Dataset Information

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).

ABSTRACT: BACKGROUND:The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. METHODS:This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6?weeks (behaviour change only), 2?months and 6?months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants' cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. RESULTS:Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD)?=?4.92 (1.31), range 2-7; UP: mean (SD)?=?5.08 (2.43), range 1-9). One hundred twenty participants (83.3% of n?=?144 expected) were recruited (intervention n?=?59; UP n?=?61), with follow-up data obtained from 80.8% (n?=?97) at 6?weeks, 84.2% (n?=?101) at 2?months and 71.7% (n?=?86) at 6?months. Most participants received treatment as allocated (intervention n?=?49; UP n?=?54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6?months with small between-group effects. CONCLUSIONS:While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. TRIAL REGISTRATION:ISRCTN ISRCTN49875385 . Registered on 26 March 2014.

SUBMITTER: Hurley DA

PROVIDER: S-EPMC7510107 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).

Hurley Deirdre A DA Jeffares Isabelle I Hall Amanda M AM Keogh Alison A Toomey Elaine E McArdle Danielle D McDonough Suzanne M SM Guerin Suzanne S Segurado Ricardo R Matthews James J

Trials 20200923 1

<h4>Background</h4>The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial.<h4>Methods</h4>This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention ...[more]

PMID: 32967713

Similar Datasets

Project description:BackgroundBlended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective.MethodsThis economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty.ResultsIntervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (<?0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective.ConclusionsE-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist.Trial registrationNTR4224 (25 October 2013).

Project description:BackgroundThe Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system.MethodsThe six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory.ResultsThe SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback.ConclusionsThe SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

Project description:BACKGROUND:By adaptation of the face-to-face physiotherapist-training program previously used in the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) feasibility trial, an asynchronous, interactive, Web-based, e-learning training program (E-SOLAS) underpinned by behavior and learning theories was developed. OBJECTIVE:This study investigated the effect of the E-SOLAS training program on relevant outcomes of effective training and implementation. METHODS:Thirteen physiotherapists from across Ireland were trained via E-SOLAS by using mixed methods, and seven physiotherapists progressed to implementation of the 6-week group-based SOLAS intervention. The effectiveness of E-SOLAS was evaluated using the Kirkpatrick model at the levels of reaction (physiotherapist engagement and satisfaction with E-SOLAS training methods and content), learning (pre- to posttraining changes in physiotherapists' confidence and knowledge in delivering SOLAS content and self-determination theory-based communication strategies, administered via a SurveyMonkey questionnaire), and behavior (fidelity to delivery of SOLAS content using physiotherapist-completed weekly checklists). During implementation, five physiotherapists audio recorded delivery of one class, and the communication between physiotherapists and clients was assessed using the Health Care Climate Questionnaire (HCCQ), the Controlling Coach Behaviour Scale (CCBS), and an intervention-specific measure (ISM; 7-point Likert scale). A range of implementation outcomes were evaluated during training and delivery (ie, acceptability, appropriateness, feasibility, fidelity, and sustainability of E-SOLAS) using a posttraining feedback questionnaire and individual semistructured telephone interviews. RESULTS:With regard to their reaction, physiotherapists (n=13) were very satisfied with E-SOLAS posttraining (median 5.0; interquartile range 1.0; min-max 4.0-5.0) and completed training within 3-4 weeks. With regard to learning, there were significant increases in physiotherapists' confidence and knowledge in delivery of all SOLAS intervention components (P<.05). Physiotherapists' confidence in 7 of 10 self-determination theory-based communication strategies increased (P<.05), whereas physiotherapists' knowledge of self-determination theory-based strategies remained high posttraining (P>.05). In terms of behavior, physiotherapists delivered SOLAS in a needs supportive manner (HCCQ: median 5.2, interquartile range 1.3, min-max 3.7-5.8; CCBS: median 6.6, interquartile range 1.0, min-max 5.6-7.0; ISM: median 4.5, interquartile range 1.2, min-max 2.8-4.8). Fidelity scores were high for SOLAS content delivery (total %mean fidelity score 93.5%; SD 4.9%). The posttraining questionnaire and postdelivery qualitative interviews showed that physiotherapists found E-SOLAS acceptable, appropriate, feasible, and sustainable within primary care services to support the implementation of the SOLAS intervention. CONCLUSIONS:This study provides preliminary evidence of the effectiveness, acceptability, and feasibility of an e-learning program to train physiotherapists to deliver a group-based self-management complex intervention in primary care settings, which is equivalent to face-to-face training outcomes and would support inclusion of physiotherapists in a definitive trial of SOLAS.

