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GLA:D® Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study.

ABSTRACT: BACKGROUND:Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel. METHODS:The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8?weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. DISCUSSION:This implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

SUBMITTER: Kongsted A

PROVIDER: S-EPMC6380042 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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GLA:D<sup>®</sup> Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study.

Kongsted Alice A Ris Inge I Kjaer Per P Vach Werner W Morsø Lars L Hartvigsen Jan J

BMC musculoskeletal disorders 20190218 1

<h4>Background</h4>Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a ...[more]

PMID: 30777049

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Project description:BackgroundClinical guidelines recommend that people with back pain be given information and education about their back pain, advice to remain active and at work, and exercises to improve mobility and physical activity. Guidelines, however, rarely describe how this is best delivered. The aim of this paper is to present the development, theories, and underlying evidence for 'GLA:D Back' - a group education and exercise program that translates guideline recommendations into a clinician-delivered program for the promotion of self-management in people with persistent/recurrent back pain.MethodsGLA:D Back, which included a rationale and objectives for the program, theory and evidence for the interventions, and program materials, was developed using an iterative process. The content of patient education and exercise programs tested in randomised trials was extracted and a multidisciplinary team of expert researchers and clinicians prioritised common elements hypothesised to improve back pain beliefs and management skills. The program was tested on eight people with persistent back pain in a university clinic and 152 patients from nine primary care physiotherapy and chiropractic clinics. Following feedback from the clinicians and patients involved, the working version of the program was created.ResultsEducational components included pain mechanisms, pain modulation, active coping strategies, imaging, physical activity, and exercise that emphasised a balance between the sum of demands and the individual's capacity. These were operationalised in PowerPoint presentations with supporting text to aid clinicians in delivering two one-hour patient education lectures. The exercise program included 16 supervised one-hour sessions over 8 weeks, each comprising a warm-up section and eight types of exercises for general flexibility and strengthening of six different muscle groups at four levels of difficulty. The aims of the exercises were to improve overall back fitness and, at the same time, encourage patients to explore variations in movement by incorporating education content into the exercise sessions.ConclusionFrom current best evidence about prognostic factors in back pain and effective treatments for back pain, research and clinical experts developed a ready-to-use structured program - GLA:D® Back - to support self-management for people with persistent/recurrent back pain.

Project description:BackgroundClinical guidelines for management of low back pain (LBP) are not routinely implemented in practice, and guidelines rarely offer tools for implementation. Therefore, we developed GLA:D® Back, a standardised intervention of patient education and supervised exercises. This pilot study tested the feasibility of implementing GLA:D Back in clinical practice in Denmark by delivering a course for physiotherapists and chiropractors. It should further inform the planning of an implementation-effectiveness study using a pre-post group design alongside nation-wide implementation.MethodsThirty-one clinicians from nine clinics participated. Feasibility of implementation was evaluated in terms of adoption and through focus group interviews and a feedback meeting. Patient-level data, including pain, disability, and pain enablement, were collected from (1) LBP patients visiting the clinics during a pre-specified 2-week period 2 months prior to clinicians attending the GLA:D Back course (n = 84), (2) LBP patients consulting during a 2-week period 2 months after the course (n = 77), and (3) those enrolled in GLA:D Back during 4 months after implementation (n = 89). Patient data were collected at baseline and at 4 months.ResultsClinicians' evaluations of the course were positive and resulted in several modifications. The clinical intervention was adopted by all test sites. Most patient characteristics were similar across groups. Patients mainly had persistent LBP (73% > 3 months) and most had been treated for more than 4 weeks at inclusion. Patients in GLA:D Back were more often retired (30% vs. 16% before implementation) and at high risk of poor prognosis (25% vs. 13%). Procedures for data collection were feasible, and outcomes after implementation, especially with GLA:D Back, were as good as or better than before implementation. Recruiting patients and achieving comparable pre- and post-groups was difficult.ConclusionsImplementation of the GLA:D Back clinical intervention in Danish primary care physiotherapy and chiropractic clinics was feasible through a 2-day clinician course. Both clinicians and patients were satisfied with the programme, and patient-reported outcomes were slightly better than outcomes in patients registered before implementation. It was not deemed possible to conduct an implementation-effectiveness trial as part of a nation-wide implementation.

