BackgroundThere is a lack of evidence concerning the effectiveness of different strategies to engage healthcare professionals in collaborative processes that seek to optimise clinical practice. The PREDIAPS project aims to assess the effect of different primary health care (PHC) providers’ engagement procedures in the creation and execution of a facilitated interprofessional collaborative process to optimise the integration of the recommended clinical practice for the prevention of type-2 diabetes (T2D) in routine PHC.MethodsThis will be a randomised cluster type II hybrid implementation trial. Nine PHC centres from the Basque Health Service (Osakidetza) will be allocated to two different procedures to engage family doctors and nurses and create an interprofessional collaborative practice to optimise the integration of a T2D primary prevention programme. All centres and PHC professionals will receive training on current guidelines in primary prevention of T2D and effective interventions to promote healthy lifestyles. Headed by a local leader and an external facilitator, centres will conduct a collaborative structured process to model and adapt the intervention and its implementation to the specific context of professionals and centres. One of the groups will apply this strategy globally, promoting the cooperation of all health professionals from the beginning. The other will perform it sequentially, centred first on nurses, who will then seek the pragmatic cooperation of doctors. All patients without diabetes aged ≥ 30 years old who attend collaborating centres at least once during the study period and found to be at high risk of developing T2D will be eligible for programme inclusion. The main outcome measures focus on changes observed in indicators of T2D prevention clinical practice at centre level after 12 and 24 months, associated with the application of one or other engagement procedure. Secondary outcomes will compare their clinical effectiveness in changing eligible exposed patients’ main lifestyle behaviours and risk factors (physical activity and diet, weight, etc.) after 12 months.DiscussionThe PREDIAPS project will generate scientific knowledge on procedures for engaging PHC professional to facilitate feasible and effective adoption of proven interventions for the prevention of T2D in routine clinical practice through the application of implementation strategies.Trial registrationClinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017.

Background: De-implementation or abandonment of ineffective or low-value healthcare is becoming a priority research field globally due to the growing empirical evidence of the high prevalence of such care and its impact in terms of patient safety and social inefficiency. Little is known, however, about the factors, barriers, and facilitators involved or about interventions that are effective in promoting and accelerating the de-implementation of lowvalue healthcare. The De-imFAR study seeks to carry out a structured, evidence-based, and theory-informed process involving the main stakeholders (clinicians, managers, patients, and researchers) for the design, deployment, and assessment of de-implementation strategies for reducing low-value pharmacological prescribing. Methods: A phase I formative study using a systematic and comprehensive framework based on theory and evidence for the design of implementation strategies-specifically, the Behavior Change Wheel (BCW)-will be conducted to design and model de-implementation strategies to favor reductions in low-value pharmacological prescribing of statins in primary prevention of cardiovascular disease (CVD) by main stakeholders (clinicians, managers, patients, and researchers) in a collegiate way. Subsequently, a phase II comparative hybrid trial will be conducted to assess the feasibility and potential effectiveness of at least one active de-implementation strategy to reduce low-value pharmacological prescribing of statins in primary prevention of CVD compared to the usual procedures for dissemination of clinical practice guidelines ("what-not-to-do" recommendations). A mixed-methods evaluation will be used: quantitative for the results of the implementation at the professional level (e.g., adoption, reach and implementation or execution of the recommended clinical practice); and qualitative to determine the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and patients' experiences related to the clinical care received.

Background Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care. Objective We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer. Methods This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures. Results A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service. Conclusions Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden. Trial Registration ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595 International Registered Report Identifier (IRRID) DERR1-10.2196/24835

Background The most efficient procedures to engage and guide healthcare professionals in collaborative processes that seek to optimize practice are unknown. The PREDIAPS project aims to assess the effectiveness and feasibility of different procedures to perform a facilitated interprofessional collaborative process to optimize type 2 diabetes prevention in routine primary care. Methods A type II hybrid cluster randomized implementation trial was conducted in nine primary care centers of the Basque Health Service. All centers received training on effective healthy lifestyle promotion. Headed by a local leader and an external facilitator, centers conducted a collaborative structured process—the PVS-PREDIAPS implementation strategy—to adapt the intervention and its implementation to their specific context. The centers were randomly allocated to one of two groups: one group applied the implementation strategy globally, promoting the cooperation of all health professionals from the beginning, and the other performed it sequentially, centered first on nurses, who later sought the pragmatic cooperation of physicians. The following patients were eligible for inclusion: all those aged ≥ 30 years old with at least one known cardiovascular risk factor and an impaired fasting glucose level (≥ 110-125 mg/dl) but without diabetes who attended centers during the study period. The main outcome measures concerned changes in type 2 diabetes prevention practice indicators after 12 months. Results After 12 months, 3273 eligible patients at risk of type 2 diabetes had attended their family physician at least once, and of these, 490 (15%) have been addressed by assessing their healthy lifestyles in both comparison groups. The proportion of at-risk patients receiving a personalized prescription of lifestyle change was slightly higher (8.6%; range 13.5-5.9% vs 6.8%; range 7.2-5.8%) and 2.3 times more likely (95% CI for adjusted hazard ratio, 1.38-3.94) in the sequential than in the global centers, after 8 months of the intervention program implementation period. The probability of meeting the recommended levels of physical activity and fruit and vegetable intake were four- and threefold higher after the prescription of lifestyle change than only assessment and provision of advice. The procedure of engagement in and execution of the implementation strategy does not modify the effect of prescribing healthy habits (p interaction component of intervention by group, p > 0.05). Discussion Our results show that the PVS-PREDIAPS implementation strategy manages to integrate interventions with proven efficacy in the prevention of type 2 diabetes in clinical practice in primary care. Further, they suggest that implementation outcomes were somewhat better with a sequential facilitated collaborative process focused on enhancing the autonomy and responsibility of nurses who subsequently seek a pragmatic cooperation of GPs. Trial registration Clinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017—retrospectively registered.