scholarly journals Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e014576 ◽  
Author(s):  
Paul Wallace ◽  
Pierliugi Struzzo ◽  
Roberto Della Vedova ◽  
Francesca Scafuri ◽  
Costanza Tersar ◽  
...  
Keyword(s):  
Primary Care ◽  
Computer Literacy ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Risky Drinking ◽  
Face To Face ◽  
Audit Score ◽  
Registration Number ◽  
Randomised Controlled ◽  
Alcohol Reduction

BackgroundBrief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown.MethodsPrimary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires.Findings58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19·9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ≥8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary.InterpretationPrespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures.Trial registration numberNCT01638338; Results.

scholarly journals Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Stephanie S. Leone ◽  
Suzanne Lokman ◽  
Brigitte Boon ◽  
Agnes van der Poel ◽  
Filip Smit ◽  
...  
Keyword(s):  
Primary Care ◽  
Implementation Strategy ◽  
Controlled Trial ◽  
Participation Rate ◽  
Cluster Randomised Controlled Trial ◽  
Lower Socioeconomic Status ◽  
Face To Face ◽  
Cluster Randomised ◽  
Lower Socioeconomic ◽  
Randomised Controlled

Abstract Background Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this. Methods/design The online ‘Complaint Directed Mini-Interventions’ (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline. Discussion This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care. Trial registration Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.

scholarly journals Protocol for a pragmatic randomised controlled trial of Body Brain Life—General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019329 ◽  
Author(s):  
Sarang Kim ◽  
Mitchell McMaster ◽  
Susan Torres ◽  
Kay L Cox ◽  
Nicola Lautenschlager ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Lifestyle Modification ◽  
Disease Risk ◽  
Short Form ◽  
Controlled Trial ◽  
Face To Face ◽  
Dementia Risk ◽  
Risk Reduction Intervention ◽  
Randomised Controlled

IntroductionIt has been estimated that a 10%–25% reduction in seven key risk factors could potentially prevent 1.1–3.0 million Alzheimer’s disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia.Methods and analysisA randomised controlled trial (RCT) is being conducted to evaluate three intervention programmes using a pragmatic approach suitable to the clinic: (1) a 12-week online and face-to-face dementia risk-reduction intervention (Body Brain Life—General Practice (BBL-GP)); (2) a 6-week face-to-face group lifestyle modification programme (LMP); and (3) a 12-week email-only programme providing general health information. We aim to recruit 240 participants, aged 18 and over, to undergo a comprehensive cognitive and physical assessment at baseline and follow-ups (postintervention, 18, 36 and 62 weeks). The primary outcome is dementia risk measured with the modified version of the Australian National University—Alzheimer’s Disease Risk Index Short Form. Secondary outcomes are cognitive function measured with Trails A and B, and the Digit Symbol Modalities Test; physical activity with moderate-vigorous physical activity and the International Physical Activity Questionnaire; depression with the Centre for Epidemiological Studies Depression; cost evaluation with the 12-item Short Form Health Survey, Framingham Coronary Heart Disease Risk Score and Australian Type 2 Diabetes Risk Assessment Tool; diet quality with the Australian Recommended Food Score; and sleep quality with the Pittsburgh Sleep Quality Index.Ethics and disseminationThis RCT is a novel pragmatic intervention applied in a primary care setting to reduce the dementia risk exposure in adults at high risk. If successful, BBL-GP and LMP will provide a versatile, evidence-based package that can be easily and quickly rolled out to other primary care settings and which can be scaled up at relatively low cost compared with other strategies involving intensive interventions.Trial registration numberACTRN12616000868482

