Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial.

BACKGROUND: MyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams. OBJECTIVE: Assess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics. METHODS: We conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups. RESULTS: One thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors. CONCLUSION: An interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial.

BACKGROUND: Person-centered care is critical for delivering high-quality diabetes care. Shared decision making (SDM) is central to person-centered care, and in diabetes care, it can improve decision quality, patient knowledge, and patient risk perception. Delivery of person-centered care can be facilitated with the use of patient decision aids (PtDAs). We developed MyDiabetesPlan, an interactive SDM and goal-setting PtDA designed to help individualize care priorities and support an interprofessional approach to SDM. OBJECTIVE: This study aims to assess the impact of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level. METHODS: A two-step, parallel, 10-site cluster randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later) was conducted. Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario. FHTs were randomly assigned to MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm. MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) followed by patients (second step) were trained on its use. Control participants received static generic Diabetes Canada resources. Patients were not blinded. Participants completed validated questionnaires at baseline, 6 months, and 12 months. The primary outcome at the individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM. Multilevel hierarchical regression models were used. RESULTS: At the end of the study, the intervention group (5 clusters, n=111) had a modest reduction in total decisional conflicts compared with the control group (5 clusters, n=102; -3.5, 95% CI -7.4 to 0.42). Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0). CONCLUSIONS: Use of goal-setting decision aids modestly improved decision quality and chronic illness care but not quality of life. Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral support. The next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT02379078; https://clinicaltrials.gov/ct2/show/NCT02379078.

Readmission rates following heart failure: a scoping review of sex and gender based considerations.

BACKGROUND: Although hospital readmission for heart failure (HF) is an issue for both men and women, little is known about differences in readmission rates by sex. Consequently, strategies to optimize readmission reduction programs and care strategies for women and men remain unclear. Our study aims were: (1) to identify studies examining readmission rates according to sex, and (2) to provide a qualitative overview of possible considerations for the impact of sex or gender. METHODS: We conducted a scoping review using the Arksey and O'Malley framework to include full text articles published between 2002 and 2017 drawn from multiple databases (MEDLINE, EMBASE), grey literature (i.e. National Technical information, Duck Duck Go), and expert consultation. Eligible articles included an index heart failure episode, readmission rates, and sex/gender-based analysis. RESULTS: The search generated 5887 articles, of which 746 underwent full abstract text consideration for eligibility. Of 164 eligible articles, 34 studies addressed the primary outcome, 103 studies considered sex differences as a secondary outcome and 25 studies stratified data for sex. Good inter-rater agreement was reached: 83% title/abstract; 88% full text; kappa: 0.69 (95%CI: 0.53-0.85). Twelve of 34 studies reported higher heart failure readmission rates for men and six studies reported higher heart failure readmission rates for women. Using non composite endpoints, five studies reported higher HF readmission rates for men compared to three studies reporting higher HF readmission rates for women. Overall, there was heterogeneity between studies when examined by sex, but one observation emerged that was related to the timing of readmissions. Readmission rates for men were higher when follow-up duration was longer than 1 year. Women were more likely to experience higher readmission rates than men when time to event was less than 1 year. CONCLUSIONS: Future studies should consider different time horizons in their designs and avoid the use of composite measures, such as readmission rates combined with mortality, which are highly skewed by sex. Co-interventions and targeted post-discharge approaches with attention to sex would be of benefit to the HF patient population.

Developing Registries and Effective Care Models for the Management of Hip Fractures: Aligning Political, Organizational Drivers with Clinical Outcomes.

PURPOSE OF REVIEW: The aim of the review is to conduct a literature search on cost-effectiveness or cost savings of osteoporosis fracture liaison services. RECENT FINDINGS: We identified four types of FLS. A total of 11 cost-effectiveness studies examining 15 models of secondary fracture prevention models were identified. Nine models were found to be cost-saving, and five were found to be cost-effective. It is possible to adopt a cost-effective model for fracture liaison services and expand across geographical regions. Adopting registries can have the added benefit of monitoring quality improvement practices and treatment outcomes. Challenges exist in implementing registries where centralized data collections across different chronic conditions are politically driving agendas. In order to align political and organizational strategic plans, a core set of outcome evaluations that are both focused on patient and provider experience in addition to treatment outcomes can be a step toward achieving better health and services.

