Holistic needs assessment in outpatient cancer care: a randomised controlled trial.

DESIGN: Analyst blinded, parallel, multi-centre, randomised controlled trial (RCT). PARTICIPANTS: People with confirmed diagnoses of cancer (head and neck, skin or colorectal) attending follow-up consultation 3 months post-treatment between 2015 and 2020. INTERVENTION: Holistic needs assessment (HNA) or care as usual during consultation. OBJECTIVE: To establish whether incorporating HNA into consultations would increase patient participation, shared decision making and postconsultation self-efficacy. OUTCOME MEASURES: Patient participation in the consultations examined was measured using (a) dialogue ratio (DR) and (b) the proportion of consultation initiated by patient. Shared decision making was measured with CollaboRATE and self-efficacy with Lorig Scale. Consultations were audio recorded and timed. RANDOMISATION: Block randomisation. BLINDING: Audio recording analyst was blinded to study group. RESULTS: 147 patients were randomised: 74 control versus 73 intervention. OUTCOME: No statistically significant differences were found between groups for DR, patient initiative, self-efficacy or shared decision making. Consultations were on average 1 min 46 s longer in the HNA group (respectively, 17 m 25 s vs 15 min 39 s). CONCLUSION: HNA did not change the amount of conversation initiated by the patient or the level of dialogue within the consultation. HNA did not change patient sense of collaboration or feelings of self-efficacy afterwards. HNA group raised more concerns and proportionally more emotional concerns, although their consultations took longer than treatment as usual. IMPLICATIONS FOR PRACTICE: This is the first RCT to test HNA in medically led outpatient settings. Results showed no difference in the way the consultations were structured or received. There is wider evidence to support the roll out of HNA as part of a proactive, multidisciplinary process, but this study did not support medical colleagues facilitating it. TRIAL REGISTRATION NUMBER: NCT02274701.

Structuring and organizing interprofessional healthcare in partnership with patients with diabetes: the INterprofessional Management and Education in Diabetes care (INMED) pathway.

Type 2 diabetes is a complex chronic disease that requires ongoing monitoring by an interprofessional team to prevent complications. The INMED (INterprofessional Management and Education in Diabetes) care pathway was developed by our team to optimize primary care services for these patients and their families. The objective of this study is to describe the preliminary results of its adoption and implementation. The INMED care pathway is organized into four axes: (a) continuing professional education, (b) self-management support, (c) case management, and (d) ongoing evaluation of the quality of diabetes care and services. A multiple-case study is underway to document its effects on practice change using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Preliminary results on the adoption and implementation revealed some strengths: (a) regular patient follow-up by the case manager, (b) scheduling of physician appointments when required, and (c) regular screening for risk factors. Barriers were also identified: (a) lack of clear understanding of the case manager role, (b) lack of referrals to team members, and (c) lack of use of the motivational interview approach. The INMED care pathway is being adopted by primary care teams but challenges need to be overcome to improve its reach and effectiveness.

Evaluation of the implementation and associated effects of advanced access in university family medicine groups: a study protocol.

BACKGROUND: Timely access in primary health care is one of the key issues facing health systems. Among many interventions developed around the world, advanced access is the most highly recommended intervention designed specifically to improve timely access in primary care settings. Based on greater accessibility linked with patients' relational continuity and informational continuity with a primary care professional or team, this organizational model aims to ensure that patients obtain access to healthcare services at a time and date convenient for them when needed regardless of urgency of demand. Its implementation requires a major organizational change based on reorganizing the practices of all the administrative staff and health professionals. In recent years, advanced access has largely been implemented in primary care organizations. However, despite its wide dissemination, we observe considerable variation in the implementation of the five guiding principles of this model across organizations, as well as among professionals working within the same organization. The main objective of this study is to assess the variation in the implementation of the five guiding principles of advanced access in teaching primary healthcare clinics across Quebec and to better understand the influence of the contextual factors on this variation and on outcomes. METHODS: This study will be based on an explanatory sequential design that includes 1) a quantitative survey conducted in 47 teaching primary healthcare clinics, and 2) a multiple case study using mixed data, contrasted cases (n = 4), representing various implementation profiles and geographical contexts. For each case, semi-structured interviews and focus group will be conducted with professionals and patients. Impact analyses will also be conducted in the four selected clinics using data retrieved from the electronic medical records. DISCUSSION: This study is important in social and political context marked by accessibility issues to primary care services. This research is highly relevant in a context of massive media coverage on timely access to primary healthcare and a large-scale implementation of advanced access across Quebec. This study will likely generate useful lessons and support evidence-based practices to refine and adapt the advanced access model to ensure successful implementation in various clinical contexts facing different challenges.

