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In this multicenter randomized controlled trial, the aim is to evaluate the effectiveness of a standardized treatment pathway (STP) for patients referred to four participating pain clinics, by comparing it to treatment as usual (TAU) which is standard care at the clinics.
The STP differs from TAU in two key aspects:
The study aims to answer whether the STP give larger improvements than TAU in the following outcomes:
All study participants will follow an initial care pathway at the pain clinic, which includes:
The control group:
This group will receive standard care at the pain clinic. This will vary somewhat between the four pain clinics , but almost all patients will be offered a summary consultation with the pain clinic team where further plans for follow-up will be discussed. Some patients will be offered further treatment at the pain clinic.
All clinics will send a clinical summary to the referring physician with suggestions for further follow-up. If further collaboration with primary care is needed, it may preferably be written or arranged via telephone. Digital collaborative meeting will not be offered to this group.
The intervention group:
All patients in this group will be offered the STP with two digital collaborative meetings as described above.
Full description
A new standardized treatment pathway (STP) has been developed by the Pain Research Group at St. Olav's Hospital. The STP is designed to establish structured collaboration between specialist and municipal health services, as well as the Norwegian Labor and Welfare Administration (Nav). In this study, the STP will be compared to the current standard of care, which typically involves multidisciplinary clinical assessments followed by a summary consultation between the pain clinic and the patient.
The key innovation of the STP lies in its cross-sectorial collaboration, most notably the inclusion of the patient's general practitioner (GP) in two structured video consultations with the patient and the multidisciplinary pain clinic. When relevant, a Nav representative or representatives from municipal and specialized health service may also participate. A collaborative treatment plan is developed during the first video consultation and reinforced through a six-month follow-up period, culminating in a second collaborative consultation.
Given that the STP is more resource-demanding than current practices at Norwegian pain clinics, involving coordinated efforts across multiple sectors, it is crucial to evaluate its overall effectiveness. Equally important is identifying which patient subgroups may benefit most from this approach, to ensure that resources are allocated efficiently and care is tailored to those with the greatest need.
The primary aim of this study is to evaluate the effectiveness of the STP for patients referred to one of four participating pain clinics, by comparing it to TAU in a randomized controlled trial.
Hypotheses, aims and objectives:
The primary aim of this study is to investigate if patients with chronic pain admitted to a pain clinic and who receive a new collaborative STP will have larger improvements in overall impression of change in health and pain interference compared to patients who receive TAU.
Hypotheses: Compared to the control group, we hypothesize that patients in the intervention group will report:
H1) less pain interference H2) better overall change in health
The secondary aims of the study are to compare collaborative STP with TAU in terms of:
Aim 1: physical functioning Aim 2: mental health Aim 3: participants' experience of continuity and integration of the health care services Aim 4: participants' satisfaction with the health care services and social security services Aim 5: prescriptions of opioids and other potentially addictive medication Aim 6: use of primary and specialist health care Aim 7: return to work and decisions from Nav Aim 8: referring GPs' satisfaction with the pain clinic management
Hypotheses (for secondary aims): Patients in the intervention group will have/report:
Project methodology:
This is a multi-center study that will include patients with chronic and complex pain undergoing treatment at one of four multidisciplinary pain clinics in Norway: St. Olav's hospital, Haukeland University hospital, University hospital in Northern Norway and Innlandet Hospital.
Design:
The study is a two-group randomized controlled study comparing a new collaborative STP with usual care at four multidisciplinary pain clinics. Each clinic will randomize their patients into an intervention group (collaborative STP) and a control group (TAU).
Study sample:
A total of 386 patients will be included in the study (see sample size estimation).
Inclusion criteria:
Patients aged 18-80 years with an accepted referral for multidisciplinary care by one of the four pain clinics.
Exclusion criteria:
Patients referred for monodisciplinary care are not eligible for this study. Participants who are unable to perform the required tasks or procedures necessary for participation in the study will be excluded. These tasks include, but are not limited to, completing questionnaires that, due to technical reasons, are available only in Norwegian language, and being capable of participating meaningfully in collaborative meetings as assessed by clinical professionals.
Additionally, patients who have already undergone a mapping consultation (see next section) and have been deemed ineligible for further follow-up at the pain clinic will also be excluded from participation.
Inclusion, informed consent and randomisation:
Initial information:
All patients who meet the admission criteria for multidisciplinary care at the pain clinic will receive a general admission letter with information about the clinic and the scheduled times for clinical consultations. Patients who are eligible for the study will receive a separate letter containing written information about the study.
