Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain

All patients complete a standardized screening on the same day as their first consultation at the clinic. Included in the screening are questionnaires about demographical and clinical characteristics, such as physical and mental health and employment status. If the screening was conducted more than two months earlier, the patient will be asked to complete the screening again to ensure reliable baseline data. No procedures related to the trial will take place before the baseline assessment has been completed.

The follow-up assessments will be conducted 6 and 12 months after randomization. The research coordinator will perform the follow-up assessments, and the location will either be at the clinic or the participant’s home, depending on their preferences. For the primary outcome (rate of competitive employment) we will also add a long-term follow-up collected through a brief phone interview at 24 months (Fig. 1).

Electronic data collected using tablets will automatically be transferred to and stored in a secure online database. Data collected on paper will be entered manually by the research coordinator, after which the original questionnaires will be destroyed. The information will be de-identified, and the identifier will be secured in a locked and fireproof safe.

The goal is to recruit 80 participants to the trial (see sample size calculations). Patients will be consecutively recruited and randomized at the Department of Pain Management and Research at Oslo University Hospital, Norway. All patients referred to the clinic eligible for participation will be informed about the study and invited to participate.

All clinicians, including the office staff, have been trained in the inclusion procedures and are able to inform and include patients during their consultations. Clinicians can also inform the primary investigator and/or the coordinator of the study about potential participants, who will then contact the patient by phone. Posters and brochures providing information about the study and contact information to the researchers are distributed throughout the clinic, allowing patients to make direct contact if interested.

Patients who want to participate will be informed of their rights according to the Helsinki declaration, receive additional information about the study, and sign a written informed consent before any trial related procedure takes place. The design of the trial will be explained to the patients in detail. For those included, baseline assessment and randomization will be performed.

IPS has traditionally been used for people with severe mental illness. However, the model has also been used for other populations, for example, people with post-traumatic stress disorder, spinal cord injury, traumatic brain injury, and autism spectrum disorder. In the Supported Employment Fidelity Review Manual [33] the authors specifically states that IPS units that serve other populations will connect with another set of service providers than mental health practitioners. Employment services in the current study are thus integrated with interdisciplinary pain treatment and not mental health treatment per se, although the interdisciplinary pain treatment can involve a psychologist.

Furthermore, the organizational model in the current study will include a NAV-coordinator located at the clinic with access to the data systems of all the local NAV offices surrounding the clinic. This position will serve as a supplement to the services provided by the employment specialists, and the position will mainly serve the function of a case manager. Case management in the United States emerged after the deinstitutionalization of patients from the major psychiatric hospitals. A case manager has a coordinating function and is responsible for assessing needs and implementing plans. Although a case manager initially had little direct contact with patients, the modern clinical case manager’s role includes both clinical and social work. In Norway, we do not have an equivalent to a clinical case manager position. Here, the clinical function is placed within the mental health services, and the social function at the local NAV offices. In the current study, we want the NAV-coordinator to serve both these functions. The coordinator will be the point of contact between NAV and both participants and treatment providers, and one of the primary tasks for the coordinator will thus be to give general advice on benefits and work incentives. Since patients referred to the clinic belong to a wide range of different NAV offices, we chose to make this adaptation in order to realistically be able to provide benefits counselling and work incentives planning. Another important task for the coordinator is to provide support to the participants when undergoing important changes in their lives regarding work. The coordinator has training in Motivational Interviewing (MI) and conducts regular meetings with the participants. Most of the meetings take place outside the clinic, often using assertive engagement and outreach in the participants’ community. This part of the coordinator role pertains to the clinical function of the case manager.

The sample size calculations are based on input-data from international IPS studies, which have shown a return to competitive employment rate of 23% for the control group and 61% for the IPS group [34]. Considering these rates to be plausible, each group will require 31 participants to reach a statistically significant difference (using a 5% significance level and a strength of 90%). However, as IPS has never been investigated in this patient group before, the effects found in this study may be more moderate than those found in earlier studies conducted with people with severe mental illnesses. A second possible scenario may be a return to competitive work rate of 23% for the control group and 55% for the IPS group, which would require 44 participants in each group. Given that both these scenarios are plausible, we aim to recruit at least 40 participants in each group.

The analyses will follow the “intention to treat” principle. The randomization will ensure that there are no systematic differences between the IPS and control group at baseline, both when it comes to observable as well as unobservable characteristics. We will compare proportions employed in each group, and investigate whether differences are statistically significant. Additionally, we will perform regression analyses using logistic regression models to investigate predictors of treatment outcome. Groups will also be compared on secondary outcome measures using survey data at baseline and 6 and 12 month follow-up.

Because IPS is provided in addition to TAU, the intervention is more costly than TAU alone. A health economic analysis will be conducted to investigate the differences in costs relative to differences in effect (e.g. competitive employment rates, hours of work, wage rates, etc.) between the groups. This is commonly referred to as the incremental cost-effectiveness ratio (ICER). The analyses will also include data on health-related quality of life as measured with the EQ-5D, allowing for an estimation of costs per quality-adjusted life-year (QALY).

The IPS fidelity scale is an established measurement to assess adherence to the IPS methodology [35], and fidelity evaluations will be conducted in the initial phase of the project (baseline) and every 6 months until recruitment is completed. The evaluations will be conducted by an independent and experienced evaluator adhering to the well-established Norwegian translation of the IPS fidelity scale [36], and will provide information on competence and methodology in conducting the intervention, as well as the frequency of contact and interaction with the participants. In the Supported Employment Fidelity Review Manual [37] it is recommended that at least two reviewers conduct fidelity reviews to increase reliability of the findings. The recommendations for the interviewing format is conversational rather than a structured interview. There are recommendations for sample questions for each fidelity item, organized by stakeholder groups, although not a complete set of questions to answer each item or subcriteria item. After the review the reviewers independently rate the project on the IPS Fidelity Scale and then conducts consensus scoring to compare ratings, resolve disagreements, and decide upon final ratings. There are, however, several challenges when conducting fidelity reviews this way. One is that reviewer competency can be low, especially in countries where IPS is relatively new, as in Norway, or where the raters are not calibrated with the originators of the model. Another challenge is the unstructured interview form, which makes it difficult to obtain high inter-rater reliability. In addition, the risk of low consistency between both reviews and reviewers due to the individual approach to interview questions and interpretations of answers and observations will always be present.

In the fidelity reviews for the current study we have thus chosen a slightly different approach that involves: 1) a reviewer with operational experience on all levels of IPS, training in doing fidelity reviews from the originators of the model, and calibration with The IPS Employment Center at The Rockville Institute, 2) a fidelity review tool with a matrix of 260 questions specifically developed to answer main items and subcriteria items in the IPS fidelity scale. The 260 questions will be distributed to seven different interview objects, three observational objects and two document objects. All questions are structured with answer options, eliminating the need for interpretation of each question; and 3) a digital scoring tool to avoid errors in scoring data transfer. We believe this will ensure higher reliability as well as consistency across fidelity reviews, with 50% less resources needed.

Any significant deviations from the IPS principles revealed by the fidelity reviews will be noted and communicated back to the employment specialists to ensure and increase quality.

Personal confidentiality is guaranteed for all participants. All data collected in the study is regarded as confidential, and the memory sticks and all data containing personal information will be securely stored in a fireproof safe.