Co-morbidities in elderly patients with hip fracture: recommendations of the ISFR-IOF hip fracture outcomes working group.

INTRODUCTION: Hip fractures are the second leading cause of hospitalization in the aged and by 2041, epidemiologists forecast an increase in economic cost to $2.4 billion. The hip patient population often presents with comorbidities causing these patients to receive less aggressive medical treatment and have a low quality of life. We believe that physical function is a patient-important outcome for many medical and surgical interventions. The functional co-morbidity index (FCI), unlike prior co-morbidity indices, was developed with physical function as an outcome instead of being designed for administrative purposes or to predict mortality. Our objective was to evaluate the perceptions of practitioners in hip fracture care about the impact of comorbidities on physical function as primary outcome. METHODS: We piloted and then distributed a self-administered survey to members of the International Society for Fracture Repair hip fracture outcomes working group. For each of the 18 diagnoses included in the FCI index, we asked in our survey whether the presence of the co-morbidity and whether the severity of the co-morbidity was perceived to impact physical function in patients following a hip fracture. RESULTS: Seventeen out of 20 respondents completed the questionnaire. The presence and severity of arthritis was 'strongly' believed to predict physical function in those with hip fracture (69 and 85.7 %, respectively). Respondents 'agreed' (range 53-73 %) that 10/18 diagnoses would predict changes in physical function following hip fracture treatment. Whereas, 63 % of the practitioners'strongly disagreed' that diabetes types I and II would change physical function scores. Furthermore, dementia was listed as an additional diagnosis that would affect physical function. CONCLUSION: The FCI may provide a useful instrument to predict functional outcome after hip fracture; however, the index may need to be modified for this specific population.

Methodological challenges in the use of hip-specific composite outcomes: linking measurements from hip fracture trials to the International Classification of Functioning, Disability and Health Framework.

INTRODUCTION: The prevalence of hip-specific outcome measures in randomized trials reflects what directs our outcome assessment following a hip fracture. The present study provides an overview on the most commonly-used hip-specific outcome instruments used for postoperative assessment of hip fracture with respect to their covered contents. This can facilitate the selection of appropriate items for specific purposes in clinical as well as research settings. METHODS: We used the International Classification of Functioning, Disability and Health (ICF) model to distinguish concepts within the instrument. All items from the questionnaires were categorized into one of three categories using the ICF linking rules for a standardized approach. The hip-specific composites measures were also compared to other types of prevalent measures: generic and patient-based instruments. RESULTS: All of the items in the instruments could be mapped to the ICF. We report the highest frequency of ICF activity and participation (71%) within the Harris hip score (HHS) which is similar to the frequency of ICF content found in the generic measures (82%). Hip-specific composites focused mostly on walking and moving long and short distances, while in patient-reported measures there was a concentration on the concept of sensation of pain and pain in body parts. DISCUSSION AND CONCLUSION: The prevalent use of the HHS, over the other hip-specific instruments, could be attributed to its likeness in concept to other generic measures. The dominance of the ICF category of activity and participation reflects what is important to clinicians treating a hip fracture. Composite scores remain problematic as they cut across different ICF concepts. As long as the popularity of composite scoring systems continues, an overall score may not represent the true patient preferences and concerns in clinical trials. Future studies could apply the results from this study for the creation of an ICF category-based item banking or investigators could operationalize the ICF categories within these candidate measures for specific interventions.

Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

INTRODUCTION: Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. METHODS: We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. RESULTS: We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. CONCLUSION: We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

The need to standardize functional outcome in randomized trials of hip fracture: a review using the ICF framework.

