Dataset Information

Developing the Network Pain Rehabilitation Limburg: a feasibility study protocol.

ABSTRACT: INTRODUCTION:Patients having chronic musculoskeletal pain (CMP) face challenges as mismatches often exist between the complexity of patient's pain problem and the rehabilitation treatment offered. This can result in less efficient care for the patient and increased medical shopping. The Network Pain Rehabilitation Limburg (NPRL), a transmural integrated healthcare network, will be designed to improve daily care for patients with CMP. NPRL focusses on improving patient's level of functioning despite pain by stimulating a biopsychosocial approach given by all involved healthcare professionals. A feasibility study will be performed which will give insight into the barriers and facilitators, perceived value, acceptability and implementation strategies for NPRL. METHODS AND ANALYSIS:This study has a three-phase iterative and incremental design, based on key principles of a user-centred design. Mixed methods will be used in which healthcare professionals and patients involved in NPRL will participate. In phase 1, NPRL will be developed and healthcare professionals educated. Phase 2 focusses on the implementation and phase 3 on the transferability of NPRL. In addition, preliminary data on patient's work status, general health and participation level will be collected. The qualitative results of each phase will be analysed following the Consolidated Framework for Implementation Research (CFIR) and will be used to refine NPRL in daily practise. ETHICS AND DISSEMINATION:Informed consent will be obtained from all participants. The results of this feasibility study will form the basis for refinement of NPRL and planning of a large-scale process and effect evaluation of the Quadruple Aim outcomes. Dissemination will include publications and presentations at national and international conferences. Ethical approval for this study was granted by the Medical Ethics Committee Z, the Netherlands, METC 17?N-133.

SUBMITTER: Lamper C

PROVIDER: S-EPMC6597742 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Developing the Network Pain Rehabilitation Limburg: a feasibility study protocol.

Lamper Cynthia C Kroese Mariëlle M Köke Albère A Ruwaard Dirk D Verbunt Jeanine J Huijnen Ivan I

BMJ open 20190627 6

<h4>Introduction</h4>Patients having chronic musculoskeletal pain (CMP) face challenges as mismatches often exist between the complexity of patient's pain problem and the rehabilitation treatment offered. This can result in less efficient care for the patient and increased medical shopping. The Network Pain Rehabilitation Limburg (NPRL), a transmural integrated healthcare network, will be designed to improve daily care for patients with CMP. NPRL focusses on improving patient's level of function ...[more]

PMID: 31248917

Similar Datasets

Project description:BACKGROUND:While cardiac rehabilitation has been shown to be effective at improving coronary heart disease (CHD), participation is generally poor. Attempts to increase uptake and adherence often fail. Use of a Facebook intervention for this population may be a unique opportunity to support self-determined motivation and affect adherence. OBJECTIVE:To evaluate the impact of a Facebook intervention on motivation for exercise and adherence to cardiac rehabilitation in patients with CHD during a 12-week, Phase II cardiac rehabilitation program. METHODS:A prospective, randomized controlled pilot study, grounded in Self-Determination Theory, will be conducted. Participants will be recruited from inpatient, or the intake visit to outpatient, cardiac rehabilitation, and then randomly assigned to the intervention or comparison group. Participants in the intervention group will take part in a private Facebook group. Weekly posts will be designed to support self-determined motivation, measured at baseline and postcardiac rehabilitation by the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The Psychological Need Satisfaction for Exercise (PNSE) scale will measure fulfillment of needs that affect motivation. Participants in the comparison group will be given the same materials, but these will be supplied via handouts and email. The number of sessions attended will be tallied and analyzed using t tests. Overall motivation will be evaluated using analysis of covariance (ANCOVA) models. Multivariate analysis of variance models will be used to evaluate differences in the change across motivation subtypes. If significant, ANCOVA models for each subtype will be fit. ANCOVA models will be used to compare changes in needs satisfaction, overall and separately among the three subscales, between groups. Engagement in the Facebook group will be measured by number of "likes" and self-report of weekly visits to the group. RESULTS:This project was funded in July 2017 and recruitment is currently underway. The recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. CONCLUSIONS:This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa).

