NETWORK PAIN REHABILITATION LIMBURG|
|- candidate number||27762|
|- NTR Number||NTR6654|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-aug-2017|
|- Secondary IDs||Adelante NL 17N133|
|- Public Title||NETWORK PAIN REHABILITATION LIMBURG|
|- Scientific Title||FEASIBILITY STUDY NETWORK PAIN REHABILITATION LIMBURG|
|- hypothesis||We hypothesize that Network Pain Rehabilitation Limburg will be feasible in daily practice based on the found barriers and facillitators and perceived quality of care. Moreover, the effect of the different treatments on the physical functioning of the chronic musculoskeletal pain (CMP) patients will be experienced positive. |
|- Healt Condition(s) or Problem(s) studied||Chronic pain, Rehabilitation, Musculosceletal pain|
|- Inclusion criteria||Inclusion criteria healthcare specialists|
Healthcare specialists who participate in Network Pain Rehabilitation must meet all of the following criteria:
• Having a practice in the pilot area of Pain Network Rehabilitation Limburg
• Willingness to attend the education days
• Willingness to treat patients with CMP via the stepped care musculoskeletal pain rehabilitation protocols
• Willingness to make use of the provided assessment tool when a patient suspected of CMP visits the specialist
• Physiotherapists without a participating GP can only treat patients referred from a RP. As they cannot refer a patient back to a GP when the patient is too complex for them they will not have an inclusion option for study participants.
• GPs can only participate when a linked physiotherapist, remedial therapist or a practice nurse mental health participates as well. This to make effective referrals to specialists who work with the protocols of Network Pain Rehabilitation Limburg possible.
Inclusion criteria patients with CMP
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
• Age 18-70 years at the start of the study
• Patient living in the pilot area (physiotherapist, GP or RP) of Pain Network Rehabilitation Limburg
• Having musculoskeletal pain with is (suspected to be) chronic. The patient has visited the physiotherapist, GP, or RP several times with the same complaints or is known with musculoskeletal pain in the history.
• Willingness to improve functioning despite pain
• Adequate Dutch literacy to complete the assessments (which mainly comprise questionnaires)
|- Exclusion criteria||Exclusion criteria healthcare specialists|
Healthcare specialists who meet any of the following criteria will be excluded from participation in Network Pain Rehabilitation Limburg:
• A GP who has visited less than 2 out of 3 education days or a remedial therapists who has visited less than 3 out of 4 education days.
• Are not able to implement the protocols or assessment tool of the network.
Exclusion criteria patients with CMP
A potential patient with CMP who meets any of the following criteria will be excluded from participation in this study:
• Any suspicion of a medical (orthopaedic, rheumatic or neurological) disease, which can explain the current pain (eg. Rheumatism and hernia) complaints and which can be threatened by a sufficient therapy
• Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the GP and RP
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2017|
|- planned closingdate||1-okt-2018|
|- Target number of participants||100|
|- Interventions||protocolized evidence-based musculoskeletal pain rehabilitation treatment plans, Pain Rehabilitation Coach, assessment tools, integrated in the current care, no comparison group.|
|- Primary outcome||To explore the feasibility of Network Pain Rehabilitation Limburg first a pilot study will be performed. This pilot study will focus on the barriers and facilitators of the implementation strategy and network structure, perceived quality of care, and the effect of the Network Pain Rehabilitation Limburg at daily functioning and participation in chronic musculoskeletal pain (CMP) patients. |
|- Secondary outcome||The barriers and facilitators regarding the implementation strategy, assessment tools, treatment protocols, and Pain Rehabilitation Coach will be determined with the use of focus groups. |
Also the quality of care regarding the implementation strategy, assessment tools, treatment protocols, and Pain Rehabilitation Coachaspects, will be determined during these focus groups.
The effect of the Network at the rehabilitation healthcare will be measured as two components: 1) as the effect at the referral pattern of patients with CMP in terms of efficiency and number of incorrect referrals, 2) and the effect on patient’s CMP and health outcomes.
|- Timepoints||Healthcare specialists:|
4 education days before 1 October 2017
3 focusgroups (November 2017, February 2018, June 2018)
2 questionnaires regarding referral pattern: June 2017 and February 2018
Patients with CMP:
T0 Questionnaire after referral
T1 Questionnaire: only for patients referred from a General practitioner to a rehabilitation physician. After the referral of the General Practitioner.
