Cost-effectiveness analysis of health tapestry, a complex primary care program for older adults: a post-hoc analysis.

BACKGROUND: We initially reported on the cost-effectiveness of a 6-month randomized controlled implementation trial which evaluated Health TAPESTRY, a primary care program for older adults, at the McMaster Family Health Team (FHT) site and 5 other FHT sites in Ontario, Canada. While there were no statistically significant between-group differences in outcomes at month 6 post randomization, positive outcomes were observed at the McMaster FHT site, which recruited 40% (204/512) of the participants. The objective of this post-hoc study was to determine the cost-effectiveness of Health TAPESTRY based on data from the McMaster FHT site. METHODS: Costs included the cost to implement Health TAPESTRY at McMaster as well as healthcare resource consumed, which were costed using publicly available sources. Health-related-quality-of-life was evaluated with the EQ-5L-5L at baseline and at month 6 post randomization. Quality-adjusted-life-years (QALYs) were calculated under an-area-under the curve approach. Unadjusted and adjusted regression analyses (two independent regression analyses on costs and QALYs, seemingly unrelated regression [SUR], net benefit regression) as well as difference-in-difference and propensity score matching (PSM) methods, were used to deal with the non-randomized nature of the trial. Sampling uncertainty inherent to the trial data was estimated using non-parametric bootstrapping. The return on investment (ROI) associated with Health TAPESTRY was calculated. All costs were reported in 2021 Canadian dollars. RESULTS: With an intervention cost of $293/patient, Health TAPESTRY was the preferred strategy in the unadjusted and adjusted analyses. The results of our bootstrap analyses indicated that Health TAPESTRY was cost-effective compared to usual care at commonly accepted WTP thresholds. For example, if decision makers were willing to pay $50,000 per QALY gained, the probability of Health TAPESTRY to be cost effective compared to usual care varied from 0.72 (unadjusted analysis) to 0.96 (SUR) when using a WTP of $50,000/QALY gained. The DID and ROI analyses indicated that Health Tapestry generated a positive ROI. CONCLUSION: Health TAPESTRY was the preferred strategy when implemented at the McMaster FHT. We caution care in interpreting the results because of the post-hoc nature of the analyses and limited sample size based on one site.

Effectiveness of a community paramedic-led health assessment and education initiative in a seniors' residence building: the Community Health Assessment Program through Emergency Medical Services (CHAP-EMS).

BACKGROUND: Seniors living in subsidized housing have lower income, poorer health, and increased risk for cardiometabolic diseases and falls. Seniors also account for more than one third of calls to Emergency Medical Services (EMS). This study examines the effectiveness of the Community Health Assessment Program through EMS (CHAP-EMS) in reducing blood pressure, diabetes risk, and EMS calls. METHODS: Paramedics on modified duty (e.g. injured) conducted weekly, one-on-one drop-in sessions in a common area of one subsidized senior's apartment building in Hamilton, Ontario. Paramedics assessed cardiovascular, diabetes, and fall risk, provided health education, referred participants to local resources, and encouraged participants to return to CHAP-EMS for follow-up. Reports were faxed to the family physician regularly. Blood pressure was collected throughout the one year intervention, while diabetes risk was assessed at baseline and after 6-12 months. EMS call volumes were collected from the Hamilton Paramedic Service for two years pre-intervention and one year during the intervention. RESULTS: There were 79 participants (mean age = 72.2 years) and 1,365 participant visits to CHAP-EMS. The majority were female (68%), high school educated or less (53%), had a family doctor (90%), history of hypertension (58%), high waist circumference (64%), high body mass index (61%), and high stress (53%). Many had low physical activity (42%), high fat intake (33%), low fruit/vegetable intake (30%), and were current smokers (29%). At baseline, 42% of participants had elevated blood pressure. Systolic blood pressure decreased significantly by the participant's 3rd visit to CHAP-EMS and diastolic by the 5th visit (p < .05). At baseline, 19% of participants had diabetes; 67% of those undiagnosed had a moderate or high risk based on the Canadian Diabetes Risk (CANRISK) assessment. 15% of participants dropped one CANRISK category (e.g. high to moderate) during the intervention. EMS call volume decreased 25% during the intervention compared to the previous two years. CONCLUSIONS: CHAP-EMS was associated with a reduction in emergency calls and participant blood pressure and a tendency towards lowered diabetes risk after one year of implementation within a low income subsidized housing building with a history of high EMS calls. TRIAL REGISTRATION: Retrospectively registered on May 12th 2016 with clinicaltrials.gov: NCT02772263.

Osteoporosis knowledge among individuals with recent fragility fracture.

