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Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial).

ABSTRACT: OBJECTIVE:In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. RESULTS:We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.

SUBMITTER: Riis A

PROVIDER: S-EPMC6954533 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial).

Riis Allan A Rathleff Michael Skovdal MS Hartvigsen Jan J Thomsen Janus Laust JL Afzali Tamana T Jensen Martin Bach MB

BMC research notes 20200110 1

<h4>Objective</h4>In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is ...[more]

PMID: 31924258

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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:BackgroundLow back pain (LBP) is a long-term health condition with an unpredictable pattern of symptomatic episodes, remission, and recurrence. Recently published systematic reviews suggest that exercise is the most effective intervention for preventing recurrences of LBP in persons that have recovered. Similar programs may also be effective in preventing flare-ups in persistent LBP. The aim of this study was to test the feasibility of the Back to Living Well program (Physical activity + Education + Self-management) developed to prevent recurrence or flare-ups of LBP. The study evaluated feasibility in terms of recruitment rate, adherence, satisfaction with the exercise and education sessions, and the data collection procedures. We also aimed to evaluate barriers and facilitators to the engagement in the program.MethodsSeventeen participants with non-specific LBP recently discharged from care from physiotherapy, chiropractors or physician care (< 3 months) were referred to the study by health care providers or community advertisements between December 2018 and February 2019. Participants underwent a 12-week (1 session/week) individualized, group-based exercise in the community and 4 sessions (30 min each) of education. All participants completed an action plan weekly for 12 weeks and wore an activity monitor for 6 months. All participants responded to weekly pain measures and completed study questionnaires at baseline, 3- and 6-months. Feasibility outcomes included recruitment, attrition rates and satisfaction. At the end of the intervention, participants completed an end-of-program survey.ResultsTwenty-nine participants were screened for eligibility; 20 were deemed eligible, while 17 were included over a 2-month period meeting our feasibility targets. In total, 16 completed follow-up study questionnaires at 3 months, and 15 completed the 6-month follow-up. Fourteen participants responded to weekly messages, while 3 participants reported not having a mobile device or Internet access. In total, 15 participants responded to our end-of-program survey. Average age was 54.9 (11.7); 9 were female (53%), and the mean duration of LBP was 62.9 (69.7) months. All satisfaction responses in relation to the exercise program, education program and data collection procedures reached our threshold of 70% out of 100%. Reported barriers to engagement in the program included fear of injury, lack of motivation and travel. Facilitators included proximity to home, low cost, flexible schedule and friendly location.ConclusionThe results show the program is feasible in terms of recruitment, low attrition, and patient satisfaction. Participants highlighted the excellent, relevant education program and the positive, personalized exercise. Future studies should evaluate the effectiveness of this intervention within a fully powered randomized controlled trial.Trial registrationNCT03328689.

Project description:BACKGROUND:Information on self-management, including addressing people's fears and concerns, are core aspects of managing patients with low back pain (LBP). Web apps with patient information may be used to extend patient-physician consultations and encourage self-management outside of the consultation room. It is, however, important to identify the end users' needs and preferences in order to maximize acceptance. OBJECTIVE:The aim of this study was to identify preferences for the content, design, and functionality of a Web app with evidence-based information and advice for people with LBP in Denmark. METHODS:This is a phenomenological qualitative study. Adults who had consulted their general practitioner because of LBP within the past 14 days were included. Each participated in a semistructured interview, which was audiotaped and transcribed for text condensation. Interviews were conducted at the participant's home by 2 interviewers. Participants also completed a questionnaire that requested information on age, gender, internet usage, interest in searching new knowledge, LBP-related function, and pain. RESULTS:Fifteen 45-min interviews were conducted. Participants had a median age of 40 years (range 22-68 years) and reported a median disability of 7 points (range 0-18) using the 23-item Roland Morris Disability Questionnaire. Participants reported that Web-based information should be easy to find and read, easily overviewed, and not be overloaded with information. Subjects found existing Web-based information confusing, often difficult to comprehend, and not relevant for them, and they questioned the motives driving most hosting companies or organizations. The Patient Handbook, a Danish government-funded website that provides information to Danes about health, was mentioned as a trustworthy and preferred site when searching for information and advice regarding LBP. CONCLUSIONS:This study identified important issues to consider when developing and supplementing existing general practice treatment with Web-based information and advice for patients with LBP. Development of a Web app should consider patient input, and developers should carefully address the following domains: readability, customization, design, credibility, and usability.

Project description:BACKGROUND:Low back pain (LBP) is a common cause of contact with the primary healthcare sector. In some patients, symptoms quickly resolve, but others develop long-lasting pain and disability. To improve the care pathway for patients with LBP, the STarT Back Tool (STarT) questionnaire has been developed. It helps initial decision-making by subgrouping patients on the basis of their prognosis and helps to target treatment according to prognosis. An assumption behind the use of STarT is the ability to predict functional improvement. This assumption has never been tested in a population that consists exclusively of patients enrolled when consulting a Danish general practitioner for LBP. The aim of this study was to investigate STarT's ability to predict a 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score. METHODS:This was an ancillary analysis using data from a Danish guideline implementation study (registered at ClinicalTrials.gov NCT01699256). An inclusion criterion was age 18 to 65 years of age. Exclusion criteria were pregnancy, fractures, and signs of underlying pathology. Patient-reported STarT score and the Roland Morris Disability Questionnaire were administered at baseline and again after 4, 8, and 52 weeks. RESULTS:Between January 2013 and July 2014, 475 patients from the original trial participated with questionnaires. From this subpopulation, 441 (92.8%) patients provided information regarding STarT. Baseline and eight-week RMDQ data were available for 304 (64.0%) patients. After 8 weeks, 61 (65.6%) in the low-risk group, 67 (54.9%) in the medium-risk group, and 33 (37.1%) in the high-risk group had achieved a 30% improvement in the RMDQ score. After 8 weeks, high-risk patients were at 61% (95% CI: 20-125%, P < 0.001) higher risk of not achieving a 30% improvement in the RMDQ score compared with patients in either the low-risk group or the medium-risk group. CONCLUSION:STarT was predictive for functional improvement in patients from general practice with LBP. TRIAL REGISTRATION:ClinicalTrials.gov NCT01699256 , Nov 29, 2016 (registered retrospectively).

Dataset Information

Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial).

Publications

Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial).

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