Design and rationale for a pragmatic cluster randomized trial of the Cardiovascular Health Awareness Program (CHAP) for social housing residents in Ontario and Quebec, Canada.

BACKGROUND: The Cardiovascular Health Awareness Program (CHAP) uses volunteers to provide cardiovascular disease (CVD) and diabetes screening in a community setting, referrals to primary care providers, and locally available programs targeting lifestyle modification. CHAP has been adapted to target older adults residing in social housing, a vulnerable segment of the population. Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes. The study objective is to evaluate whether there is a reduction in unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors' housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program. METHODS/DESIGN: This is a pragmatic, cluster randomized controlled trial in community-based social (subsidized) housing buildings in Ontario and Quebec. All residents of 14 matched pairs (intervention/control) of apartment buildings will be included. Buildings with 50-200 apartment units with the majority of residents aged 55+ and a unique postal code are included. All individuals residing within the buildings at the start of the intervention period are included (intention to treat, open cohort). The intervention instrument consists of CHAP screens for high blood pressure using automated blood pressure monitors and for diabetes using the Canadian Diabetes Risk (CANRISK) assessment tool. Monthly drop-in sessions for screening/monitoring are held within a common area of the building. Group health education sessions are also held monthly. Reports are sent to family doctors, and attendees are encouraged to visit their family doctor. The primary outcome measure is monthly CVD-related ED visits and hospitalizations over a 1-year period post randomization. Secondary outcomes are all ED visits, hospitalizations, quality of life, cost-effectiveness, and participant experience. DISCUSSION: It is anticipated that CVD-related ED visits and hospitalizations will decrease in the intervention buildings. Using the volunteer-led CHAP program, there is significant opportunity to improve the health of older adults in social housing. TRIAL REGISTRATION: ClinicalTrials.gov,NCT03549845. Registered on 15 May 2018. Updated on 21 May 2019.

Drug samples in family medicine teaching units: a cross-sectional descriptive study: Part 1: drug sample management policies and the relationship between the pharmaceutical industry and residents in Quebec.

OBJECTIVE: To determine the existence and the level of health care professional (HCP) knowledge of local policies regarding drug sample use and the relationship between residents and the pharmaceutical industry in academic primary health care settings. DESIGN: Descriptive cross-sectional survey. Health care providers were invited to complete a self-administered questionnaire on drug sample use between February and December 2013. Managers of drug samples were also asked to complete a specific questionnaire on drug sample management and policies and an inventory log sheet. Data about the existence of written policies were validated with health and social services centre (HSCC) directors or pharmacy departments and family medicine teaching unit (FMTU) directors between February and June 2014. SETTING: All 42 FMTUs in Quebec. PARTICIPANTS: All HCPs in the FMTUs authorized to hand out drug samples (practising physicians, residents, pharmacists, and nurses). Dispensers were defined as those who reported using drug samples. Managers were defined as HCPs or staff members who managed drug samples. MAIN OUTCOME MEASURES: Existence of written policies on drug sample use in HSCCs and FMTUs; whether FMTUs applied the HSCC policies if they existed; whether dispensers were aware of the existence of the policies; and whether policies on the relationships between residents and pharmaceutical companies existed. RESULTS: Among the 42 FMTUs, 33 (79%) kept drug samples. Of these, 30% (10 of 33) did not have policies about drug samples in the FMTU or in the HSCC. A total of 67% (579 of 859) of HCPs from these FMTUs reported using drug samples. Most dispensers did not know if a policy existed in their FMTU (n = 297; 51%) or their HSCC (n = 420; 73%). Eleven (26%) of the 42 FMTU directors reported having a policy regarding relationships between residents and the pharmaceutical industry. Most drug sample dispensers were not aware whether such a policy existed (n = 310; 54%). CONCLUSION: Many FMTUs did not have policies regarding drug samples or relationships between residents and the pharmaceutical industry. Variation in use and management of drug samples and the lack of knowledge of HCPs about the existence of policies point to the need to implement uniform policies in all FMTUs in Quebec.

