The care pathway designed for this trial proved to be an essential mechanism for operationalizing a model of integrative care. Providing the care team with a deliberately outlined process to follow, supported by standardized patient information and guiding principles, allowed them to consistently and effectively apply treatment plans. Additionally, the care pathway functioned as a detailed quality assurance system, which was useful in maintaining the integrity of study methodology across varied treatments. It is unlikely that the integrative team of providers could have provided consistent care without the structure provided by the care pathway; case managers were integral to reinforcing this process. The pragmatic design of this research study required a high level of communication and flexibility between participants, providers, case managers, and project managers. This is particularly true considering that one-third of participants receiving treatment from the integrative team were re-assessed over their course of care.
There are several potential explanations for what could be considered a large proportion of patients whose care plans were revised by the integrative team. It is possible that what were perceived by the care team as "optimal" treatment plans were not effective. Also, the benchmarks that served as a trigger for considering other treatment options may not have allowed adequate time for the intervention to result in improvement. This is complicated by the chronic and episodic nature typical of LBP, for which a 12 week treatment period may not be ideal. Identifying an optimal intervention period and benchmarks, and furthermore tailoring them to the individual, will require extensive future research. Alternatively, it could be argued that treatment for any chronic condition should remain fluid, and that making changes to a care plan is a key characteristic of maximizing clinical outcomes. As the study is ongoing, clinical outcomes in this sample have yet to be analyzed.
Steps taken in the design and evaluation of the integrative care group in this trial is consistent with the recommended framework set forth for the study of complex interventions[43
]. A "pre-clinical" phase explored the literature on treatments and integrative care models for LBP, for use as the theoretical basis to construct an optimal integrative care team. Modeling, or Phase I, explored best practices in clinical care to delineate components of care and inter-relationships amongst providers that could affect outcome. These were used to set parameters around clinical decision-making for the group and became shared guiding principles for treatment. The trial itself was a hybrid of Phases II and III, with attention paid to features of well designed clinical trials. The integrative arm, however, remained somewhat fluid in terms of type, frequency, and delivery of care, creating an intervention that could adapt to the dynamic and iterative needs of participants.
Taking patients' preferences into account during study treatment was intended to reflect best practices in care and approximate the role choice plays in clinical practice. The impact this had on clinical outcomes will be assessed in future study analysis through expectation and satisfaction questionnaires. Additionally, qualitative interviews were conducted to capture various aspects of patients' experiences with the clinical encounter, including what they liked and did not like about their care. These results will be considered when assessing the "success" of this integrative model, as well as informing modifications to the care pathway for use in clinical practice and future research study design.
The integrative care team continued to evolve over the course of the study, moving through recognized stages of team building: forming, storming, norming, and performing[31
]. While changes in group dynamics may be considered a limitation to the study design, it is inherent to any team; therefore, it is important to regularly monitor and address these changes throughout the life of the group. The integrative care team transitioned early into a "norming" phase of team building, and reached a point where they were comfortable recommending each other's therapies. Team members learned early how to strike a balance between being the "expert" with regard to their own disciplines and remaining open to, at times, conflicting opinions of other healthcare professionals. This contrast occasionally created a healthy tension but was managed with open exploration and discussion among team members under the guidance of the group facilitator. Conversely, group members' motivation to reach consensus may have resulted in a reluctance to disagree. Some team members appeared to be highly focused on harmony, at the expense of engaging debate and risking group discord.
Relatively few study participants selected medication as a preferred or desired treatment option. There are several possible explanations why individuals tended toward selecting acupuncture, massage, and exercise interventions instead. This study was conducted at a university that focuses on complementary and integrative healthcare; this context may have been seen as a safe and credible environment to try treatments outside of mainstream healthcare. Further, the study was an opportunity to receive treatments at no cost. Additionally, many participants were currently taking or had already taken medication for their LBP and may have felt that a medication consultation would not provide any additional help. The side-effect profiles of commonly used pain medication could have also discouraged participants from making this selection. Chiropractic care was also not commonly recommended to, or selected by, study participants randomized to the integrative care arm of the study. Considering chiropractic care alone was the comparison group treatment, it may have been seen as not "different enough" to use as a treatment option in the integrative care arm. Similar to medication, participants may have been interested in trying other complementary treatments that are considered to be more "alternative" to mainstream healthcare.
Cognitive behavioral therapy was the modality most often declined at the initial treatment consultation. Interestingly, it also was the most commonly added modality if additional care was determined necessary during the intervention phase of the study. The integrative care team often felt that participants who had been previously wary of CBT eventually became amenable to it, once a primary relationship with another clinician had been established.
The model of integrative care created in this study was based on identification of effective treatment options through a review of the research literature, and consideration of what therapies are typically accessible treatment options in the context of the study population. Most of the chosen treatment options were readily available at the site of the trial, located at a health sciences university clinic with access to complimentary and alternative healthcare practitioners, as well as a medical doctor. Two licensed clinical psychologists were added to the team to provide cognitive behavioral therapy.
A limitation of this study is the question of its generalizability. This idealized care pathway was created by study investigators to optimize a collaborative, non-hierarchical design. It operated outside the context of time, resource, and financial restraints that are practical realities of most healthcare environments. Further, this study was conducted in the U.S., where the delivery system and certification of providers is often different from other countries. Access to various types of care modalities and providers can be different depending on region, and may influence the ability to translate study results to other healthcare environments. On the other hand, the highly flexible and pragmatic design of integrative care in this trial may actually enhance its generalizability. This 'real-world' approach has been identified as a design option for phase III trials of complex interventions, which may have some advantage over a tightly standardized care plan. Of note, a deliberate description of elements and characteristics of the intervention are important for drawing conclusions about the intervention, and its application to a variety of clinical settings[43
]. It is important to acknowledge that the results of this trial will provide information on the efficacy of this specific model of integration only. While it does not represent the effectiveness of all integrative models in aggregate, this study does provide an important foundation for the development and implementation of future integrative models for back pain care.
From a delivery perspective, the financial feasibility of this or similar integrative care models must be considered alongside cost-effectiveness of patient outcomes. The breadth and scope of disciplines, weekly care team meetings, and facilitation by case managers resulted in a resource-intensive intervention. If clinical outcomes are positive, future investigation should explore which are the most essential elements of the pathway outlined in this study. Lessons from this study suggest established integrative teams, whose members can provide multiple types of therapy, access common patient information via electronic record systems, and anticipate responders to types of care, would likely contribute to financially viable models.