Patients, caregivers and health-care professionals' experience with an interdisciplinary intervention for people with multimorbidity in primary care: A qualitative study.

BACKGROUND: Multimorbidity challenges the health-care system and requires innovative approaches. In 2015, a 4-month patient-centred interdisciplinary pragmatic intervention was implemented in primary care with the aim of supporting self-management for patients with multimorbidity. OBJECTIVE: To explore the perceptions and experiences of health-care professionals, patients and their caregivers with a 4-month patient-centred interdisciplinary pragmatic intervention in primary care. DESIGN: A descriptive, qualitative study using semi-structured interviews was conducted. SETTING AND PARTICIPANTS: A purposive sample of 30 participants was recruited from seven family medicine groups including patients, caregivers and health-care professionals (HCPs). Interviews were analysed using Thorne's interpretive description approach. RESULTS: Findings were grouped into the benefits and challenges of participating in the intervention. The programme allowed patients to adopt realistic and adapted objectives; to customize interventions to the patient's reality; and to help patients gain confidence, improve their knowledge, skills and motivation to manage their condition. Interprofessional collaboration eased the exchange of information via team meetings and electronic medical records. Challenges were related to collaboration, communication, coordination of work and integration of newly relocated HCPs mainly due to part-time assignments and staff turnover. HCPs part-time schedules limited their availability and hindered patients' follow-up. DISCUSSION AND CONCLUSION: This intervention was useful and rewarding from the HCPs, patients and caregivers' perspective. However, to ensure the success of this complex interdisciplinary intervention, implementers and managers should anticipate organizational barriers such as availability and time management of relocated HCPs.

Real-world crude incidence of hypoglycemia in adults with diabetes: Results of the InHypo-DM Study, Canada.

OBJECTIVE: Very few real-world studies have been conducted to assess the incidence of diabetes-related hypoglycemia. Moreover, there is a paucity of studies that have investigated hypoglycemia among people taking secretagogues as a monotherapy or in combination with insulin. Accordingly, our research team developed and validated the InHypo-DM Person with Diabetes Mellitus Questionnaire (InHypo-DMPQ) with the aim of capturing the real-world incidence of self-reported, symptomatic hypoglycemia. The questionnaire was administered online to a national sample of Canadians (≥18 years old) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) treated with insulin and/or insulin secretagogues. RESEARCH DESIGN AND METHODS: Self-report data obtained from the InHypo-DMPQ were descriptively analyzed to ascertain the crude incidence proportions and annualized incidence densities (rates) of 30-day retrospective non-severe and 1-year retrospective severe hypoglycemia, including daytime and nocturnal events. RESULTS: A total of 552 people (T2DM: 83%; T1DM: 17%) completed the questionnaire. Over half (65.2%) of the total respondents reported experiencing at least one event (non-severe or severe) at an annualized crude incidence density of 35.1 events per person-year. The incidence proportion and rate of non-severe events were higher among people with T1DM versus T2DM (77% and 55.7 events per person-year vs 54% and 28.0 events per person-year). Severe hypoglycemia was reported by 41.8% of all respondents, at an average rate of 2.5 events per person-year. CONCLUSIONS: The results of the InHypo-DMPQ, the largest real-world investigation of hypoglycemia epidemiology in Canada, suggest that the incidence of hypoglycemia among adults with diabetes taking insulin and/or insulin secretagogues is higher than previously thought.

Impact of a primary healthcare quality improvement program on diabetes in Canada: evaluation of the Quality Improvement and Innovation Partnership (QIIP).

OBJECTIVE: Primary healthcare (PHC) quality improvement (QI) initiatives are designed to improve patient care and health outcomes. We evaluated the Quality Improvement and Innovation Partnership (QIIP), an Ontario-wide PHC QI program on access to care, diabetes management and colorectal cancer screening. This manuscript highlights the impact of QIIP on diabetes outcomes and associated vascular risk factors. RESEARCH DESIGN AND METHODS: A cluster matched-control, retrospective prechart and postchart audit was conducted. One physician per QIIP-PHC team (N=34) and control (N=34) were recruited for the audit. Eligible charts were reviewed for prespecified type 2 diabetes mellitus clinical process and outcome data at baseline, during (intervention range: 15-17.5 months) and post. Primary outcome measures were the A1c of patients above study target and proportion of patients with an annual foot exam. Secondary outcome measures included glycemic, hypertension and lipid outcomes and management, screening for diabetes-related complications, healthcare utilization, and diabetes counseling, education and self-management goal setting. RESULTS: More patients in the QIIP group achieved statistically improved lipid testing, eye examinations, peripheral neuropathy exams, and documented body mass index. No statistical differences in A1c, low-density lipoprotein or systolic/diastolic blood pressure values were noted, with no significant differences in medication prescription, specialist referrals, or chart-reported diabetes counseling, education or self-management goals. Patients of QIIP physicians had significantly more PHC visits. CONCLUSION: The QIIP-learning collaborative program evaluation using stratified random selection of participants and the inclusion of a control group makes this one of the most rigorous and promising efforts to date evaluating the impact of a QI program in PHC. The chart audit component of this evaluation highlighted that while QIIP improved some secondary diabetes measures, no improvements in clinical outcomes were noted. This study highlights the importance of formalized evaluation of QI initiatives to provide an evidence base to inform future program planning and scale-up.

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study.

BACKGROUND: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders. METHODS: We will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.