Project description:BackgroundPractice-based guidelines recommend patient education and exercise as first-line care for low back pain (LBP); however, these recommendations are not routinely delivered in practice. GLA:D® Back, developed in Denmark to assist clinicians to implement guideline recommendations, offers a structured education and supervised exercise program for people with LBP in addition to a clinical registry to evaluate patient outcomes. In this study we evaluated the feasibility of implementing the GLA:D® Back program in Australia. We considered clinician and patient recruitment and retention, program fidelity, exploring clinicians' and patients' experiences with the program, and participant outcome data collection.MethodsClinicians (chiropractors and physiotherapists) were recruited and participated in a 2-day GLA:D® Back training course. Patients were eligible to participate if they had persistent or recurrent LBP. Feasibility domains included the ability to: (1) recruit clinicians to undergo training; (2) recruit and retain patients in the program; (3) observe program fidelity; and (4) perceive barriers and facilitators for GLA:D® Back implementation. We also collected data related to: (5) clinician confidence, attitudes, and behaviour; and (6) patient self-reported outcomes related to pain, disability, and performance tests.ResultsTwenty clinicians (8 chiropractors, 12 physiotherapists) participated in the training, with 55% (11/20) offering GLA:D® Back to their patients. Fifty-seven patients were enrolled in the program, with 67% (38/57) attending the final follow-up assessment. Loss to follow up was mainly due to the effects of the COVID-19 pandemic. We observed program fidelity, with clinicians generally delivering the program as intended. Interviews revealed two clinician themes related to: (i) intervention acceptability; and (ii) barriers and facilitators to implementation. Patient interviews revealed themes related to: (i) intervention acceptability; and (ii) program efficacy. At 3 months follow-up, clinicians demonstrated high treatment confidence and biomedical orientation. Patient outcomes trended towards improvement.ConclusionGLA:D® Back implementation in Australia appears feasible based on clinician recruitment, program acceptability and potential benefits for patient outcomes from the small sample of participating clinicians and patients. However, COVID-19 impacted patient recruitment, retention, and data collection. To scale-up GLA:D® Back in private and public settings, further work is warranted to address associated barriers, and to leverage facilitators.

Project description:BackgroundLow back pain is often long-lasting, and implementation of low-cost interventions to improve care and minimise its burden is needed. GLA:D® Back is an evidence-based programme consisting of patient education and supervised exercises for people with low back pain, which was implemented nationwide in primary care clinics in Denmark. To assess how the intervention was received and factors influencing adherence to the program, we aimed to evaluate participants' adherence to the intervention and identified characteristics related to the completion of GLA:D® Back. Specifically, we investigated: 1) level of attendance of participants enrolled in the programme, and 2) participant-related factors associated with low attendance.MethodsPrimary care clinicians delivered GLA:D® Back, a standardised 10-week programme of 2 educational and 16 supervised exercise sessions, to patients with low back pain. Attendance was defined as low, medium or high based on self-reported number of attended sessions. Additional participant-reported data included demographic characteristics, pain, prognostic risk profiles, self-efficacy, illness-beliefs, function and clinician-reported physical performance tests. Results for high, medium, low, and unknown attendance were reported descriptively. Odds ratios for low attendance compared to medium/high attendance were calculated by including all baseline factors in a mixed-model logistic regression model.ResultsOf 1730 participants, 52% had high, 23% medium, and 25% low levels of attendance. Level of attendance was not strongly associated with participants' individual factors, but in combination, prediction of low attendance was fair (AUC 0.77; 95% CI 0.74-0.79). The strongest indicator of low attendance was not completing the baseline questionnaire.ConclusionsMost participants of a 10-week low back pain programme attended almost all session. Non-response to the baseline questionnaire was strongly associated with low attendance, whereas individual patient characteristics were weakly related to attendance. Not completing baseline questionnaires might be an early indicator of poor adherence in programs for people with persistent low back pain.Trial registrationThe Health Research Ethics for Southern Denmark decided there was no need for ethical approval (S-20172000-93). The Danish data collection has obtained authorisation from the Danish Data Protection Agency as part of the University of Southern Denmark's institutional authorisation (DPA no. 2015-57-0008 SDU no. 17/30591). The trial was registred at ClinicalTrials.gov NCT03570463 .