Drug samples in family medicine teaching units: a cross-sectional descriptive study: Part 2: portrait of drug sample management in Quebec.

OBJECTIVE: To draw a portrait of drug sample management in academic primary health care settings and assess conformity to existing Canadian guidelines. DESIGN: Descriptive cross-sectional survey. SETTING: All 33 family medicine teaching units (FMTUs) in Quebec that kept drug samples. PARTICIPANTS: Health care professionals or FMTU staff who managed drug samples (ie, managers). MAIN OUTCOME MEASURES: Drug sample managers completed a self-administered questionnaire between February and December 2013. Questionnaires inquired about sample selection, procurement, reception, storage, inventory, and disposal. Results were compared with the Canada's Research-Based Pharmaceutical Companies Code of Ethical Practices (2012) and the Canadian Medical Association Guidelines for Physicians in Interactions with Industry (2007). RESULTS: All 33 FMTUs responded to the questionnaire. According to managers, no FMTUs had written selection criteria to guide sample choice. Almost one-third (30%) of FMTUs had uncontrolled access to drug sample cabinets. Even though pharmaceutical companies must distribute drug samples to authorized professionals only, these professionals were involved in the procurement and the reception of samples in 79% and 56% of FMTUs, respectively. Only 15% of FMTUs kept track of samples distributed, 82% checked expiration dates, and 85% ensured proper disposal as recommended. CONCLUSION: The management of drug samples in the FMTUs in Quebec is heterogeneous, with many FMTUs and pharmaceutical companies not following Canadian guidelines.

Drug samples in family medicine teaching units: a cross-sectional descriptive study: Part 3: availability and use of drug samples in Quebec.

OBJECTIVE: To draw a portrait of drug sample distribution and to assess the concordance between drug samples distributed and the medical problems encountered in the ambulatory primary health care setting. DESIGN: Descriptive cross-sectional survey. A self-administered questionnaire was distributed to all health care professionals (HCPs) in family medicine teaching units (FMTUs) that kept drug samples between February and December 2013. Dispensers were defined as HCPs reporting the use of drug samples. Concurrently, an inventory log sheet was completed by managers of drug samples to document the contents of sample cabinets. Data from the Canadian Disease and Therapeutic Index were used as the criterion standard to assess the consistency between the drug samples found in the cabinets and the profile of the most frequent health problems encountered in primary care. SETTING: All 33 FMTUs that kept drug samples in Quebec. PARTICIPANTS: Health care professionals authorized to hand out drug samples (practising physicians, residents, pharmacists, and nurses), and managers of drug sample cabinets. MAIN OUTCOME MEASURES: Dispensing practices of HCPs; number of doses of each drug contained in the sample cabinets; total market value of the samples; concordance between the drug sample categories made available and the most common medical problems encountered in primary care; and data on safe handling, ethical issues, effect of the pharmaceutical industry on prescribing behaviour, and inventory of samples. RESULTS: Among 859 HCPs, 579 (67%) reported dispensing drug samples. A large proportion of dispensers (88%) were unable to find the specific drug they sought and half of them (51%) provided the patients with a drug sample even if it was not their first choice for treatment. The drug sample cabinet inventory revealed products from 292 different companies and identified a total of 382 363 medication doses for a total value of $201 872. We found gaps among types of drugs provided to patients, those the HCPs would consider useful, and those available in the cabinets. CONCLUSION: Drug samples available in FMTUs do not meet the needs of many patients and HCPs, suggesting that the main driving force for drug sample distribution is not patient care. Policies on drug samples in FMTUs should be uniform across the province, and management should be as strict as in community pharmacies. Otherwise, prohibiting their use should be considered.

