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临床试验/NCT02789800
NCT02789800已完成不适用

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

Université de Sherbrooke4 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2016年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
284
试验地点
4
主要终点
Evaluation of Intervention Effectiveness - Change in Self-Management outcomes

研究概览

简要总结

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

详细描述

A recent systematic review on the prevalence of Multimorbidity (MM) recommended a count of 3+ chronic diseases, with no focus on any single chronic disease in particular. This definition identifies a more vulnerable population with higher needs, lower income or poverty, poorer outcomes and challenging processes of care. It includes people with a wide array of complexity from the uncomplicated course of minimally interacting chronic diseases to the highly complex MM patients. MM is not only important due to the burden on patients, but because it accounts for high utilization. The definition represents a continuum of vulnerability in which there are many opportunities for prevention and management. Despite the high prevalence of MM, most research and health care is still based on a single disease paradigm which may not be appropriate as 45% of primary care patients have MM. A recent Cochrane systematic review on the impact of interventions for patients with MM has identified a paucity of studies internationally with mixed results, thus paving the way for the work of this Team. The most promising intervention, to date, was enhanced teamwork in a multifaceted intervention involving multiple professionals.

Patient-Centred Partnerships between Patients and Providers: The definition of patient-centred partnerships is derived from Canadian policy reports: "collaboration between informed, respected patients and a healthcare team." There is an internationally accepted comprehensive operational definition with four components which will guide many aspects of the proposed research program: first, exploring the patients' diseases and the illness experience; second, understanding the whole person in context; third, finding common ground; and fourth, enhancing the patient-provider relationship. There is empirical evidence for the impact of patient-centred partnerships on better patient outcomes and lower costs. Systematic reviews of interventions indicated promising results for feasible practice-based interventions targeting both providers and patients.

Canadian policy reports defined this second facet of patient-centredness, as "seamless coordination and integration of care." Transitions requiring coordination are a key feature of care for patients with MM. Coordination has been shown to positively impact: symptom relief; social functioning; hospital re-admission and related costs. Papers reviewed by this Team identified the most promising type of intervention to be structured delivery system re-design.

STUDY #2.1 Qualitative Evaluation of the aligned Programs Purpose: The study will: assess how the transformed program performs; distinguish between components of the interventions; and identify contextual factors that may have influenced the content and effectiveness of the intervention. It will also examine the local barriers and facilitators as well as the transitions and coordination of care.

Methods and design: The Team will conduct a qualitative evaluation of the transformed programs to explain how various contexts influence observed effects [1] including the context of the health care systems in each province. A recent example of this research approach in Canada is Best et al, 2012 [2]. Data will be obtained from interviews and written documents. In-depth interviews will be conducted among the four categories of stakeholders. This will include: a) decision-makers (n = 10); b) primary care physicians (n = 10); c) professionals doing the interventions (n = 10); and a d) purposive sample of patients with multimorbidity (n = 10) and their informal caregivers (n=10) [51]. The number of interviews are estimates and will be guided by the saturation of data [3].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 3+ Chronic Conditions
  • 18 to 80 years of age
  • Eligible for DIMAC02 intervention

排除标准

  • Unable to reasonably respond to questionnaires or provide informed consent (ie. cognitive impairment or language barrier)
  • Deemed by provider to be too fragile
  • CAREGIVERS (Study 2.1):
  • Close family member (wife/husband, parent, son/daughter, brother/sister) and/or caregiver to a patient that has received DIMAC02 intervention (first component)
  • Sharing time with the patient (before, during and after the intervention)
  • French speaking
  • DECISION-MAKERS (Study 2.1):
  • FMG Physician-Manager, FMG Coordinators, Decision-Makers/Managers
  • Involved/Familiar with DIMAC02 program
  • DIMAC02 INTERDISCIPLINARY team (Study 2.1):
  • Nurse, Nutritionist, Kinesiologist, Social Worker, Psychologist
  • Has delivered DIMAC02 intervention to at least one patient
  • REFERRAL PROFESSIONALS (Study 2.1):
  • Family physician or nurse/nurse practitioner

结局指标

主要结局

Evaluation of Intervention Effectiveness - Change in Self-Management outcomes

时间窗: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3

Health Education Impact Questionnaire (HeiQ). Score: Reliable improvement

次要结局

  • Evaluation of Intervention Effectiveness - Change in Health Status(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Evaluation of Intervention Effectiveness - Change in Psychological Well-being(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Demographics(T1: Baseline)
  • Evaluation of Intervention Effectiveness - Change in Chronic Diseases(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Evaluation of Intervention Effectiveness - Change in Quality of Life(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Evaluation of Intervention Effectiveness - Equity(T1: Baseline)
  • Evaluation of Intervention Effectiveness - Change in Transitions of Care(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Evaluation of Intervention Effectiveness - Change in Self-Efficacy(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)
  • Evaluation of Intervention Effectiveness - Change in Patient-Centredness(T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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