Project description:BackgroundPediatric pain is a complex health challenge requiring a multi-modal management approach. It is critical that healthcare providers (HCPs) have access to ongoing, flexible education and mentorship specific to pediatric pain. However, there are significant gaps in available pain education and a need for more opportunities to support interprofessional training. Project Extension for Community Healthcare Outcomes (Project ECHO®) is a model for delivering online HCP education and cultivating a virtual community of practice. Within the pediatric pain setting, ECHO® has potential to improve local access to specialized pain knowledge, particularly among the physicians, nurses, and allied health providers who primarily manage these cases in community and hospital settings across rural and urban environments. The purpose of this study was three-fold. First, to evaluate the feasibility (participation levels, acceptability) of implementing Project ECHO® in the context of pediatric pain. Second, to measure preliminary program impacts on HCP knowledge, self-efficacy, and clinical practice. Third, to characterize HCP program engagement levels before and after onset of the COVID-19 pandemic.MethodsA needs assessment was conducted to identify interprofessional education gaps and inform the program curriculum. The no-cost Pediatric ECHO® for Pain program offered TeleECHO sessions (didactic and case-based learning) as well as foundational education. Surveys were distributed at baseline and 6 months to assess outcomes using 7-point Likert scales. Participant engagement was assessed for periods prior to and during the COVID-19 pandemic. Descriptive and inferential statistical analyses were conducted.ResultsEighty-five TeleECHO sessions were hosted, with a mean attendance of 34.1 ± 23.4 HCPs. Acceptability scores at 6 months (n = 33) ranged from 5.0 ± 1.4 to 6.5 ± 0.5. Participants reported statistically significant (p < 0.05) improvements in knowledge (7 out of 7 topics) and self-efficacy (8 out of 9 skills). Most participants reported positive practice impacts, including improved satisfaction with managing children with pain. Exploratory analyses showed a trend of greater engagement from ECHO® learners after onset of the COVID-19 pandemic.ConclusionsProject ECHO® is a feasible and impactful model for virtual education of interprofessional HCPs in managing pediatric pain.

Project description:BackgroundThe aim of this study was to compare a commercial dosimetry workstation (PLANET® Dose) and the dosimetry approach (GE Dosimetry Toolkit® and OLINDA/EXM® V1.0) currently used in our department for quantification of the absorbed dose (AD) to organs at risk after peptide receptor radionuclide therapy with [177Lu]Lu-DOTA-TATE.MethodsAn evaluation on phantom was performed to determine the SPECT calibration factor variations over time and to compare the Time Integrated Activity Coefficients (TIACs) obtained with the two approaches. Then, dosimetry was carried out with the two tools in 21 patients with neuroendocrine tumours after the first and second injection of 7.2 ± 0.2 GBq of [177Lu]Lu-DOTA-TATE (40 dosimetry analyses with each software). SPECT/CT images were acquired at 4 h, 24 h, 72 h and 192 h post-injection and were reconstructed using the Xeleris software (General Electric). The liver, spleen and kidneys masses and TIACs were determined using Dosimetry Toolkit® (DTK) and PLANET® Dose. The ADs were calculated using OLINDA/EXM® V1.0 and the Local Deposition Method (LDM) or Dose voxel-Kernel convolution (DK) on PLANET® Dose.ResultsWith the phantom, the 3D calibration factors showed a slight variation (0.8% and 3.3%) over time, and TIACs of 225.19 h and 217.52 h were obtained with DTK and PLANET® Dose, respectively. In patients, the root mean square deviation value was 8.9% for the organ masses, 8.1% for the TIACs, and 9.1% and 7.8% for the ADs calculated with LDM and DK, respectively. The Lin's concordance correlation coefficient was 0.99 and the Bland-Altman plot analysis estimated that the AD value difference between methods ranged from - 0.75 to 0.49 Gy, from - 0.20 to 0.64 Gy, and from - 0.43 to 1.03 Gy for 95% of the 40 liver, kidneys and spleen dosimetry analyses. The dosimetry method had a minor influence on AD differences compared with the image registration and organ segmentation steps.ConclusionsThe ADs to organs at risk obtained with the new workstation PLANET® Dose are concordant with those calculated with the currently used software and in agreement with the literature. These results validate the use of PLANET® Dose in clinical routine for patient dosimetry after targeted radiotherapy with [177Lu]Lu-DOTA-TATE.

