Development of a theory- and evidence-based intervention to enhance implementation of physical therapy guidelines for the management of low back pain

We used the results of our multi method formative work to develop a synthesis of most important determinants. Subsequently, we organized our findings into a logic model of the problem of lack of guideline adherence highlighting the central roles of therapists and the practice quality managers (see Figure 1). This model was presented to and discussed with the members of the program planning team to check if the model actually covered the most important determinants.

Based on the guidelines, we described adherence with 12 individual indicators from the guidelines, they are: 1. assessing warning signs of the need for physician referral, 2. making a physician referral if needed 3. applying the ICF, 4. assessing a patient profile, 5. choosing examination objectives based on the profile, 6. creating treatment objectives based on the profile, 7. developing treatment strategies based on the profile; 8. determining maximum number of treatment sessions, 9. providing adequate patient information; 10. measuring outcomes, 11. arranging aftercare, 12. providing a written report to the referring physician [16].

We found the most important personal influences on physical therapists’ performance were paying attention to the guidelines, knowing content, feeling comfortable and certain about adherent care, perceiving guideline characteristics positively, expecting positive outcomes from adherence, having sufficient self-efficacy and skills to apply adherent care, having a positive social norm regarding adherence and experiencing little motivation to comply with patients who prefer non-adherent care. The personal determinants of the behaviour of quality managers were knowledge of quality management, commitment and a positive attitude towards high-quality care, positive social influences with respect to quality management, self-efficacy and skills with regard to management and monitoring tasks, and motivation and advocacy skills.

Environmental influences for the therapists included adverse social norm and barriers. The CPGs on low back pain were judged by some to lack credibility, to be incomprehensible, and to hamper clinical reasoning. Practice management characteristics included inaccurate quality management, unfavourable practice culture, and lack of monitoring. The professional association was seen as not providing sufficient facilitation and as lacking a clear and consistent policy with regard to guideline implementation. Patients also play a significant role in the environment of therapists’ adherence when they lobby for hands-on and extended care. These demands were related to patients’ inadequate understanding of the natural course of low back pain, inappropriate expectations of the physical therapy treatment, and insufficient information about the role of psychosocial factors.

Following the Intervention Mapping framework, we completed the following program development steps based on our formative findings. The project team focused the intervention on two interacting practice levels: private practice physical therapy and practice quality management. Due to issues of quality control and quality certification by health insurance companies, there is a growing tendency in Dutch physical therapy practices to make one of their colleagues responsible for quality management.

In the first three months of the Intervention Mapping process, we created matrices of change objectives. Change objectives combine the expected performance of our two groups of proposed intervention participants, physical therapists and quality managers, with determinants that describe influences on performance. We based the performance objectives on the effect of the practice level (quality manager behaviour) on physical therapist adherence; the 12 quality indicators that reflect guideline adherence; formative findings regarding the importance of clinical reasoning (dealing with psychosocial factors, using outcome measurement instruments, and recording patient data) and a guiding theory of individual and organizational learning self-regulation (self-reflection, self-judgment, goal setting, planning and action) [19, 20].

Based on the change objectives, we used the next 3–4 months to match theory-informed intervention methods to the change objectives for therapists and managers and to formulate practical applications. An intervention method (also referred to as behavior change technique [21]) is a theoretically and empirically supported process for effecting behavior change in individuals, groups, or social structures. A practical application is the way a method is delivered to match the context of the priority population.

An overview of methods and applications with reference to the theories from which they are derived is presented in Table 3. For example, from Goal Setting theory [22], we asked physical therapists to formulate goals that were challenging, moderately complex, specific, measureable, realistic and acceptable. In order to increase the likelihood of goal attainment, in addition, participants added specific plans (implementation intentions) for carrying out their goals [23].

From the beginning of the planning process, we paid attention to capacity for the program’s adoption, implementation and sustainability, including its practical acceptability and feasibility throughout development. The plan components to facilitate adoption, implementation and sustainability were directed at policy of the professional association to bring a focus on quality improvement; information for the patient to discourage seeking hands-on treatment and to increase awareness of the importance of psychosocial factors in low back pain; revision of the guidelines to increase support for clinical reasoning and for dealing with psychosocial factors; regular inclusion of our program in nationwide training programmes.

The evaluation plan concerned the pilot test of the quality improvement program. Aims of the evaluation were to assess the potential effectiveness of the program as well as to evaluate the fidelity, acceptability and feasibility of the program’s implementation in an accompanying process evaluation.

For the effect evaluation, we planned a one-group pre-test/post-test study (N = 8 practices, including 30 physical therapists 8 of whom were also the quality managers of the practices). We measured adherence to the CPGs on low back pain with clinical vignettes that addressed the previously mentioned 12 indicators reflecting the guidelines’ main recommendations. These vignettes were based on validated vignettes from a previous study, which showed to have acceptable validity (Spearman’s rs = .31) to measure PTs’ guideline adherence [37‐39]. Clinical reasoning was measured by assessing the consistency of physical therapists’ choices over three separate quality indicators. Consistency in choices was operationalised as the presence of the conditional argument” (if-then connective) which is an important component of human reasoning [40] (e.g. if the therapist found psychosocial factors that influence the course of recovery, than he should integrate them into the treatment plan). We measured changes in practice quality management with observations, group interviews, and document analyses, with a focus on self-regulation, commitment to quality management, transfer of knowledge to the practice, patient recording, regular deliberation meetings, patient outcome measurement, monitoring systems, and structures for sustainability. Further details as well as the results of the evaluation study are written elsewhere [16].

