Evaluation of the Implementation of PED-t in a Naturalistic Setting
Condition: Bulimia Nervosa; Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

Summary: 
      The Eva-PED-t project will evaluate implementation of a new therapy for eating disorders,
      called PED-t (Physical Exercise and Dietary therapy), in a new treatment arena for such
      illnesses. By this, Eva-PED-t evaluates effectiveness- and efficacy outcomes, with the latter
      highlighting both the user-, the therapists- and the management perspectives. The research
      group behind this initiative comprises the founders of the PED-t, and holds extensive
      expertise on research methodology, eating disorders, health science, and exercise medicine,
      affiliated high-ranked research-intensive universities. Previous documentation of poor
      implementation of evidence-based knowledge in public health services reveal poor or no
      translation of new research findings for improved screening, treatment or medical procedures
      into real life settings. This may impair public health service outcomes, as less effective or
      ineffective treatment or procedures are routinely preferred. In a randomized controlled
      trial, the Eva-PED-t partnership recently found a new therapy for eating disorders (PED-t) to
      be comparable effective to the currently recommended treatment (NCT02079935). Specific
      advantages with PED-t, are the use of professionals not currently used in therapy of mental
      disorders, and the efficiency of arranging therapy in groups, hence effectively dealing with
      the high request for therapy. The Eva PED-t collaborative is motivated by the knowledge of
      high prevalence of mental illnesses, for which there is a need to improve treatment access
      and -efficiency. Adding to this scenario, is the new and more prevalent diagnosis of eating
      disorders, binge eating disorder, for which specialized health services have no
      prioritization for treatment. Addressing requirements for improved therapy access demands
      investigation of new treatments and new ways of delivery. The PED-t responds to this request,
      still recommendation for a broad implementation necessitate exploration of implementation
      strategies and experiences.
    

Detailed description: 
      Implementation research intends to identify facilitating and obstructing elements in the
      process of transferring evidence-based practices from controlled settings to naturalistic
      settings. Unfortunately, the implementation of evidence-based knowledge is challenged by lack
      of institutional resources and insufficient prioritization by the management, and lack of
      prioritization by funders and academic researchers. As such, a lag time before evidence-based
      knowledge from research is translated in to real world practice is typically estimated to be
      about 14-20 years. The delay in implementation of evidence-based practice is found to be
      specifically relevant in health care services, hence, ultimately depriving patients from best
      practice. Exercise referral centers (ERC, also known as Healthy Living Centers) are part of
      the municipally public health care, providing support for improved healthy living behavior.
      Service users are confident by the professional skills in the ERC, and trust the service to
      be evidence-based. However, there are a wide variety in program approaches and methodology,
      most with no evidence-based foundation, and a lack of documentation on effects. Hence
      originally, the UK National Institute for Health and Clinical Excellence (NICE) recommended
      not to commission ERC in primary health care other than in well-designed research studies.
      The ERC's are in an early progress, still exploring their role in public health care and
      having stakeholders requesting evidence-based methods, and as such, identification of
      successful interventions at the ERC's is necessitated.

      The Eva-PED-t has the potential to pick up on the shortfalls in documentation of
      effectiveness outcomes and exploration of efficacy of evidence-based interventions at the
      ERC's, and the poor implementation of evidence-based treatment in public health services in
      general. The EVA_PED intend to evaluate the implementation of the PED-t in the public health
      care services ERC in terms of effectiveness and efficacy, and by a mixed methods design. By
      relying on the original team behind the development of the PED-t to train the therapists,
      inform and supervise the management, and to provide support during implementation, this
      project has the potential to ease the implementation process. As such, the EVA-PED aim to
      follow the request to evaluate the total implementation success (i.e. the sum of the
      effectiveness of treatment and the experiences of implementation within the organization).

      The researchers behind the EVA-PED finalized the evaluation of effectivity from PED-t on
      treatment of eating disorders in 2018 (NCT02079935), bringing optimism on increased therapy
      access, lowering barriers for treatment seeking behavior, and facilitating a more effective
      treatment delivery. Having the PED-t research team initiating Eva-PED-t, this project will
      bypass the delay in translation of evidence-based knowledge to real life settings. The
      Eva-PED-t has the potential to identify any elements undermining optimal uptake of this
      evidence-based treatment in public health services. Informed on previous challenges on
      successful implementation of evidence-based procedures, Eva-PED-t grasp on these most
      critical elements. Providing practical training and adequate time for preparations, mentoring
      during therapy operation, relying on therapy elements similar to what the therapists have
      practiced in their regular work, and by communicating, involving and motivating several
      levels in the organizations (management and therapists); the EVA_PED target the most critical
      elements previously found to impair successful implementation. Additionally, by involving
      former patients and therapists from the PED-t intervention as user groups, combined with the
      findings from in depth interviews in the corresponding groups of patients and therapists, the
      EVA-PED will evaluate adjustments of the therapy and arrangement according to their
      experiences and advices.

      The EVA-PED-t project aims to evaluate the success of adopting and operating the
      evidence-based PED-t in naturalistic settings like ERC's, physiotherapy clinics and
      multidisciplinary medical centers. By this, the project intends to study effectiveness
      outcomes and efficacy outcomes, with the latter highlighting both the user perspectives, the
      therapists- and the management perspectives. A part of the efficacy outcomes, is evaluation
      on the treatment fidelity by individual therapists.

      This generate the following main- and secondary research questions (RQ):

      Main RQ:

      1. Which elements promotes or discourages the implementation of PED-t according to; a) the
      therapists, and b) the management at the therapy cites?

      Secondary RQ's:

        1. How well is the implementation quality concerning treatment fidelity in a naturalistic
           setting?

        2. What are the experiences amongst the patients receiving PED-t in a naturalistic setting?

        3. How effective is the PED-t in a naturalistic setting, evaluated in remission from
           diagnosis, in rating of quality of life, in intensity of symptoms for depression,
           anxiety and symptoms of an eating disorder, and in changes of eating- and exercise
           behavior?
    

Intervention name(s): Physical exercise and dietary therapy (PED-t); Implementation program for PED-t in ERC
Intervention type(s): Behavioral; Procedure
Intervention description(s): Behavioral therapy: Physical exercise and dietary therapy (PED-t) is a treatment of bulimia nervosa and binge eating disorder, relying on guided, progressive resistance exercise therapy and dietary therapy (dietary education and group discussions) following a designed therapy manual.; Participating in a training program for therapists in PED-t; to increase knowledge of eating disorders and to be able to implement and run the PED-t. Training program consists of a therapy manual, digital lectures, and 3 work shops.
Other intervention name(s): PED-t; FAKT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Employees and management in a ECR receive training in PED-t, and successively arrange the therapy. Experiences with the program training, and expectations to and experiences from giving the therapy, are the main research questions. Managements will be interviewed according to experiences with management of- and suitability of the therapy in the ECR
Eligible participants with bulimia nervosa or binge eating disorder are recruited for therapy in the ECR. Their expectations to- and experiences from having therapy in the ECR are the main research questions, in addition to evaluation of therapy success.
A previous RCT has evaluated the treatment efficiency by comparing it to a control group and another standardized treatment intervention. As such, the main focus of the current study is to evaluate experiences from arranging PED-t in a naturalistic setting, and secondly to evaluate if treatment efficiency can be replicated.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: remission; treatment; therapy; physical exercise; dietary therapy; diet; physical activity; naturalistic; Exercise referral centers; Healthy Living Centers; eating disorders; implementation