Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.
ABSTRACT: Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes.All 933,789 people aged ?40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p?=?0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p?=?0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population.The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.
Project description:BACKGROUND:Many patients with or at risk for chronic kidney disease (CKD) in the primary care setting are not receiving recommended care. OBJECTIVE:The objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting. DESIGN:A pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted. SETTING:The study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group. INTERVENTION:The intervention group will receive resources from the "CKD toolkit" to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support. MEASUREMENTS:Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of physicians in the intervention group to understand why the intervention achieved the observed effects. CONCLUSIONS:If our intervention improves care, then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02274298.
Project description:The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (CDA) created an implementation strategy to improve the implementation of its 2008 guidelines. This study will evaluate the impact of the strategy to improve cardiovascular disease (CVD) screening, prevention and treatment for people with diabetes.A pragmatic cluster-randomized trial will be conducted to evaluate the CDA's CVD Toolkit. All family physicians in Ontario, Canada were randomly allocated to receive the Toolkit, which includes several printed educational materials targeting CVD screening, prevention and treatment, either in spring 2009 (intervention arm) or in spring 2010 (control arm). Randomization occurred at the level of the practice. Forty family physicians from each arm will be recruited to participate, and the medical records for 20 of their diabetic patients at high risk for CVD will be retrospectively reviewed. Outcome measures will be assessed for each patient between July 2009 and March 2010. The primary outcome will be that the patient is receiving a statin. Secondary outcomes will include 1) the receipt of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, 2) various intermediate measures (A1c, blood pressure, LDL-cholesterol, total-/HDL-cholesterol ratio, body mass index and waist circumference), and 3) clinical inertia (the failure to change therapy in response to an abnormal A1c, blood pressure or cholesterol reading). The analysis will be carried out using multilevel hierarchical logistic regression models to account for the clustered nature of the data. The group assignment will be a physician-level variable. In addition, a process evaluation study with six focus groups of family physicians will assess the acceptability of the CDA's Toolkit and will explore factors contributing to any change or lack of change in behaviour, from the perspectives of family physicians.Printed educational materials for physicians have been shown to exert small-to-moderate changes in patient care. The CDA's CVD Toolkit is an example of a practice guideline implementation strategy that can be disseminated to a wide audience relatively inexpensively, and so demonstrating its effectiveness at improving diabetes care could have important consequences for guideline developers, policy makers and clinicians.
Project description:BACKGROUND:The primary aim of this study was to compare the efficacy of three physical activity (PA) behavioural intervention strategies in a sample of adults with type 2 diabetes. METHOD/DESIGN:Participants (N = 287) were randomly assigned to one of three groups consisting of the following intervention strategies: (1) standard printed PA educational materials provided by the Canadian Diabetes Association [i.e., Group 1/control group)]; (2) standard printed PA educational materials as in Group 1, pedometers, a log book and printed PA information matched to individuals' PA stage of readiness provided every 3 months (i.e., Group 2); and (3) PA telephone counseling protocol matched to PA stage of readiness and tailored to personal characteristics, in addition to the materials provided in Groups 1 and 2 (i.e., Group 3). PA behaviour measured by the Godin Leisure Time Exercise Questionnaire and related social-cognitive measures were assessed at baseline, 3, 6, 9, 12 and 18-months (i.e., 6-month follow-up). Clinical (biomarkers) and health-related quality of life assessments were conducted at baseline, 12-months, and 18-months. Linear Mixed Model (LMM) analyses will be used to examine time-dependent changes from baseline across study time points for Groups 2 and 3 relative to Group 1. DISCUSSION:ADAPT will determine whether tailored but low-cost interventions can lead to sustainable increases in PA behaviours. The results may have implications for practitioners in designing and implementing theory-based physical activity promotion programs for this population. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov identifier: NCT00221234.