The process evaluation was an observational study of fidelity, acceptability and feasibility. Concerning fidelity, evaluation addressed whether the implementation addressed the planned behaviours, methods and practical applications, performance objectives and change objectives, program components and activities previously specified. We also assessed the extent to which physical therapists and quality managers participated in activities. Regarding acceptability we asked the participants’ to evaluate the intervention and materials used. Feasibility questions addressed potential barriers, such as time and financial limitations.

This study demonstrates how the framework of Intervention Mapping can be used to develop interventions that aim to improve guideline adherence based on formative research. Findings from multi-method formative research provided the foundation for a logic model of the problem of physical therapists’ low adherence to clinical guidelines for low back pain. This logic model enabled the planners to first decide “who” and “what” should change as a result of the intervention. From the formative work, we decided that the intervention should influence both therapists and managers at the practice level and that these participants should actively plan and implement practice change through a process of self-regulation with therapists monitoring and analysing personal adherence, setting goals for improvement, implementing plans and evaluating outcomes. Quality managers were taught to plan and implement change at the practice level.

Based on the findings from the formative work regarding the behaviours necessary to implement clinical guidelines and the influences on behaviour at both the therapist and practice levels, we produced matrices of change objectives, the guiding documents for program development. The change objectives pointed to the selection of theory-informed behaviour change methods and practical applications and, finally, to the creation and delivery of a coherent program.

To systematically develop a multilevel intervention using the Intervention Mapping framework presented some challenges. We were surprised at the analysis needed and the lack of clear guidance for how to sort through the formative findings to select the most important performance objectives and behaviours for both the therapist and the practice levels. The formative data, including literature review, did not (and usually does not) provide clear evidence of causation - either about what people should do to reach the behaviour change targeted by the intervention, nor why they would engage in the performance when specified. For example, from the survey we found that almost 80% of the participating physical therapists were inclined to follow the patient’s preferences. This suggested to us that motivation to comply may be a salient determinant of guideline adherence, but the relation certainly could not be depicted as causal. Nevertheless, this partial evidence is generally the state of the knowledge, in terms of developing interventions and adapting evidence-based interventions to new settings. We would argue that an imperfect systematic process of selecting and using information about behaviours and determinants is much better than simply avoiding the evidence altogether. Several selection procedures have been described by other researchers [41‐43], but to our knowledge no consensus exists about a preferred procedure.

A second challenge was related to the selection of theory-based behaviour change methods and practical applications. Although many theories postulate how change in behaviour may occur, the evidence for the underlying assumptions is still under development [5, 21]. A recently developed model by Michie and colleagues (2011) that links behavioural conditions (that can be seen as determinants) to intervention strategies and policy categories [44] has not yet been extensively evaluated. The Intervention Mapping developers have also provided a series of tables that make suggestions and provide evidence for change methods that are matched to specific determinants and supported by examples and evidence [13]. Nevertheless, thinking about what methods might be both feasibly delivered and powerful enough to produce change can be daunting, and at this time combines both creativity and evidence.

A third issue arised while developing the intervention program. Preferably, this program would adequately address all selected determinants for optimal change [5, 21]. This goal must be carefully balanced with acceptability and feasibility of the program. This tension may result in ineffective programs that are either too ambitious or too superficial, and is therefore another point in the planning process where formative work can be informative. For instance, our consideration to enable physical therapists to implement their guidelines within an acceptable time investment made us decide to use self-regulation. Another difficulty is that applying Intervention Mapping in program development is an iterative process so that program developers must have a certain degree of flexibility to learn from formative data, listen to the advisory committee, and backtrack as necessary.

Finally, the foregoing issues raised, indicate that thoroughly going through each step of Intervention Mapping may be a time consuming, and therefore costly process. It is indeed our opinion that familiarity and experience with the Intervention Mapping procedure may be a great advantage in this respect. The process may further benefit from sound planning based on anticipation on the subsequent steps. This can reduce the likelihood of unforeseen developments and too much backtracking, and consequently of the required time investment.

A positive, but challenging aspect of guidance provided by Intervention Mapping is that interventions be focused on various levels of the ecological model. In our case, this meant targeting both individual behaviour and practice level elements. We developed an intervention for guideline adherence of physical therapists, a factor that can be considered to be an environmental influence for patient behaviour and health outcomes. We also addressed quality managers, a group in the practice environment of the therapists. Our formative studies revealed several factors related to inadequate practice quality management that negatively influenced physical therapists’ guideline adherence. Although targeting these multilevel influences on low back pain care complicated our selection of behaviours, determinants, change methods and ultimately program components, our formative work provided us with a sound rationale for the development of our program.

The study was approved by the Committee on Medical Research Involving Human Subjects (CMO) Arnhem-Nijmegen (Filenr. CMO 2007/172).