OBJECTIVES: The choice of ideal outcome assessment is complex with the ever-growing number of possible instruments found in the orthopaedic literature. It is critical to reach a worldwide consensus approach in identifying the specific measures to be used in study designs for evaluating treatment of patients with hip fracture. In this article, we present results from a systematic review of the measures being used currently to assess functional outcome in randomized trials. We used the International Classification of Functioning Disability and Health (ICF) framework for conceptualizing outcome after hip fracture trauma from a body, individual, and societal perspective. DATA SOURCES: Relevant articles from 1980 to 2008 (week 52) were found using PubMed, Ovid MEDLINE, Cochrane, Ovid Healthstar, EMBASE, and CINAHL. STUDY SELECTION: Studies were included if (1) patients were older than 65 years and managed postoperatively after a hip fracture and (2) the studies were randomized and in the English language. DATA EXTRACTION: The intervention, sample size, follow-up, intention-to-treat analysis, mode of administration, and functional outcome domains and concepts using the ICF were recorded for each study. DATA SYNTHESIS: Ninety-seven studies containing 82 different instruments for assessing functional outcome were included. Those trials with a low risk of bias relied upon standardized patient-reported outcomes when compared with those trials with a high risk of bias that adopted more investigator-developed instruments. Nineteen percent of the trials used the Harris hip score, 14% used the Katz activities of daily living index, and 10% used the new mobility score. CONCLUSIONS: We believe that standardized patient-reported outcomes should be used to assess functional outcome after hip fracture and more rigor is needed when conducting surgical trials in this area. Variation in outcome measures across trials leads to several problems. Clinicians may not be able to interpret their findings when different measures are used. Researchers will not be able to calculate summary treatment effects. Our findings are based on a process for delineating the categories from within the ICF framework that may serve, in the future, as a comprehensive foundation of content for outcomes in the area of hip fractures.

Problematic issues and conclusive remarks.

Since 2002, there has been a paradigm shift in the prevention and treatment of osteoporotic fractures. The focus now is on preventing fragility fractures and their associated complications rather than on treating low bone mineral density. Evidence shows that many patients with fractures do not undergo appropriate assessment or treatment. It is important to have an integrated approach in the overall patient management in order to address this care gap for high-risk patients.

Outcome assessment in hip fracture: evaluation of the practicality of commonly-used outcomes in hip fracture studies.

INTRODUCTION: Elderly patients are at a major risk for a first hip fracture. The decrease in bone mineral density may account for 60-85% of the variability in fracture risk. Other contributing factors for hip fractures include cognitive impairment as well as impaired mobility and visual depth perception. Dizziness and poor or fair self-perceived health care characteristics are predictive of a second hip fracture. In general, patients over the age of 65 years admitted to a geriatric rehabilitation unit after proximal hip fracture have complex multiple interacting pathologies with 78% having significant co-morbidity. Because of the added co-morbidity, we believed that the choice of outcome assessment in hip fracture studies would reflect the practical qualities of an instrument. The purpose of our study was to evaluate the practicality of functional outcome instruments found in the current literature in the elderly following postoperative hip fracture. METHODS: We coded the instruments according to the International Classification of Functioning, Disability and Health conceptual framework. 24 different instruments measuring Body Function, 13 instruments evaluating Activity and Participation and 8 composite scores were identified. Practicality was evaluated using four dimensions: respondent burden, examiner burden, score distribution and format compatibility. RESULTS: All instruments evaluating Body Function were performance-based and used exclusively in rehabilitation trials. Performance-based instruments also correlated with a high score in examiner and respondent burden. Surgical trials mostly adopted the Harris hip score which was rated low in examiner and respondent burden. The SF-36 was rated with an adequate score distribution but low in format compatibility. DISCUSSION AND CONCLUSION: An instrument with low respondent burden and minimal examiner burden demonstrated better potential for being applicable in randomized trials with elderly hip fracture patients presenting with co-morbidities. In the future we believe that practical qualities should also be considered when developing or utilizing instruments.

Can we improve fixation and outcomes? Use of bone substitutes.

