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A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial.

ABSTRACT: Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS).In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded.Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p?=?0.020]. The MuIS was cost-saving £-93.20 (£406.51 vs. £499.71 per patient) after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p?=?0.004]).Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines.ClinicalTrials.gov, NCT01699256.

SUBMITTER: Riis A

PROVIDER: S-EPMC5073468 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial.

Riis Allan A Jensen Cathrine Elgaard CE Bro Flemming F Maindal Helle Terkildsen HT Petersen Karin Dam KD Bendtsen Mette Dahl MD Jensen Martin Bach MB

Implementation science : IS 20161021 1

<h4>Background</h4>Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS).<h4>Methods</h4>In a cluster r ...[more]

PMID: 27769263

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Project description:BackgroundFew patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral.MethodsA cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the softwareResultsFrom 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261) had significant pathology, compared with 19% (49/253) in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15). In the combined educational outreach arms 15% (38/258) had significant pathology compared with 19% (48/256) in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24). Pro forma practices documented better assessment of patients at referral.ConclusionThere was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of lessons were learned in this trial of novel innovations.

Project description:INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN012606000098538.

Project description:ObjectivesTo assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients' back pain beliefs, and in decreasing disability and absenteeism.DesignStepped-wedge cluster randomised trial with parallel economic evaluation.SettingDutch primary healthcare.ParticipantsPatients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).InterventionsThe intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.Primary and secondary outcome measuresThe primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.ResultsThere were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70- and the societal cost difference was €535-in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).ConclusionsA multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.Trial registration numberNTR4329.

Project description:BackgroundFor the optimal use of clinical guidelines in daily practice, mere distribution of guidelines and materials is not enough, and active implementation is needed. This review investigated the effectiveness of multifaceted implementation strategies compared to minimal, single, or no implementation strategy for the implementation of non-specific low back and/or neck pain guidelines in health care.MethodsThe following electronic databases were searched from inception to June 1, 2015: MEDLINE, Embase, PsycInfo, the Cochrane Library, and CINAHL. The search strategy was restricted to low back pain, neck pain, and implementation research. Studies were included if their design was a randomized controlled trial, reporting on patients (age ≥18 years) with non-specific low back pain or neck pain (with or without radiating pain). Trials were eligible if they reported patient outcomes, measures of healthcare professional behaviour, and/or outcomes on healthcare level. The primary outcome was professional behaviour. Guidelines that were evaluated in the studies had to be implemented in a healthcare setting. No language restrictions were applied, and studies had to be published full-text in peer-reviewed journals, thus excluding abstract only publications, conference abstracts, and dissertation articles. Two researchers independently screened titles and abstract, extracted data from included studies, and performed risk of bias assessments.ResultsAfter removal of duplicates, the search resulted in 4750 abstracts to be screened. Of 43 full-text articles assessed for eligibility, 12 were included in this review, reporting on 9 individual studies, and separate cost-effectiveness analyses of 3 included studies. Implementation strategies varied between studies. Meta-analyses did not reveal any differences in effect between multifaceted strategies and controls.ConclusionThis review showed that multifaceted strategies for the implementation of neck and/or back pain guidelines in health care do not significantly improve professional behaviour outcomes. No effects on patient outcomes or cost of care could be found. More research is necessary to determine whether multifaceted implementation strategies are conducted as planned and whether these strategies are effective in changing professional behaviour and thereby clinical practice.

Project description:BackgroundEvidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.AimThis study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.Methods/designThis study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.

Project description:BackgroundThe Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline) was published in 2019. The objective of this trial is to implement the Guideline in general practice.Trial designImplementing work-related Mental health conditions in general PRacticE is a hybrid III, parallel cluster randomised controlled trial undertaken in Australia. Its primary aim is to assess the effectiveness of a complex intervention on the implementation of the Guideline in general practice. Secondary aims are to assess patient health and work outcomes, to evaluate the cost-effectiveness of the trial, and to develop a plan for sustainability.MethodsA total of 86 GP clusters will be randomly allocated either to the intervention arm, where they will receive a complex intervention comprising academic detailing, enrolment in a community of practice and resources, or to the control arm, where they will not receive the intervention. GP guideline concordance will be assessed at baseline and 9 months using virtual simulated patient scenarios. Patients who meet the eligibility criteria (>18years, employed, and receiving care from a participating GP for a suspected or confirmed work-related mental health condition) will be invited to complete surveys about their health and work participation and provide access to their health service use data. Data on health service use and work participation compensation claim data will be combined with measures of guideline concordance and patient outcomes to inform an economic evaluation. A realist evaluation will be conducted to inform the development of a plan for sustainability.ResultsWe anticipate that GPs who receive the intervention will have higher guideline concordance than GPs in the control group. We also anticipate that higher concordance will translate to better health and return-to-work outcomes for patients, as well as cost-savings to society.ConclusionsThe trial builds on a body of work defining the role of GPs in compensable injury, exploring their concerns, and developing evidence-based guidelines to address them. Implementation of these guidelines has the potential to deliver improvements in GP care, patient health, and return-to-work outcomes.Trial registrationACTRN12620001163998 , November 2020.

Project description:BackgroundColorectal cancer is a common malignancy and a leading cause of cancer-related death. Half of patients with colorectal cancer initially present with non-specific or vague symptoms. In the need for a safe low-cost test, the immunochemical faecal occult blood test (iFOBT) may be part of the evaluation of such patients in primary care. Currently, Danish general practitioners have limited access to this test. The aim of this article is to describe a study that will assess the uptake and clinical use of iFOBT in general practice. Furthermore, it will investigate the diagnostic value and the clinical implications of using iFOBT in general practice on patients presenting with non-alarm symptoms of colorectal cancer.Methods/designThe study uses a cluster-randomised stepped-wedge design and is conducted in the Central Denmark Region among 836 GPs in 381 general practices. The municipalities of the Region and their appertaining general practitioners will be included sequentially in the study during the first 7 months of the 1-year study period. The following intervention has been developed for the study: a mandatory intervention providing all general practitioners with a starting package of 10 iFOBTs, a clinical instruction on iFOBT use in general practice and online information material from the date of inclusion, and an optional intervention consisting of a continuous medical education on colorectal cancer diagnostics and use of iFOBT.DiscussionThis study is among the first and largest trials to investigate the diagnostic use and the clinical value of iFOBT on patients presenting with non-alarm symptoms of colorectal cancer. The findings will be of national and international importance for the future planning of colorectal cancer diagnostics, particularly for 'low-risk-but-not-no-risk' patients with non-alarm symptoms of colorectal cancer.Trial registrationA Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.

Project description:BackgroundEffective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world's most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control).Methods and findingsThis pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI -0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices.ConclusionsFindings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP.Trial registrationACTRN12616000888460.

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A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial.

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A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial.

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