Project description:IntroductionArm weakness is a common problem after stroke (affecting 450 000 people in the UK) leading to loss of independence. Repetitive activity is critical for recovery but research shows people struggle with knowing what or how much to do, and keeping track of progress. Working with more than 100 therapists (occupational therapists and physiotherapists) and patients with stroke, we codeveloped the OnTrack intervention-consisting of software for smart devices and coaching support-that has the potential to address this problem. This is a protocol to assess the feasibility of OnTrack for evaluation in a randomised control trial.Methods and analysisA mixed-method, single-arm study design will be used to evaluate the feasibility of OnTrack for hospital and community use. A minimum sample of 12 participants from a stroke unit will be involved in the study for 14 weeks. During week 1, 8 and 14 participants will complete assessments relating to their arm function, arm impairment and activation. During weeks 2-13, participants will use OnTrack to track their arm movement in real time, receive motivational messages and face-to-face sessions to address problems, gain feedback on activity and receive self-management skills coaching. All equipment will be loaned to study participants. A parallel process evaluation will be conducted to assess the intervention's fidelity, dose and reach, using a mixed-method approach. A public and patient involvement group will oversee the study and help with interpretation and dissemination of qualitative and quantitative data findings.Ethics and disseminationEthical approval granted by the National Health Service Health Research Authority, Health and Care Research Wales, and the London-Surrey Research Ethics Committee (ref. 19/LO/0881). Trial results will be submitted for publication in peer review journals, presented at international conferences and disseminated among stroke communities. The results of this trial will inform development of a definitive trial.Trial registration numberNCT03944486.

Project description:BackgroundMillions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.MethodsThe aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).DiscussionAn improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.Trial registrationDRKS, DRKS00020373 . Registered on 15 April 2020.

Project description:IntroductionKnee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.Methods and analysisIn phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.Ethics and disseminationThis protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.Trial registration numberNCT03670706.

Project description:INTRODUCTION:Following cardiac surgery, patients currently attend an outpatient review 6?weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8?weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES:This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION:Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER:ISRCTN80441309.

Project description:BackgroundDespite the variety of pulmonary rehabilitation programmes for patients living with COPD, uptake remains low. To improve this, it is recommended that health professionals engage patients in informed decisions about pulmonary rehabilitation. Shared decision-making (SDM) facilitates informed and value-based decision-making between patients and health professionals. This protocol describes the development and evaluation of a complex SDM intervention for patients living with COPD, who are referred for pulmonary rehabilitation, and their pulmonary rehabilitation health professional.Methods and analysisWe are developing a complex SDM intervention involving a patient decision aid (PtDA) and a decision coaching workshop. Prior to patient recruitment, pulmonary rehabilitation health professionals will attend the workshop. Upon referral to pulmonary rehabilitation, patients will receive the PtDA to support their decision-making prior to and during their pulmonary rehabilitation assessment with a health professional. The intervention will be evaluated in a one-arm exploratory study to investigate its feasibility and acceptability for patients and health professionals, with an integrated fidelity assessment. The primary outcome is recruitment feasibility, data collection feasibility and intervention fidelity. Secondary outcomes include routine pulmonary rehabilitation data, decisional conflict, patient activation, intervention attendance/attrition and patient and pulmonary rehabilitation health professional experience of the intervention. Quantitative outcomes will be evaluated using the most appropriate statistical test, dependent on the sample distribution. Qualitative outcomes will be evaluated using reflexive thematic analysis. Fidelity will be assessed using the Observer OPTION 5 scale.ConclusionThis intervention will provide structure for an informed and values-based decision-making consultation between a patient with COPD and a pulmonary rehabilitation health professional with the potential for optimising pulmonary rehabilitation decision-making.

Project description:BackgroundDizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness.MethodsForty adult patients will be recruited from a tertiary vestibular clinic with persistent movement-triggered dizziness for 3 months or longer who have moderate-high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement.DiscussionIf a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention.Trial registrationClinicalTrials.gov, ISRCTN 10420559.

Dataset Information

Developing the Network Pain Rehabilitation Limburg: a feasibility study protocol.

Publications

Developing the Network Pain Rehabilitation Limburg: a feasibility study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure