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Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial.

ABSTRACT: BACKGROUND:Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management. METHODS/DESIGN:The EFFADOL study is a stepped-wedge randomised controlled trial. A total of 260 cancer patients with unbalanced background pain will be randomised over the institutional level, i.e. stepped-wedge cluster design. Six clusters will be formed, one at the regional level of "Basse-Normandie" for patients receiving the educational approach by health providers already trained to TPE. Then, five additional centers will be gradually included at the national level, making it possible to compare the "conventional" management of pain (before medical staff training to TPE) with the educational approach (after being trained). The main study parameter is pain interference on daily life assessed with the self-administrated and validated Brief Pain Inventory questionnaire. Secondary objectives comprised the evaluation of patients' adherence to pain education program, the description of pain intensity, pain relief, analgesic adherence and pain emotional impact. Educational dimension of the program will be evaluated through the patients' acquisition of knowledge and skills about their pain and treatment as well as their self-efficacy to participate actively in pain management. The patient's feeling of pain changes will be measured. Finally, the satisfaction of participants and educators will be reported. We hypothetise active involvement of patients in TPE will lead to an improved pain management compared to standard care. DISCUSSION:Analyzing the impact of a TPE program in cancer pain patients will improve their pain management and quality of life. We expect that the dissemination of our project educational approach through the French territory will be accompanied by long term change in clinical practices with mutual benefit to patients and caregiver-educators. TRIAL REGISTRATION:NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.

SUBMITTER: Prevost V

PROVIDER: S-EPMC6615097 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial.

Prevost Virginie V Heutte Natacha N Leconte Alexandra A Licaj Idlir I Delorme Claire C Clarisse Bénédicte B

BMC cancer 20190708 1

<h4>Background</h4>Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management.<h4>Methods/design</h4>The EFFADOL study is a stepped-wedge randomised controlled ...[more]

PMID: 31286871

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Project description:ObjectiveThis study aimed to investigate the effectiveness of workplace active rest programme (WARP) on chronic low back pain (LBP) among office workers.DesignA closed cohort, stepped-wedge cluster randomised trial was conducted. The total duration of the study was 16 weeks (4 weeks for each step). Sequence allocation was randomised, but no one was blinded.SettingThis study was conducted in three offices in a Japanese electronics company. One office was for the administrative department, the others are for the engineering department.ParticipantsWe recruited 29 office workers with LBP greater than 3 months. LBP due to specific injury or disease was excluded. The median age was 38 years, and 26 (90%) were male. All participants completed the study.InterventionsIn the intervention phase, participants performed WARP comprising frequent stand-up and individualised brief exercise/physical activity during work. Physical therapists held an LBP workshop and developed tailor-made programmes before introducing WARP. We instructed participants to perform WARP at five timings during work. Control phase was set before the intervention and participants stayed as usual.Primary and secondary outcome measuresThe primary outcome was pain intensity of LBP assessed using the Brief Pain Inventory. The secondary outcomes were work productivity loss measured using the Work Limitations Questionnaire, LBP disability assessed using the Roland-Morris Disability Questionnaire, psychosocial subscale assessed using the STarT Back Screening Tool and physical activity measured using triaxial accelerometers. These outcomes were collected at baseline and at 4-month follow-up evaluation.ResultsIn the intention-to-treat analysis, WARP did not show any significant effects on pain intensity (β, 0.01; 95% CI -0.50 to 0.52) and on the secondary outcomes. The median adherence to WARP was 28.6% (IQR, 16.8-41.1), which was equal to 1.43 times per day. No adverse effect was observed.ConclusionsThe present study was unable to confirm the effectiveness of active rest in improving LBP. Hence, further study needs to investigate its effectiveness.Trial registration numberUMIN000033210.