T2 Questionnaire: at the end of the treatment. This will depend of the choosen treatment for the patient.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Cynthia Lamper|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Ivan P.J. Huijnen|
|- Sponsor/Initiator ||Adelante Zorggroep|
(Source(s) of Monetary or Material Support)
|VGZ, CZ zorgverzekeringen, Zilveren Kruis|
|- Brief summary||Rationale: In the Netherlands, the currently used rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not transparent because of the lack of evidence based guidelines for treatments matching the level of complexity of each chronic pain patient. Additionally, it is unclear if treatment options used are effective and efficient. Moreover, the costs for chronic pain rehabilitation are high. It is plausible that the effectiveness of the rehabilitation care for patients with CMP can be improved when the care is organized in a network with a stepped care approach and assessment tools to support the decision-making of the healthcare professional are used. In this Network, every patient receives an individual treatment program based on this/her complexity of pain related disability. |
Objective To get an impression about the feasibility of Network Pain Rehabilitation Limburg, first a qualitative pilot study will be performed. This pilot study will focus on the barriers and facilitators of the implementation strategy and network structure, perceived quality of care, and the effect of the Network Pain Rehabilitation Limburg at daily functioning and participation in CMP patients.
Study design: A pilot study with an iterative and incremental design will be conducted. In three phases, nine physiotherapists, six GPs and two RPs with surrounded healthcare specialists, all situated in region Parkstad, will be participating in the Network Pain Rehabilitation Limburg. In phase 1 (start of the project till 1 October 2017) exploration of context will take place in order to develop the design of the Network and to educate the involved healthcare specialists. Next, in phase 2 (1 October 2017 till 1 March 2018) specification of content will be the focus. The design of the Network will be adjusted to daily practice. In phase 3 (1 March 2018 till 1 November 2018) the focus will be on the organization of care and reporting.
Moreover, a pre-post test design will be conducted to investigate the effect of Network Pain Rehabilitation Limburg at the pain problem of approximately 100 patients with CMP.
Study population: Healthcare specialists situated in the region Parkstad (South Limburg) who want to participate in Network Pain Rehabilitation Limburg. In addition to the healthcare specialists, adults aged 18 to 70 years old who visit the participating physiotherapists, GPs, or RP with CMP will be invited to participate in this study.
Main study parameters/endpoints: The barriers and facilitators regarding the implementation strategy, assessment tools, treatment protocols, and Pain Rehabilitation Coach will be determined with the use of focus groups. Therefore, healthcare specialists are asked to participate in 3 focus groups in each phase of the study. Moreover, a sample of patients will be asked to participate in a focus group at the end of the study. This information will be used to evaluate the feasibility of the Network and if required to adjust the Network for further research.
Also the quality of care, at the earlier mentioned aspects, will be determined during these focus groups. In addition to the focus group for patients, all patients will receive questionnaires about their satisfaction with the Pain Rehabilitation Coach. Regarding the quality of the referral and the treatment itself, patients will receive after referral and at the end of the treatment program an additional questionnaire. In addition, patients referred by a participating GP to a participating RP will receive an additional questionnaire regarding the quality of the referral of the RP.
The effect of the Network at the rehabilitation healthcare will be measured as two components: 1) as the effect at the referral pattern of patients with CMP in terms of efficiency and number of incorrect referrals, 2) and the effect on patient’s CMP and health outcomes. Therefore, healthcare specialists will receive a questionnaire regarding the referral pattern at that moment before the implementation of the Network and after the implementation. Patients will receive questions about anxiety and depression, and catastrophizing in order to compare their level of complexity with their referred treatment. The effect at patient’s CMP will be measured with questions regarding daily functioning (activities, disability, work participation, and pain intensity).
|- Main changes (audit trail)|
|- RECORD||18-aug-2017 - 7-okt-2017|
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