Decisional needs assessment of patients with complex care needs in primary care: a participatory systematic mixed studies review protocol.

INTRODUCTION: Patients with complex care needs (PCCNs) often suffer from combinations of multiple chronic conditions, mental health problems, drug interactions and social vulnerability, which can lead to healthcare services overuse, underuse or misuse. Typically, PCCNs face interactional issues and unmet decisional needs regarding possible options in a cascade of interrelated decisions involving different stakeholders (themselves, their families, their caregivers, their healthcare practitioners). Gaps in knowledge, values clarification and social support in situations where options need to be deliberated hamper effective decision support interventions. This review aims to (1) assess decisional needs of PCCNs from the perspective of stakeholders, (2) build a taxonomy of these decisional needs and (3) prioritise decisional needs with knowledge users (clinicians, patients and managers). METHODS AND ANALYSIS: This review will be based on the interprofessional shared decision making (IP-SDM) model and the Ottawa Decision Support Framework. Applying a participatory research approach, we will identify potentially relevant studies through a comprehensive literature search; select relevant ones using eligibility criteria inspired from our previous scoping review on PCCNs; appraise quality using the Mixed Methods Appraisal Tool; conduct a three-step synthesis (sequential exploratory mixed methods design) to build taxonomy of key decisional needs; and integrate these results with those of a parallel PCCNs' qualitative decisional need assessment (semistructured interviews and focus group with stakeholders). ETHICS AND DISSEMINATION: This systematic review, together with the qualitative study (approved by the Centre Intégré Universitaire de Santé et Service Sociaux du Saguenay-Lac-Saint-Jean ethical committee), will produce a working taxonomy of key decisional needs (ontological contribution), to inform the subsequent user-centred design of a support tool for addressing PCCNs' decisional needs (practical contribution). We will adapt the IP-SDM model, normally dealing with a single decision, for PCCNs who experience cascade of decisions involving different stakeholders (theoretical contribution). Knowledge users will facilitate dissemination of the results in the Canadian primary care network. PROSPERO REGISTRATION NUMBER: CRD42015020558.

Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

INTRODUCTION: People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. METHODS AND ANALYSIS: The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. ETHICS AND DISSEMINATION: This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. TRAIL REGISTRATION NUMBER: Clinical Trials.gov NCT02274701.

A cluster randomized controlled Trial to Evaluate an Ambulatory primary care Management program for patients with dyslipidemia: the TEAM study.

BACKGROUND: Few studies have reported the efficacy of collaborative care involving family physicians and community pharmacists for patients with dyslipidemia. METHODS: We randomly assigned clusters consisting of at least two physicians and at least four pharmacists to provide collaborative care or usual care. Under the collaborative care model, pharmacists counselled patients about their medications, requested laboratory tests, monitored the effectiveness and safety of medications and patients' adherence to therapy, and adjusted medication dosages. After 12 months of follow-up, we assessed changes in low-density lipoprotein (LDL) cholesterol (the primary outcome), the proportion of patients reaching their target lipid levels and changes in other risk factors. RESULTS: Fifteen clusters representing a total of 77 physicians and 108 pharmacists were initially recruited, and a total of 51 physicians and 49 pharmacists were included in the final analyses. The collaborative care teams followed a total of 108 patients, and the usual care teams followed a total of 117 patients. At baseline, mean LDL cholesterol level was higher in the collaborative care group (3.5 v. 3.2 mmol/L, p = 0.05). During the study, patients in the collaborative care group were less likely to receive high-potency statins (11% v. 40%), had more visits with health care professionals and more laboratory tests, were more likely to have their lipid-lowering treatment changed and were more likely to report lifestyle changes. At 12 months, the crude incremental mean reduction in LDL cholesterol in the collaborative care group was -0.2 mmol/L (95% confidence interval [CI] -0.3 to -0.1), and the adjusted reduction was -0.05 (95% CI -0.3 to 0.2). The crude relative risk of achieving lipid targets for patients in the collaborative care group was 1.10 (95% CI 0.95 to 1.26), and the adjusted relative risk was 1.16 (95% CI 1.01 to 1.34). INTERPRETATION: Collaborative care involving physicians and pharmacists had no significant clinical impact on lipid control in patients with dyslipidemia. International Standard Randomized Controlled Trial register no. ISRCTN66345533.