Project description:IntroductionIron deficiency is the most prevalent micronutrient deficiency in pregnancy globally responsible for nearly 120 000 maternal deaths per year and a fifth of maternal mortality. Over 46% of pregnant women in Africa and 62% of pregnant women in Kenya are anaemic. Anaemia has severe economic and health consequences. Daily iron and folic acid supplementation (IFAS) is an efficacious strategy recommended in pregnancy to reduce the risk of anaemia and improve maternal and neonatal survival. However, most pregnant women do not consume IFAS as recommended. Limited knowledge on IFAS, its benefits and its connection with anaemia, and mitigation of its side effects lead to poor consumption. The main objective of this trial is to determine the effectiveness of public health education on uptake of antenatal IFAS.Methods and analysisA stepped wedge cluster randomised trial with antenatal clinics as units of randomisation. Twelve clusters will be randomised to receive the intervention and levels of IFAS uptake compared with preintervention period. The 9-month trial will enrol 1205 pregnant women. The primary outcome will be the proportion of pregnant women effectively taking up IFAS measured through self-reports, residual pill count and inspection of pill reminder cards. Routine clinical data on haemoglobin counts and fetal growth monitoring will also be used. Descriptive and bivariate analysis will be conducted in Stata using Pearson's χ2 test for association, and multivariate logistic regression to identify determinants of uptake. The potential public health benefits will be estimated using the number needed to treat and the preventable fraction.Ethics and disseminationEthical approval was granted by Kenyatta University Ethics Review Committee (PKU/2443/11575). The research permit is obtained from Kenya National Commission for Science, Technology and Innovation (NACOSTI/P/22/16168). Findings will be disseminated through peer-reviewed publications and public health conferences.Trial registration numberPACTR202202775997127.

Project description:BackgroundDenmark has inferior cancer survival rates compared with many European countries. The main reason for this is suggested to be late diagnosis at advanced cancer stages. Cancer diagnostic work-up begins in general practice in 85% of all cancer cases. Thus, general practitioners (GPs) play a key role in the diagnostic process. The latest Danish Cancer Plan included continuing medical education (CME) on early cancer diagnosis in general practice to improve early diagnosis. This dual aims of this protocol are, first, to describe the conceptualisation, operationalisation and implementation of the CME and, second, to describe the study design and outcomes chosen to evaluate the effects of the CME.Methods/designThe intervention is a CME in early cancer diagnosis targeting individual GPs. It was developed by a step-wise approach. Barriers for early cancer diagnosis at GP level were identified systematically and analysed using the behaviour system involving capability, opportunity and motivation described by Michie et al. The study will be designed as a geographical cluster randomised stepped wedge study. The study population counts 836 GPs from 417 general practices in the Central Denmark Region, geographically divided into eight clusters. GPs from each cluster will be invited to a CME meeting at a certain date three weeks apart. The primary outcomes will be primary care interval and GP referral rate on cancer suspicion. Data will be obtained from national registries, GP-completed forms on patients referred to cancer fast-track pathways and GP-completed online questionnaires before and after the intervention.DiscussionTo our knowledge, this will be the first study to measure the effect of a theory-based CME in early cancer diagnosis at three levels: GP knowledge and attitude, GP activity and patient outcomes. The achieved knowledge will contribute to the understanding of whether and how general practice's ability to perform cancer diagnosis may be improved.Trial registrationRegistered as NCT02069470 on ClinicalTrials.gov.

Project description:The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals, general practitioners and municipalities. The disease management programmes assign a central role to general practice; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice. The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention.The study was a stepped-wedge, randomised, controlled trial among general practices in the Capital Region of Denmark. The intervention group was offered three one-hour visits by a facilitator. The intervention was semi-tailored to the perceived needs as defined by each general practice, and the practices could choose from a list of possible topics. The control group was a delayed intervention group. The primary outcome was change in the number of annual chronic disease check-ups. Secondary outcomes were: changes in the number of annual check-ups for type 2 diabetes (DM2) and chronic obstructive pulmonary disease (COPD); changes in the number of spirometry tests, changes in the use of ICPC diagnosis coding and patient stratification; sign-up for a software program for patient overview; and reduction in number of practices with few annual chronic disease check-ups.We randomised 189 general practices: 96 practices were allocated to the intervention group and 93 to the delayed intervention group. For the primary outcome, 94 and 89 practices were analysed. Almost every outcome improved from baseline to follow-up in both allocation groups. At follow-up there was no difference between allocation groups for the primary outcome (p = 0.1639). However, some secondary outcomes favoured the intervention: a higher reported use of ICPC diagnosis coding for DM2 and COPD (p = 0.0050, p = 0.0243 respectively), stratification for COPD (p = 0.0185) and a faster initial sign-up rate for the software program.The mixed results from this study indicate that a semi-tailored facilitator-based intervention of relatively low intensity is unlikely to add substantially to the implementation of disease management programmes for DM2 and COPD in a context marked by important concurrent initiatives (including financial incentives and mandatory registry participation) aimed at moving all practices towards changes in chronic care.ClinicalTrials.gov: NCT01297075.