Hip fractures secondary to osteoporosis are common in the elderly. Stabilizing these fractures until union is achieved is a challenge due to poor bone stock and insufficient purchase of the implant to the bone. The reported high rate of complications has prompted extensive research in the development of fixation techniques. Furthermore, manipulation of both the local fracture environment in terms of application of growth factors, scaffolds, and mesenchymal cells and the systemic administration of agents promoting bone formation and bone strength has been considered as a treatment option with promising results. There are only a few evidence-based studies reporting on fixation augmentation techniques. This article reports on the efficacy of bone graft substitutes for the fixation of hip fractures, in particular calcium phosphates, which have been used as granules, cements, and implant coatings.

Fracture healing and drug therapies in osteoporosis.

Fracture repair has not been fully optimised and there is opportunity to increase the healing rate and reduce the number of complications using pharmacological means. While most anti-osteoporosis drugs have been widely tested for their ability to decrease the risk of osteoporotic fractures, fragility fractures still occur in patients under medical intervention. The primary purpose of this systematic review is to understand these underlying mechanisms between bone and drug therapies in osteoporosis and the overall promotion of fracture healing and callus formation. Databases such as MEDLINE, Google Scholar, EMBASE and CINAHL were searched and nine articles met all inclusion criteria. We report that there is still large controversy and a need for clinical trials to address the deficiencies found in animal models. There is no clear evidence yet as to whether complications during the course of healing are attributable to implant anchorage problems in osteoporotic bone or to possibly delayed healing in the aged.

Fixation of HA-coated unicortical locking screws in a sheep gap model: a comparative biomechanical study.

OBJECTIVES: To evaluate whether fixing a locking compression plate (LCP) with hydroxyapatite (HA)-coated screws provides improved biomechanical fixation and healing compared with standard screws under loaded conditions. METHODS: Ten sheep were randomly divided into 2 groups. A resection osteotomy of 8 mm was performed in the sheep's right tibiae. Five tibiae were fixed with a 9-hole LCP and 8 standard unicortical locking screws (Group Non-HA), and 5 tibiae were fixed with a 9-hole LCP and 8 HA-coated unicortical locking screws (Group HA). All screws were implanted at the same insertion torque of 4000 Nmm. Three months after surgery, all the sheep were euthanized. Bone segments after screw removal were randomly chosen from each group for histologic analysis (Group Non-HA=5, Group HA=5). RESULTS: Mean screw extraction torque was 438+/-288 Nmm in Group Non-HA (n=40) and 2317+/-657 Nmm in Group HA (n=40) (P<0.0005). The tibial torque resistance of the resected tibiae was 24+/-8 Nm in Group Non-HA (n=5) and 31+/-3 in Group HA (n=5) (P=0.045). In Group Non-HA, histology showed bone resorption and fibrous tissue encapsulation in all the samples, but this was not found in any of the Group HA samples. CONCLUSIONS: This study shows that an LCP with HA-coated screws provides improved biomechanical fixation than an LCP with similar standard screws as shown by a 5-fold greater screw extraction torque (P<0.0005). Furthermore, the higher tibial torque resistance is potentially beneficial for improved gap healing, as shown by higher tibial torque resistance.

Alendronate improves screw fixation in osteoporotic bone.

BACKGROUND: Animal studies have demonstrated the efficacy of the use of bisphosphonates to enhance screw fixation in bone. In this prospective, randomized study of pertrochanteric fractures treated with external fixation, we tested whether systemic administration of bisphosphonates would improve the fixation of hydroxyapatite-coated screws implanted in osteoporotic bone. METHODS: Sixteen consecutive patients with a pertrochanteric fracture were selected. Inclusion criteria were female gender, an age of at least sixty-five years, and a bone mineral density T-score of less than -2.5 standard deviations. Exclusion criteria included bisphosphonate treatment during the two-year period prior to the fracture. Fractures were fixed with a pertrochanteric fixator and four hydroxyapatite-coated pins. Two pins were implanted in the femoral head (pin positions 1 and 2), and two were placed in the femoral diaphysis (pin positions 3 and 4). The patients were randomized either to therapy with alendronate for a three-month postoperative period (Group A) or to no therapy (Group B). The Group-A patients received an oral dose of 70 mg of alendronate per week. The fixators were removed after three months. RESULTS: All of the fractures healed, and no loss of reduction, nonunion, or delayed union was observed. The combined mean extraction torque (and standard deviation) of the pins implanted at positions 1 and 2 (cancellous bone) was 2558 +/- 1103 N/mm in Group A and 1171 +/- 480 N/mm in Group B (p < 0.0005). The combined mean extraction torque of the pins implanted at positions 3 and 4 (cortical bone) was 4327 +/- 1720 N/mm in Group A and 4075 +/- 1022 N/mm in Group B. CONCLUSIONS: These data show that weekly systemic administration of alendronate improves pin fixation in cancellous bone in elderly female patients with osteoporosis. We observed a twofold increase in extraction torque with the pins implanted in cancellous bone. These results support the use of alendronate in the treatment of osteoporotic pertrochanteric fractures to improve screw fixation in the femoral head.