The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care.

BACKGROUND: Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects. Effective programs to address this problem are lacking. We hypothesized that an information technology-supported management program could help improve blood pressure (BP) control. METHODS AND RESULTS: This randomized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP >130/80 and daytime BP >135/85 mm Hg measured with ambulatory monitoring (ABPM). Intervention subjects received a BP monitor and access to an information technology-supported adherence and BP monitoring system providing nurses, pharmacists, and physicians with monthly reports. Control subjects received usual care. The mean (+/-SD) follow-up was 348 (+/-78) and 349 (+/-84) days in the intervention and control group, respectively. The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic (-11.9 versus -7.1 mm Hg; P<0.001) and diastolic BP (-6.6 versus -4.5 mm Hg; P=0.007). The proportion of subjects that achieved Canadian Guideline target BP (46.0% versus 28.6%) was also greater in the intervention group (P=0.006). We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control. The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents (P=0.03), more antihypertensive classes at study end (P=0.007), and a trend toward improved adherence measured by prescription refills (P=0.07). CONCLUSIONS: This multidisciplinary information technology-supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting.

MEDICODE: an instrument to describe and evaluate exchanges on medications that occur during medical encounters.

OBJECTIVE: To examine the psychometric properties of MEDICODE, a coding instrument developed to assess medication discussions during medical consultations. METHODS: Inter-coder reliability, test-retest stability, and concurrent validity with the Roter Interaction Analysis System (RIAS) and predictive validity with the Medical Interview Satisfaction Scale (MISS) were calculated. RESULTS: Inter-coder reliability and test-retest stability for medication class and status were both very good. Inter-coder agreement and test-retest stability for theme identification were mostly over 90%. Kappa values for theme identification varied from acceptable to excellent for 21 of the 29 and for 26 of the 37 Kappa coefficients that could be calculated. The mean percent agreement between MEDICODE and RIAS for medication class was of 96.8% and the mean Kappa value was 0.83. Although the mean percent agreement for the presence of a theme in MEDICODE and RIAS was 81%, the average Kappa coefficients were lower at 0.40. However, each of the four broad theme categories had its share of themes with robust Kappa values. We found significant positive correlations (p<0.05) between discussions of medication main effects and instructions with patient satisfaction. CONCLUSION: With a reasonable amount of training, the coders were able to produce reliable and valid measures of discussions of medications during medical consultations. PRACTICAL IMPLICATIONS: MEDICODE will facilitate the study of the impact of the nature and intensity of discussions about medications during consultations on patient medication knowledge, medication recall and compliance.

Intercultural communication competence in family medicine: lessons from the field.

OBJECTIVE: To describe the challenges for immigrant patients and their physicians and their skills in intercultural communication (ICC). METHODS: We videotaped one clinical encounter for each of 24 psychologically distressed patients visiting their regular family physician. The physician and the patient, each separately, viewed the videotape of their clinical encounter and commented on important moments identified by the participant or the researchers. RESULTS: Patients and/or physicians lacked knowledge of the effects of culture on the doctor-patient relationship and expressions of distress as well as the effects of immigrant-specific stress on health. Most subjects were motivated to have an interpersonal, rather than an intercultural encounter. Physicians and patients demonstrated the skills needed to achieve an interpersonal encounter. Some physicians and their patients achieved intercultural meetings as a result of their interpersonal interactions over a period of years. DISCUSSION: Lack of formal training partly explains why most participants demonstrated an elementary level of ICC. In addition, Identity Management Theory and Co-cultural Theory explain some of the barriers to ICC. PRACTICE IMPLICATIONS: Providing physicians with formal training in intercultural communication and empowerment training for patients is likely to improve the quality of care of immigrants.