Project description:ObjectiveTo determine the efficacy, safety, and durability of the use of AHCC supplementation for 6 months to support the host immune system to clear high-risk human papillomavirus (HPV) infections. The AHCC supplement is a proprietary, standardized extract of cultured lentinula edodes mycelia (AHCC®, Amino Up, Ltd., Sapporo, Japan) that has been shown to have unique immune modulatory benefits.Study designThis was a randomized, double-blind, placebo-controlled study (CTN: NCT02405533) in 50 women over 30 years of age with confirmed persistent high-risk HPV infections for greater than 2 years. Patients were randomized to placebo once daily for 12 months (N = 25) or AHCC 3-g supplementation by mouth once daily on empty stomach for 6 months followed by 6 months of placebo (N = 25). Every 3 months, patients were evaluated with HPV DNA and HPV RNA testing as well as a blood sample collected to evaluate a panel of immune markers including interferon-alpha, interferon-beta (IFN-β), interferon-gamma (IFN-γ), IgG1, T lymphocytes, and natural killer (NK) cell levels. At the completion of the 12-month study period, patients on the placebo arm were given the option to continue on the study to receive AHCC supplementation unblinded for 6 months with the same follow-up appointments and testing as the intervention arm.ResultsFifty women with high-risk HPV were enrolled, and 41 completed the study. Fourteen (63.6%) of the 22 patients in the AHCC supplementation arm were HPV RNA/HPV DNA negative after 6 months, with 64.3% (9/14) achieving a durable response defined as being HPV RNA/HPV DNA negative 6 months off supplementation. On the placebo arm, two (10.5%) of 19 patients were HPV negative at 12 months. In the twelve placebo arm patients who elected to continue on the unblinded study, 50% (n = 6) were HPV RNA/HPV DNA negative after 6 months of AHCC supplementation. At the time of completion of the study, there were a total of 34 patients (22 blinded and 12 unblinded) who had received AHCC supplementation with an overall response rate of 58.8% that cleared HPV persistent infections. At the time of enrollment, the mean IFN-β level was 60.5 ± 37.6 pg/ml in women with confirmed persistent HPV infections. Suppression of IFN-β to less than 20 pg/ml correlated with an increase in T lymphocytes and IFN-γ and durable clearance of HPV infections in women who received AHCC supplementation.ConclusionResults from this phase II study demonstrated that AHCC 3 g once daily was effective to support the host immune system to eliminate persistent HPV infections and was well tolerated with no significant adverse side effects reported. The duration of AHCC supplementation required beyond the first negative result needs more evaluation to optimize success for durable outcomes. The suppression of the IFN-β level to less than 20 pg/ml correlated with clearance of HPV infections and merits further evaluation as a clinical tool for monitoring patients with HPV infections.Clinical trial registrationclinicaltrials.gov/ct2/, identifier NCT02405533.

Project description:IMPORTANCE:Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy's feasibility and efficacy in primary care settings. OBJECTIVE:To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign® (LR)-occupational therapy (LR-OT) diabetes management intervention in a primary care clinic. DESIGN:Patients were randomized to be offered LR-OT or to a no-contact comparison group (data not reported). We assessed implementation outcomes using mixed methods. SETTING:Safety-net primary care clinic. PARTICIPANTS:Clinic providers and staff; English- or Spanish-speaking clinic patients ages 18-75 yr with diabetes and a current hemoglobin A1c (HbA1c) ? 9.0%. INTERVENTION:Eight 1-hr individual sessions of LR-OT focused on diabetes management. OUTCOMES AND MEASURES:Clinical and health behavior outcomes were assessed via electronic medical record (EMR) review and self-report surveys of patients receiving LR-OT at initial evaluation and discharge. We assessed implementation outcomes (acceptability, appropriateness, feasibility, fidelity, efficiency, and timeliness) using patient and staff surveys, interviews, focus groups, and observations. RESULTS:Seventy-three patients were offered LR-OT: 51 completed one or more sessions, and 38 completed the program. Clinical outcomes among program completers indicate beneficial changes in HbA1c, diabetes self-care, and health status. Implementation challenges included a need for patient and staff education, securing adequate workspace, and establishing a referral process. Factors contributing to implementation success included strong buy-in from clinic leadership, colocation, and shared EMR documentation. CONCLUSIONS AND RELEVANCE:LR-OT is a feasible approach to enhancing service delivery and clinical outcomes in primary care. WHAT THIS ARTICLE ADDS:This study provides insight into factors that may create challenges or contribute to the success of implementing occupational therapy services within primary health care settings. In addition, this study provides preliminary evidence of occupational therapy's effectiveness in improving clinical outcomes among ethnically diverse, low-income patients with diabetes in a safety-net primary care setting.

Dataset Information

GLA:D® Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study.

Publications

GLA:D<sup>®</sup> Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study.

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