectively.ConclusionsInterventions designed on the basis of gaps in physicians' knowledge of and attitudes to misprescription can improve antibiotic prescribing and yield important direct cost savings.Trial registrationCurrent Controlled Trials ISRCTN24158380 . Registered 5 February 2009.

Project description:BackgroundDepression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes.MethodsWe did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ?32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277.FindingsCare homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI -0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI -0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group.InterpretationThis moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required.FundingNational Institute for Health Research Health Technology Assessment.

Project description:BACKGROUND:People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. METHODS:We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8?weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6?months; participants will be followed up to 12?months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. DISCUSSION:The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. TRIAL REGISTRATION:ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Project description:BackgroundAcute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors' and physiotherapists' adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective.MethodsPhysiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months).ResultsA total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI - 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI - 0.48, 1.21, scale 0-24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74).ConclusionsIntervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009.

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A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial.

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A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial.

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