Project description:BackgroundAbout 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs.MethodsA cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used.ResultsSixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p < 0.001 and aOR = 11.0, CI95 [4.6-26.4], p < 0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management.ConclusionA booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status.Trial registrationTrial registry identifier NCT01610817 (2012/05/30).

Project description:BackgroundMelioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand.Methodology/principal findingsFrom April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80-0.99, p = 0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43-0.68, p<0.001). However, the incidence rate of culture-confirmed melioidosis was not significantly lower (IRR 0.96, 95%CI 0.46-1.99, p = 0.66).Conclusions/significanceClear benefits of this multifaceted prevention programme for melioidosis were not observed. More compelling invitations for the intervention, modification of or addition to the behaviour change techniques used, and more frequent intervention may be needed.Trial registrationThis trial is registered with ClinicalTrials.gov, number NCT02089152.

Project description:BackgroundOlder people living in residential aged care homes experience frequent emergency transfers to hospital. These events are associated with risks of hospital acquired complications and invasive treatments or interventions. Evidence suggests that some hospital transfers may be unnecessary or avoidable. The Early Detection of Deterioration in Elderly residents (EDDIE) program is a multi-component intervention aimed at reducing unnecessary hospital admissions from residential aged care homes by empowering nursing and care staff to detect and manage early signs of resident deterioration. This study aims to implement and evaluate the program in a multi-site randomised study in Queensland, Australia.MethodsA stepped-wedge randomised controlled trial will be conducted at 12 residential aged care homes over 58 weeks. The program has four components: education and training, decision support tools, diagnostic equipment, and implementation facilitation with clinical systems support. The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will be used to guide the program implementation and process evaluation. The primary outcome measure will be the number of hospital bed days used by residents, with secondary outcomes assessing emergency department transfer rates, admission rates, length of stay, family awareness and experience, staff self-efficacy and costs of both implementation and health service use. A process evaluation will assess the extent and fidelity of program implementation, mechanisms of impact and the contextual barriers and enablers.DiscussionThe intervention is expected to improve outcomes by reducing unnecessary hospital transfers. Fewer hospital transfers and admissions will release resources for other patients with potentially greater needs. Residential aged care home staff might benefit from feelings of empowerment in their ability to proactively manage early signs of resident deterioration. The process evaluation will be useful for supporting wider implementation of this intervention and other similar initiatives.Trial registrationThe trial is prospectively registered with the Australia New Zealand Clinical Trial Registry ( ACTRN12620000507987 , registered 23/04/2020).

Project description:IntroductionAchieving a sustained improvement in hand-hygiene compliance is the WHO's first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness.MethodsThree year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation.Primary outcomedirect blinded hand hygiene compliance (%).ResultsAll 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). INTENTION TO TREAT ANALYSIS: Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001) in ITUs but not ACE wards, equivalent to 7-9% absolute increase in compliance. PER-PROTOCOL ANALYSIS FOR IMPLEMENTING WARDS: OR for compliance rose for both ACE (1.67 [1.28-2.22]; p<0.001) & ITUs (2.09 [1.55-2.81]; p<0.001) equating to absolute increases of 10-13% and 13-18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20]; p = 0.003 per completed form) but not ACE wards.ConclusionDespite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to personalised action planning produced moderate but significant sustained improvements in hand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention's effect in different settings.Trial registrationControlled-Trials.com ISRCTN65246961.

Dataset Information

Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial.

Publications

Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial.

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