scholarly journals Influence of overstated abstract conclusions on clinicians: a web-based randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018355 ◽  
Author(s):  
Kiyomi Shinohara ◽  
Takuya Aoki ◽  
Ryuhei So ◽  
Yasushi Tsujimoto ◽  
Aya M Suganuma ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Care Physicians ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Outcome Information ◽  
Significant Difference ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesTo investigate whether overstatements in abstract conclusions influence primary care physicians’ evaluations when they read reports of randomised controlled trials (RCTs)DesignRCT setting: This study was a parallel-group randomised controlled survey, conducted online while masking the study hypothesis.ParticipantsVolunteers were recruited from members of the Japan Primary Care Association in January 2017. We sent email invitations to 7040 primary care physicians. Among the 787 individuals who accessed the website, 622 were eligible and automatically randomised into ‘without overstatement’ (n=307) and ‘with overstatement’ (n=315) groups.InterventionsWe selected five abstracts from published RCTs with at least one non-significant primary outcome and overstatement in the abstract conclusion. To construct a version without overstatement, we rewrote the conclusion sections. The methods and results sections were standardised to provide the necessary information of primary outcome information when it was missing in the original abstract. Participants were randomly assigned to read an abstract either with or without overstatements and asked to evaluate the benefit of the intervention.Outcome measuresThe primary outcome was the participants’ evaluation of the benefit of the intervention discussed in the abstract, on a scale from 0 to 10. A secondary outcome was the validity of the conclusion.ResultsThere was no significant difference between the groups with respect to their evaluation of the benefit of the intervention (mean difference: 0.07, 95% CI −0.28 to 0.42, p=0.69). Participants in the ‘without’ group considered the study conclusion to be more valid than those in the ‘with’ group (mean difference: 0.97, 95% CI 0.59 to 1.36, P<0.001).ConclusionThe overstatements in abstract conclusions did not significantly influence the primary care physicians’ evaluations of the intervention effect when necessary information about the primary outcomes was distinctly reported.Trial registration numberUMIN000025317; Pre-results.

scholarly journals Exploratory randomised trial of face-to-face and mobile phone counselling against usual care for tobacco cessation in Indian primary care: a randomised controlled trial protocol for project CERTAIN

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e048628
Author(s):  
Rajmohan Panda ◽  
Rumana Omar ◽  
Rachael Hunter ◽  
Rajath R Prabhu ◽  
Arti Mishra ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Mobile Phone ◽  
Smokeless Tobacco ◽  
Tobacco Cessation ◽  
Controlled Trial ◽  
Routine Care ◽  
Ethics Committee ◽  
Face To Face ◽  
Randomised Controlled

IntroductionDespite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco. We hypothesise that mobile phone counselling will be feasible and effective for smokeless tobacco cessation intervention in India. This paper presents the protocol of the development and conduct of an exploratory trial before progression to a full randomised controlled trial.Methods and analysisAn exploratory randomised controlled trial will be conducted in urban primary health centres in the state of Odisha, India. A total of 250 smokeless tobacco users will be recruited to the study (125 in each arm). Participants in the intervention arm will receive routine care together with a face-to-face counselling intervention followed by advice and reminder mobile messages. The control arm will receive routine care, delivered by a primary care physician based on ‘Ask’ and ‘Advice’. All participants will be followed up for 3 months from the first counselling session. The primary outcome of this trial is to assess the feasibility to carry out a full randomised controlled trial.Ethics and disseminationEthical approvals were obtained from the Institutional Ethics Committee of Public Health Foundation of India, Health Ministry’s Screening Committee, Odisha State Ethics Board and also from University College London Research Ethics Committee, UK. The study findings will be published in a peer-reviewed scientific journal.Trial registration numberCTRI/2019/05/019484.

scholarly journals UTAH: Using Telemedicine to improve early medical Abortion at Home: a protocol for a randomised controlled trial comparing face-to-face with telephone consultations for women seeking early medical abortion

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046628
Author(s):  
John Joseph Reynolds-Wright ◽  
John Norrie ◽  
Sharon Tracey Cameron
Keyword(s):  
Controlled Trial ◽  
Medical Abortion ◽  
Is Success ◽  
Face To Face ◽  
Intention To Treat ◽  
Ethical Approval ◽  
Registration Number ◽  
Low Sensitivity ◽  
Randomised Controlled ◽  
The Uk