Project description:There is growing evidence that patient navigation improves breast cancer screening rates; however, there are limited efficacy studies of its effect among African American older adult women.To evaluate the effect of patient navigation on screening mammography among African American female Medicare beneficiaries in Baltimore, MD.The Cancer Prevention and Treatment Demonstration (CPTD), a multi-site study, was a randomized controlled trial conducted from April 2006 through December 2010.Community-based and clinical setting.The CPTD Screening Trial enrolled 1905 community-dwelling African American female Medicare beneficiaries who were ?65 years of age and resided in Baltimore, MD. Participants were recruited from health clinics, community centers, health fairs, mailings using Medicare rosters, and phone calls.Participants were randomized to either: printed educational materials on cancer screening (control group) or printed educational materials + patient navigation services designed to help participants overcome barriers to cancer screening (intervention group).Self-reported receipt of mammography screening within 2 years of the end of the study.The median follow-up period for participants in this analysis was 17.8 months. In weighted multivariable logistic regression analyses, women in the intervention group had significantly higher odds of being up to date on mammography screening at the end of the follow-up period compared to women in the control group (odds ratio [OR] 2.26, 95 % confidence interval [CI]1.59-3.22). The effect of the intervention was stronger among women who were not up to date with mammography screening at enrollment (OR 3.63, 95 % CI 2.09-6.38).Patient navigation among urban African American Medicare beneficiaries increased self-reported mammography utilization. The results suggest that patient navigation for mammography screening should focus on women who are not up to date on their screening.
Project description:The death certificate is an important medical document that impacts mortality statistics and health care policy. Resident physician accuracy in completing death certificates is poor. We assessed the impact of two educational interventions on the quality of death certificate completion by resident physicians. Two-hundred and nineteen internal medicine residents were asked to complete a cause of death statement using a sample case of in-hospital death. Participants were randomized into one of two educational interventions: either an interactive workshop (group I) or provided with printed instruction material (group II). A total of 200 residents completed the study, with 100 in each group. At baseline, competency in death certificate completion was poor. Only 19% of residents achieved an optimal test score. Sixty percent erroneously identified a cardiac cause of death. The death certificate score improved significantly in both group I (14+/-6 vs 24+/-5, p<0.001) and group II (14+/-5 vs 19+/-5, p<0.001) postintervention from baseline. Group I had a higher degree of improvement than group II (24+/-5 vs 19+/-5, p<0.001). Resident physicians' skills in death certificate completion can be improved with an educational intervention. An interactive workshop is a more effective intervention than a printed handout.
Project description:Evidence on the effectiveness of printed educational messages in contributing to increasing evidence-based clinical practice is contradictory. Nonetheless, these messages flood physician offices, in an attempt to promote treatments that can reduce costs while improving patient outcomes. This study evaluated the ability of printed educational messages to promote the choice of thiazides as the first-line treatment for individuals newly diagnosed with hypertension, a practice supported by good evidence and included in guidelines, and one which could reduce costs to the health care system.The study uses a pragmatic, cluster randomized controlled trial (randomized by physician practice group).The setting involves all Ontario general/family practice physicians. Messages advising the use of thiazides as the first-line treatment of hypertension were mailed to each physician in conjunction with a widely read professional newsletter. Physicians were randomized to receive differing versions of printed educational messages: an "insert" (two-page evidence-based article) and/or one of two different versions of an "outsert" (short, directive message stapled to the outside of the newsletter). One outsert was developed without an explicit theory and one with messages developed targeting factors from the theory of planned behaviour or neither (newsletter only, with no mention of thiazides). The percentage of patients aged over 65 and newly diagnosed with hypertension who were prescribed a thiazide as the sole initial prescription medication. The effect of the intervention was estimated using a logistic regression model estimated using generalized estimating equation methods to account for the clustering of patients within physician practices.Four thousand five hundred four physicians (with 23,508 patients) were randomized, providing 97 % power to detect a 5 % absolute increase in prescription of thiazides. No intervention effect was detected. Thiazides were prescribed to 27.6 % of the patients who saw control physicians, 27.4 % for the insert, 26.8 % for the outsert and 28.3 % of the patients who saw insert + outsert physicians, p = 0.54.The study conclusively failed to demonstrate any impact of the printed educational messages on increasing prescribing of thiazide diuretics for first-line management of hypertension.ISRCTN72772651.