Hydroxyapatite-coated external fixation pins.

The aim of this review is to report on studies of hydroxyapatite-coated external fixation pins as a solution to enhance pin fixation. In a highly loaded animal study, three tapered pin types were compared: Type A uncoated, Type B coated with hydroxyapatite and Type C coated with titanium. There was a 13-fold increase in the extraction torque of Type B pins compared with Type A, and a twofold increase compared with Type C pins. Extraction torque was significantly lower compared with the corresponding insertion torque in both Types A (p < 0.001) and C (p = 0.003). Conversely, with the hydroxyapatite-coated pins there was no difference between extraction and insertion torque. In a clinical study of 76 external fixation pins in 19 patients treated with hemicallotasis for osteoarthritis on the medial side of the knee, pin insertion and extraction torque forces were measured. The patients were randomized to be treated with either standard tapered pins or tapered pins coated with hydroxyapatite. Extraction torque of the hydroxyapatite-coated pins was higher than the extraction torque of the standard pins in both cancellous and cortical bone (p < 0.005). In a prospective, randomized clinical study of osteoporotic wrist fractures, extraction torque of the coated pins was higher than with standard pins (p < 0.0001). These studies demonstrate that with the use of hydroxyapatite-coated pins, no deterioration of pin fixation occurs, and that there is no significant pin loosening and infection, regardless of bone type and loading conditions.

Dynamic hip screw compared with external fixation for treatment of osteoporotic pertrochanteric fractures. A prospective, randomized study.

BACKGROUND: Although the use of a sliding hip screw is considered to be the preferred treatment for pertrochanteric femoral fractures, we theorized that external fixation could produce clinical outcomes equal to, if not better than, the outcomes obtained with conventional treatment. Furthermore, because external fixation is minimally invasive, we expected a lower rate of morbidity and a reduced need for blood transfusions. Therefore, we compared the two treatments in a clinical trial of elderly patients with pertrochanteric fracture. METHODS: Forty consecutive elderly female patients who had a pertrochanteric fracture were randomized to be treated with either fixation with a 135 degrees four-hole sliding hip screw (Group A) or an external fixation device with hydroxyapatite-coated pins (Group B). The inclusion criteria were female gender, an age of at least sixty-five years, an AO/OTA type-A1 or A2 fracture, and a bone mineral density T-score of less than -2.5. There were no differences in patient age, fracture type, bone mineral density, comorbidities, length of hospital stay, or quality of reduction between the two groups. RESULTS: The average intraoperative time (and standard deviation) was 64 +/- 6 minutes in Group A and 34 +/- 5 minutes in Group B (p < 0.005). The average number of units of blood transfused postoperatively was 2.0 +/- 0.1 in Group A and none in Group B (p < 0.0001). Group B had less pain five days postoperatively (p < 0.05). Varus collapse of the fracture at six months averaged 6 degrees +/- 8 degrees in Group A and 2 degrees 1 degrees in Group B (p < 0.002). No pin-track infections occurred in Group B. The average Harris hip score at six months was 62 +/- 19 points in Group A and 63 +/- 17 points in Group B. CONCLUSIONS: This study showed that external fixation with hydroxyapatite-coated pins is an effective treatment for this fracture in this patient population. The operative time is brief, the blood loss is minimal, the fixation is adequate, and the reduction is maintained over time.