In order to find eligible patients, we applied to the Regional Committee for Medical and Health Research Ethics (REK) and the study was given an exemption from the duty of confidentiality. This exemption will allow digital distribution of study information to patients, based on data extracted from their medical records.
All personal data related to individuals who do not consent to participate, do not attend the screening consultation, or do not respond to the invitation within three weeks will be deleted continuously and without delay.
The study information package will include:
This information will be sent digitally via the secure platforms "helsenorge.no" or "HelsaMi"
Patients will be given the following options:
In some cases, the clinic may require additional information before confirming eligibility for care. These patients will be scheduled for a digital screening consultation with a clinician. Only those admitted to further contact with the clinic will proceed to the screening consultation.
The study coordinator's screening consultation:
Before the first clinical consultation, eligible patients will be contacted by a study coordinator via telephone and invited to a screening consultation, scheduled at least one week after the initial information package to allow time for consideration.
During the coordinator's screening consultation:
Finally, participants will be randomized using the digital randomization system provided by eFORSK. The randomization will be stratified according to clinic. A block randomization method with permuted blocks of random sizes (e.g. 4 to 8 subjects) will be used. The allocation ratio between the intervention and control groups will be 1:1.
The intervention and the control group:
All study participants will follow an initial care pathway at the pain clinic, which includes:
The control group
Participants in the control group receive standard care at the pain clinic, which includes:
Primary care representatives do not participate in the summary consultation for the control group. A clinical summary is sent to the referring physician (most commonly patient's general practitioner) detailing either the planned treatment at the pain clinic or recommendations for further follow-up in municipal health services or other specialist healthcare services. If further collaboration with primary care is needed, it may preferably be written or arranged via telephone.
The intervention group: Standardised Treatment Pathway (STP) Participants in the intervention group receive a similar initial care pathway as the control group, including the screening consultation and multidisciplinary clinical evaluation, in accordance with the National Pathway for Chronic and Complex Pain Conditions.
The intervention consists of three steps:
Patients and their GPs will be informed as soon as they are randomized to the intervention group about the intervention. This will be done by a separate information sheet to the patients, and a letter with general information to the GP about the study and suggested time and date for the first collaborative consultation. Following this, the intervention group gets the multidisciplinary clinical assessment and engages in a pre-planned digital collaborative consultation arranged by the pain clinic. This consultation includes:
During the consultation, a comprehensive treatment plan is developed collaboratively, covering a six-month follow-up period. This plan may include:
Statistical analyses The primary analysis will estimate difference in either means or proportions with 95% confidence interval (CI) between the intervention and control groups over the first 6 and 18 months. The analyses will be conducted according to the intention to treat principle using a linear mixed model for differences in means and generalised estimating equations (GEE) for differences in proportions. In the mixed models, correlation between repeated observations within individuals and correlation between patients having the same GP are accounted for by specifying random effects.
The effect of the intervention and time will be specified as fixed effect using a joint variable of intervention and time. Here, baseline levels are pooled over the two study groups assuming that any baseline differences are due to chance. In the GEE models, correlations between repeated observations between individuals are accounted for by specifying a correlation structure. The effect will be estimated both crude and adjusted for study center, which will be used to stratify the randomisation, as well as other important prognostic factors (e.g., age, sex, educational level and clinical characteristics).
Missing values are inherently accounted for in the GEE and mixed model approach by including all available information, but multiple imputation methods and complete case analysis will be applied in sensitivity analyses. Additional protocol analysis will be specified in the statistical analysis plan for the trial. The decision on which variable to inform on adherence is guided by experience from the feasibility study. Stratified analyses of the primary outcome will be performed as secondary analyses. Analyses may include stratification for gender, age-groups, socioeconomic status, etc.
Most secondary outcomes will be analysed using a similar approach as described for the primary outcome with linear mixed models. Time to sustainable return to work will be analysed using Cox regression.
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Inclusion criteria
Patients aged 18 years or older who have been granted the right to specialist health care in accordance with the Norwegian National prioritization guideline for pain clinics, and who are scheduled for multidisciplinary treatment involving at least two professionals from the pain clinic.
Exclusion criteria
Patients scheduled for monodisciplinary treatment. Patients referred solely for invasive procedures. Patients without sufficient language skills to understand the study information and provide informed consent. Patients are excluded if interpreter services are required.
Patients deemed unable to complete study-related tasks (e.g., questionnaires). Patients referred exclusively for stabilization or tapering of opioids or other medications considered addictive.
Patients who will be unable to participate in collaborative meetings or follow the treatment plan due to extensive ongoing or planned care trajectories within other specialist health services.
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386 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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