IntroductionEarly medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1–2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use of telemedicine for EMA. Our proposed research will determine if telephone consultations for EMA (the most common method of abortion in the UK) is non-inferior to standard face-to-face consultations with regard to the efficacy of EMA.Methods and analysisThis study will be conducted as an RCT. The recruitment target is 1222 participants.The primary outcome is success of EMA (complete abortion rate). This will be determined based on a negative low-sensitivity urine pregnancy test result (2 weeks after misoprostol use) and absence of surgical intervention or diagnosis of ongoing pregnancy (within 6 weeks of misoprostol).Secondary outcomes include total time spent at a clinic appointment to receive EMA, self-reported preparedness for EMA, level of satisfaction with consultation and effective contraception uptake compared with when women attend for a face-to-face consultation.The main analysis will be a modified intention-to-treat analysis. This will include all randomised women (with a viable pregnancy) using EMA and follow-up for the main outcome. The study initiated on 13 January 2020 and is anticipated to finish in late 2021.Ethics and disseminationEthical approval was given by the South East Scotland NHS Research Ethics Committee, reference: 19/SS/0111. Results will be published in peer-reviewed journals, presented at clinical and academic meetings, and shared with participants via the clinic website.Trial registration numberNCT04139382.

Acupuncture for Fibromyalgia in Primary Care: A Randomised Controlled Trial

2016 ◽  
Vol 34 (4) ◽  
pp. 257-266 ◽  
Author(s):  
Jorge Vas ◽  
Koldo Santos-Rey ◽  
Reyes Navarro-Pablo ◽  
Manuela Modesto ◽  
Inmaculada Aguilar ◽  
...  
Keyword(s):  
Primary Care ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Placebo Treatment ◽  
Sham Acupuncture ◽  
Intention To Treat ◽  
Sham Intervention ◽  
Registration Number ◽  
Randomised Controlled ◽  
Study Participants

Objectives To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia. Methods Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks. Results Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (−41.0%, 95% CI −47.2% to −34.8%) than in the SA group (−27.1%, 95% CI −33.2% to −20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: −19.9%, 95% CI −24.6% to −15.1%; vs SA: −6.2%, 95% CI −11.2% to −1.2%). Conclusions Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended. Trial Registration Number ISRCTN60217348.

Experiences in physical activity promotion in health care settings for primary prevention in the UK

2014 ◽  
Vol 62 (2) ◽  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Health Professionals ◽  
Controlled Trial ◽  
Full Range ◽  
Tertiary Care ◽  
Physical Activity Promotion ◽  
Community Based ◽  
Activity Promotion ◽  
Randomised Controlled

In addition to the delivery of primary care services, recent changes to the NHS in the United Kingdom have placed increasing responsibility on GPs for the commissioning of the full range of health services from prevention through to clinical interventions and rehabilitation. Whilst historically there has always been an expectation that primary care professionals were ideally placed to provide support for prevention as well as treatment, their active engagement in the promotion of physical activity has remained largely superficial. With notable exceptions where individuals have a personal interest or commitment, the majority of health professionals tend to limit themselves to peremptory non-specific advice at best, or frequently don’t broach the subject at all. There are a number of reasons for this including increasing time pressures, a general lack of knowledge, limited evidence and concerns about litigation in the event of an adverse exercise induced event. However in the 1990s there was a surge of interest in the emerging “Exercise on Prescription” model where patients could be referred to community based exercise instructors for a structured “prescription” of exercise in community leisure centres. Despite the continuing popularity of the model there remain problems particularly in getting the active support of health professionals who generally cite the same barriers as previously identified. In an attempt to overcome some of these problems Wales established a national exercise referral scheme with an associated randomised controlled trial. The scheme evaluated well and had subsequently evolved with new developments including integration with secondary and tertiary care pathways, accredited training for exercise instructors and exit routes into alternative community based exercise opportunities.

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