Project description:Carriers of breast cancer gene (BRCA) mutations are asked to communicate genetic test results to their biological relatives to increase awareness of cancer risk and promote use of genetic services. This process is highly variable from family to family. Interventions that support communication of genetic test results, coping, and offer decision support in families harboring a pathogenic variant may contribute to effective management of hereditary cancer.The aim of this paper was to describe the development of the Family Gene Toolkit, a Web-based intervention targeting BRCA carriers and untested blood relatives, designed to enhance coping, family communication, and decision making.We present findings from focus groups regarding intervention acceptability and participant satisfaction and from a pre-post pilot study with random allocation to a wait-listed control group regarding intervention feasibility and usability.The Family Gene Toolkit was developed by a multidisciplinary team as a psycho-educational and skills-building intervention. It includes two live webinar sessions and a follow-up phone call guided by a certified genetic counselor and a master's prepared oncology nurse. Each live webinar includes two modules (total four modules) presenting information about BRCA mutations, a decision aid for genetic testing, and two skill-building modules for effective coping and family communication. Participants in focus groups (n=11) were highly satisfied with the intervention, reporting it to be useful and describing clearly the important issues. From the 12 dyads recruited in the pre-post pilot study (response rate 12/52, 23%), completion rate was 71% (10/14) for intervention and 40% (4/10) for wait-listed control groups.Acceptability and satisfaction with the Family Gene Toolkit is high. On the basis of the findings from usability and feasibility testing, modifications on timing, delivery mode, and recruitment methods have been implemented.ClinicalTrials.gov NCT02154633; https://clinicaltrials.gov/ct2/show/NCT02154633 (Archived by WebCite at http://www.webcitation.org/6yYNvLPjv).
Project description:To develop easily disseminated educational materials that enable early detection of skin cancer, and to examine the effectiveness of the materials to promote skin self-examination (SSE) among kidney transplant recipients (KTRs).Randomized controlled trial of an educational intervention in comparison with a group that received only the assessment, education, and treatment as part of usual care with a nephrologist.Academic ambulatory nephrology practice.Seventy-five KTRs returning for routine care to their nephrologists 1 to 1.2 years or 3 to 7 years after transplantation.Educational workbook.Skin self-examination performance and new appointments with a dermatologist if a concerning skin lesion was found.Twenty-two percent of those in the control group checked their skin after the visit compared with 89% of the treatment condition; thus, KTRs receiving the intervention were significantly more likely to have checked their skin (?(2); P < .001). Among the 8 control KTRs who checked their skin, none found areas of concern. Of the 34 intervention KTRs who checked their skin, 12 participants (35%) found areas of concern. All 12 of these individuals made appointments with a dermatologist for follow-up.The KTRs were receptive to performing SSE and acted on the recommendation made in the workbook to make an appointment with a dermatologist when a concerning lesion was discovered. Printed educational materials can be initiated in the tertiary care center 1 year after transplantation and used across a continuum of time during which KTRs may be transferred from the tertiary care center to community nephrologists.clinicaltrials.gov Identifier: NCT01127737.
Project description:BACKGROUND: Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers. AIMS: This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs' (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial). METHODS: The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs' detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In addition to receipt of the printed guideline, practitioners in the intervention group will be invited to participate in an interactive, opinion leader-led, educational face-to-face workshop. The theory-informed intervention aims to address identified barriers to and enablers of implementation of recommendations. Researchers responsible for identifying the cohort of patients with suspected cognitive impairment, and their detection and diagnosis outcomes, will be blind to group allocation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12611001032943 (date registered 28 September, 2011).
Project description:BACKGROUND:Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany. METHODS/DESIGN:The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents' quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed. CONCLUSIONS:We expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02341898.