Effectiveness of two procedures for deploying a facilitated collaborative modeling implementation strategy—the PVS-PREDIAPS strategy—to optimize type 2 diabetes prevention in primary care: the PREDIAPS cluster randomized hybrid type II implementation trial

Abstract

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.

Conceptual tensions and practical trade-offs in tailoring implementation interventions

“…Judicious use of implementation strategies can enhance the adoption (1), implementation (2), and impact of evidence-based interventions (EBIs) (3). Implementation strategies, "methods or techniques used to enhance the adoption, implementation, and sustainment of a clinical program or practice" (4), are often multifaceted complex interventions, involving combinations of discrete strategies (e.g., audit and feedback, reminders, education/training, etc.).…”

“…To this end, we believe the field needs conceptual grounding on which to build empirical evidence. We propose four interrelated questions about the tailoring process that need to be addressed to advance the understanding and application of tailoring in research and practice: (1) what constitutes tailoring; and when does it begin and end; (2) how is it expected to work; (3) who and what does the tailoring process involve; (4) and, how should tailoring be evaluated?…”

American College of Lifestyle Medicine Expert Consensus Statement: Lifestyle Medicine for Optimal Outcomes in Primary Care

“…Despite multiple studies showing that many LM services can be implemented successfully in primary care settings, 38–41 the expert panel members could not agree on a specific delivery model for implementing LM routinely in everyday primary care settings. This lack of consensus was partly driven by the current lack of high-quality studies available to guide evidence-based implementation.…”

“…Certification through the American Board of Lifestyle Medicine (ABLM) or ACLM is beneficial for clinicians who wish to provide LM services. LM services are optimally delivered through a multidisciplinary team approach 39 and by selecting an appropriate intervention intensity (i.e., dose) for each patient. The intensity of the prescribed intervention can be determined by assessing patient disease severity and factors that affect the patient's ability to implement lifestyle change such as readiness to change, biopsychosocial factors, and social determinants of health, among others.…”