Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials.

INTRODUCTION: Current hospital-based care pathways are generally single-disease centred. As a result, coexisting morbidities are often suboptimally evaluated and managed, a deficiency becoming increasingly apparent among older patients who exhibit heterogeneity in health status, functional abilities, frailty, and other geriatric impairments. To address this issue, our study aims to assess a newly developed patient-centred care pathway for older patients with multimorbidity and cancer. The new care pathway was based on currently available evidence and co-designed by end-users including health care professionals, patients, and informal caregivers. Within this care pathway, all healthcare professionals involved in the care of older patients with multimorbidity and cancer will form a Health Professional Consortium (HPC). The role of the HPC will be to centralise oncologic and non-oncologic treatment recommendations in accordance with the patient's priorities. Moreover, an Advanced Practice Nurse will act as case-manager by being the primary point of contact for the patient, thus improving coordination between specialists, and by organising and leading the consortium. Patient monitoring and the HPC collaboration will be facilitated by digital communication tools designed specifically for this purpose, with the added benefit of being customisable for each patient. MATERIALS AND METHODS: The GERONTE study is a prospective international, multicentric study consisting of two stepped-wedge trials performed at 16 clinical sites across three European countries. Each trial will include 720 patients aged 70 years and over with a new or progressive cancer (breast, lung, colorectal, prostate) and at least one moderate or severe multimorbidity. The patients in the intervention group will receive the new care pathway whereas patients in the control group will receive usual oncologic care. DISCUSSION: GERONTE will evaluate whether this kind of holistic, patient-oriented healthcare management can improve quality of life (primary outcome) and other valuable endpoints in older patients with multimorbidity and cancer. An ancillary study will assess in depth the socio-economic impact of the intervention and deliver concrete implementation guidelines for the GERONTE intervention care pathway. TRIAL REGISTRATION: FRONE: NCT05720910 TWOBE: NCT05423808.

Development of an evidence-based reference framework for care coordination with a focus on the micro level of integrated care: A mixed method design study combining scoping review of reviews and nominal group technique.

BACKGROUND: Because of the limits in conceptualisation of care coordination linked to a large array of care coordination models and definitions available, a care coordination framework is needed with a particular focus on the micro level. OBJECTIVE: To develop an evidence-based reference framework for person-centred care coordination interventions based on international validated definitions. METHODS: This two-step mixed-methods study included first, a scoping review of reviews focus on the impact of care coordination interventions and then, a nominal group technique. The scoping review aimed at identifying the components of the four dimensions of the framework (contexts, activities, actors and tools, and effects). The nominal group technique was to select the relevant components of the dimension 'activities' of the reference framework. RESULTS: The scoping review selected 52 articles from the 1407 retrieved at first. The nominal group selected the 66 most relevant activities from the 159 retrieved in the literature (28 activities of care organisation, 24 activities of care, and 14 activities of facilitation). CONCLUSION: This operational framework focused on care coordination at the micro level, is a useful and innovative tool, applicable in any clinical condition, and in any health care system for describing, implementing and evaluating care coordination programmes.

Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information.

BACKGROUND: Improvement of coordination of all health and social care actors in the patient pathways is an important issue in many countries. Health Information (HI) technology has been considered as a potentially effective answer to this issue. The French Health Ministry first funded the development of five TSN ("Territoire de Soins Numérique"/Digital health territories) projects, aiming at improving healthcare coordination and access to information for healthcare providers, patients and the population, and at improving healthcare professionals work organization. The French Health Ministry then launched a call for grant to fund one research project consisting in evaluating the TSN projects implementation and impact and in developing a model for HI technology evaluation. METHODS: EvaTSN is mainly based on a controlled before-after study design. Data collection covers three periods: before TSN program implementation, during early TSN program implementation and at late TSN program implementation, in the five TSN projects' territories and in five comparison territories. Three populations will be considered: "TSN-targeted people" (healthcare system users and people having characteristics targeted by the TSN projects), "TSN patient users" (people included in TSN experimentations or using particular services) and "TSN professional users" (healthcare professionals involved in TSN projects). Several samples will be made in each population depending on the objective, axis and stage of the study. Four types of data sources are considered: 1) extractions from the French National Heath Insurance Database (SNIIRAM) and the French Autonomy Personalized Allowance database, 2) Ad hoc surveys collecting information on knowledge of TSN projects, TSN program use, ease of use, satisfaction and understanding, TSN pathway experience and appropriateness of hospital admissions, 3) qualitative analyses using semi-directive interviews and focus groups and document analyses and 4) extractions of TSN implementation indicators from TSN program database. DISCUSSION: EvaTSN is a challenging French national project for the production of evidenced-based information on HI technologies impact and on the context and conditions of their effectiveness and efficiency. We will be able to support health care management in order to implement HI technologies. We will also be able to produce an evaluation toolkit for HI technology evaluation. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02837406 , 08/18/2016.