Project description:OBJECTIVES: Firstly, to compare the effectiveness of a brief physiotherapy intervention with "usual" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome. DESIGN: Non-inferiority randomised controlled trial eliciting preferences independently of randomisation. SETTING: Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire. PARTICIPANTS: 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned. MAIN OUTCOME MEASURES: The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement. RESULTS: At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy. CONCLUSIONS: Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.

Project description:IntroductionThis study examines the uptake of a clinician-focused teachable moment communication process (TMCP) and its impact on patient receipt of tobacco cessation support. The TMCP is a counseling method that uses patient concerns to help clinicians guide behavior change discussions about tobacco. We evaluate the added value of the TMCP training in a health system that implemented an Ask-Advise-Connect (AAC) systems-based approach.MethodsA stepped wedge cluster randomized trial included eight community health centers. Training involved a web module and onsite skill development with standardized patients and coaching. Main outcome measures included contact and enrollment in cessation services among patients referred for counseling, prescription of cessation medications and quit attempts.ResultsForty-four of 60 eligible clinicians received the TMCP training. Among TMCP-trained clinicians 68% used a TMCP approach (documented by flowsheet use) one or more times, with the median number of uses being 15 (IQR 2-33). Overall, the TMCP was used in 661 out of 8198 visits by smokers (8%). There was no improvement in any of the tobacco cessation assistance outcomes for the AAC + TMCP vs. the AAC only period. Visits where clinicians used the TMCP approach were associated with increased ordering of tobacco cessation medications, (OR = 2.6; 95% CI = 1.9, 3.5) and providing advice to quit OR 3.2 (95% CI 2.2, 4.7).ConclusionsDespite high fidelity to the training, uptake of the TMCP approach in routine practice was poor, making it difficult to evaluate the impact on patient outcomes. When the TMCP approach was used, ordering tobacco cessation medications increased.ImplicationsTobacco cessation strategies in primary care have the potential to reach a large portion of the population and deliver advice tailored to the patient. The poor uptake of the approach despite high training fidelity suggests that additional implementation support strategies, are needed to increase sustainable adoption of the TMCP approach.Trial registrationclinicaltrials.gov #NCT02764385 , registration date 06/05/2016.

Project description:BackgroundPrimary care access can be challenging for older, rural, socio-economically disadvantaged populations. Here we report the I-ACT cluster feasibility trial which aims to assess the feasibility of trial design and context-sensitive intervention to improve primary care access for this group and so expand existing theory.MethodsFour general practices were recruited; three randomised to intervention and one to usual care. Intervention practices received £1500, a support manual and four meetings to develop local, innovative solutions to improve the booking system and transport. Patients aged over 64 years old and without household car access were recruited to complete questionnaires when booking an appointment or attending the surgery. Outcome measures at 6 months included: self-reported ease of booking an appointment and transport; health care use; patient activation; capability; and quality of life. A process evaluation involved observations and interviews with staff and participants.ResultsThirty-four patients were recruited (26 female, eight male, mean age 81.6 years for the intervention group and 79.4 for usual care) of 1143 invited (3% response rate). Most were ineligible because of car access. Twenty-nine participants belonged to intervention practices and five to usual care. Practice-level data was available for all participants, but participant self-reported data was unavailable for three. Fifty-six appointment questionnaires were received based on 150 appointments (37.3%). Practices successfully designed and implemented the following context-sensitive interventions: Practice A: a stacked telephone system and promoting community transport; Practice B: signposting to community transport, appointment flexibility, mobility scooter charging point and promoting the role of receptionists; and Practice C: local taxi firm partnership and training receptionists. Practices found the process acceptable because it gave freedom, time and resource to be innovative or provided an opportunity to implement existing ideas. Data collection methods were acceptable to participants, but some found it difficult remembering to complete booking and appointment questionnaires. Expanded theory highlighted important mechanisms, such as reassurance, confidence, trust and flexibility.ConclusionsRecruiting older participants without access to a car proved challenging. Retention of participants and practices was good but only about a third of appointment questionnaires were returned. This study design may facilitate a shift from one-size-fits-all interventions to more context-sensitive interventions.Trial registrationISRCTN18321951 , Registered on 6 March 2017.

Dataset Information

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).

Publications

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets