|- candidate number||15914|
|- NTR Number||NTR4329|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-dec-2013|
|- Secondary IDs||80-83700-98-133053 ZonMw dossier number|
|- Public Title||De implementatie van de richtlijn voor lage rugpijn|
|- Scientific Title||A patient and professional based multimedial campaign as innovative implementation strategy to improve low back pain guideline adherence. A cost-effectiveness evaluation.|
|- Healt Condition(s) or Problem(s) studied||Low back pain (LBP)|
|- Inclusion criteria||- Patients who have visited their GP up to 3 months prior to inclusion and who have been diagnosed with non-specific low back pain (with or without radiation up to knee, without motor loss);|
- Aged 18 to 65 years;
- Acces to the Internet.
|- Exclusion criteria||- General exclusion criteria (severe comorbidity, malignancy);|
- Back pain with motor loss;
- Severe psychiatric disorders;
- Age less than 18 years;
- No access to the Internet.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-sep-2016|
|- Target number of participants||500|
|- Interventions||For patients: a multimedial informative e-health campaign to change back beliefs and attitudes.
For professionals: accredited medical continuing education in which interdisciplinary communication and cooperation and communication with patients with low back pain are addressed.
|- Primary outcome||Cognitions of patients regarding nonspecific low back pain measured using the Back Beliefs Questionnaire.
|- Secondary outcome||- Functional status of LRP patients, measured by the Roland-Morris Disability Questionnaire (RDQ-24);|
- Coping with pain LRP patients, measured by the Pain Coping Inventory;
- Quality of life of patients, measured by the EuroQol;
- The degree of care utilization and productivity losses (questions about illness and work) by non-specific LBP patients, measured by the TIC-P for adults;
- Professional guideline adherence, measured by performance indicators;
- Number of referrals to physiotherapy, medical specialists and second-line diagnostics and imaging because of suspicion of a somatic cause for non-specific LBP will be measured by referral registrations;
- Knowledge of and confidence in LRP management of GPs, measured by means of a newly composed questionnaire.
|- Timepoints||Baseline (T0), 3 months after baseline (T3), 6 months after baseline (T6), 12 months after baseline (T12).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Arnela Suman|
|- CONTACT for SCIENTIFIC QUERIES|| Arnela Suman|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Summary
BACKGROUND Low back pain (LBP) is one of the most prevalent and expensive public health problems in western society. In most cases LBP is nonspecific and will recover within three weeks. Despite global initiatives to discourage early diagnostic imaging for LBP, there is still a large number of ineffective and costly referrals, leading to chronicity, disability and medicalization. In 2010, in The Netherlands an integrated care guideline for nonspecific LBP was developed, focusing on improvement of patientsí beliefs and functional status and enhancing interdisciplinary coordination. This study evaluates the (cost)effectiveness of a patient and professional based implementation strategy (adapted from an effective Australian campaign) to implement this guideline in daily practice in The Netherlands.
METHODS In a longitudinal stepped wedge RCT the implementation strategy is compared to usual implementation of the LBP guideline. The strategy consists of an interactive and interdisciplinary training session for General Practitioners (GPs), physiotherapists (PTs) and occupational physicians (OPs), and a multimedia campaign for LBP patients. Participants are 30 GP practices with PTs and OPs from their network, and 500 LBP patients who visited their GP in the three previous months. The GPs, PTs and OPs are randomized in four clusters based on their region. Patients are included four times during the trial period of 16 months and are randomized according to their GP allocation.
RESULTS/CONCLUSION Primary outcome measure is patient beliefs about LBP. Secondary outcome measures on patient level are: functional status, pain coping, quality of life, interference of LBP with daily activities and societal participation, including paid work. Secondary outcome measures on professional level are: guideline adherence, referral rate for diagnostics/treatment, and knowledge of and confidence in LBP management. All outcome measures are assessed using questionnaires at baseline and after three, six, and 12 months (patients) and after three months (professionals). The cost-effectiveness analysis is performed from societal perspective. Costs of the implementation strategy, health care consumption and productivity loss will be measured, valued and analyzed. The study will start inclusion of participant in May 2014. First results are expected in 2015.|
|- Main changes (audit trail)|
|- RECORD||20-dec-2013 - 31-mrt-2014|