BACKGROUND: To evaluate osteoporosis knowledge among patients with fractures and to evaluate factors associated with osteoporosis knowledge. METHODS: Patients with fragility fractures participated in a telephone interview. Participants were asked what they thought osteoporosis was. Unadjusted odds ratios (OR, 95% CI) were calculated to identify factors associated with a correct definition. Predictors identified in univariate analysis were entered into multivariable logistic regression models. A subset also completed the Facts on Osteoporosis Quiz. RESULTS: One hundred twenty-seven patients (82% women) participated in the study, with mean (SD) age being 67.5 (12.7) years. Ninety-five (75%) respondents gave correct osteoporosis definitions. The odds of an individual providing a correct definition of osteoporosis were higher for those who reported a diagnosis of osteoporosis or those who reported higher education levels, but the odds decreased with increasing age. A total of 49 (39%) respondents completed the Facts on Osteoporosis Quiz; the average score was 13.6 (3.8) of 21. Areas that respondents scored poorly on were related to key risk factors. CONCLUSION: Many patients with fractures are unaware of important risk factors. Education initiatives aimed at improving osteoporosis knowledge should be directed at individuals at high risk of fracture. Nurses and other allied healthcare providers working in fracture clinics, acute care, and rehabilitation settings are in an ideal position to communicate information about osteoporosis and fracture risk to individuals with a recent fragility fracture.

Shifts in expectations: evaluating physicians' perceptions as pharmacists become integrated into family practice.

The objective of this study was to measure how primary care family physicians perceived their own and pharmacists' contributions to medication processes as pharmacists become integrated into primary care group family practices. The 22- item Family Medicine Medication Use Processes Matrix was mailed to physicians in seven sites at the 3rd, 12th and 19th month of pharmacist integration. Paired sample t-tests for the third month results were conducted to compare perceptions between pharmacist and physician contributions. One way repeated measure ANOVA test was conducted to determine significant changes over time. Physicians initially perceived their own contributions to be significantly higher than pharmacists in three subscales: Diagnosis & Prescribing, Monitoring and Administration/Documentation and their own contributions to be significantly lower than the pharmacists in the Education subscale. Over time, physicians perceived increases in the pharmacists' contribution to the Diagnosis & Prescribing, Monitoring and Medication Review subscales and decreases in their own contribution to the Diagnosis & Prescribing and Education subscales. Changes in family physicians' perceptions of pharmacists' contribution demonstrate an initial underestimate of pharmacists' role in primary care family practice and a gradual recognition of expertise and competence. This may have led to increased comfort in sharing aspects of contribution to medication use processes.

Community-based intervention to optimise falls risk management: a randomised controlled trial.

BACKGROUND: falls are the leading causes of accidental death and fragility fractures in older adults. Interventions that assess and reduce falls risk are underutilised. OBJECTIVE: to evaluate the impact of a multifaceted community-based programme aimed at optimising evidence-based management of patients at risk for fall-related fractures. DESIGN: this was a randomised trial performed from 2003 to 2006. SETTING: community-based intervention in Ontario, Canada. PARTICIPANTS: eligible patients were community-dwelling, aged > or =55 years and identified to be at risk for fall-related fractures. A total of 201 patients were allocated to the intervention group or to usual care. INTERVENTION: components of the intervention included assessment of falls risk, functional status and home environment, and patient education. MEASUREMENTS: primary outcome was the implementation of appropriate falls risk assessment at 6 months. Secondary outcomes included falls and fractures at 6 and 12 months. RESULTS: the mean age of participants was 72 years, and 41% had fallen with injury in the previous year. Compared to usual care, the intervention increased the number of referrals made to physiotherapy [21% (21/101) vs 6.0% (6/100); relative risk (RR) 3.47, 95% confidence interval (CI) 1.46-8.22] and occupational therapy [15% (15/101) vs 0%; RR 30.7, 95% CI 1.86 to >500]. At 12 months, the number of falls in the intervention group was greater than in the usual care group [23% (23/101) vs 11% (11/100); RR 2.07, 95% CI 1.07-4.02]. CONCLUSIONS: compared to usual care, a multi-faceted intervention increased referrals to physiotherapy and occupational therapy but did not reduce risk of falls. Similar falls reduction interventions cannot be recommended based on the results of this study.

Osteoporosis risk perceptions among patients who have sustained a fragility fracture.

OBJECTIVE: To explore the perceptions of patients who have sustained a fragility fracture regarding their future fracture risk and the beliefs underlying their perceptions. METHODS: Patients with fragility fracture participated in a telephone interview. Quantitative and qualitative methods were used to characterize patient characteristics and perspectives of future fracture risk. Content analysis of qualitative statements was independently performed by three investigators to identify common themes and contrasting statements, and the findings were discussed to ensure consensus. RESULTS: Consistent themes were identified among participant responses irrespective of whether they responded "yes", "no" or "unsure" when asked whether they were at increased fracture risk: (1) patients' perception of risk was influenced by whether or not they believed they had osteoporosis, which may be altered by interaction with health care providers; (2) patients' had their own perceptions of their bone health; (3) patients' attributed their risk to their own actions or "carefulness"; and (4) patients' had specific beliefs about their fracture and determinants of fracture risk. CONCLUSION: Patients who experience fragility fractures develop perceptions about future fracture risk that are influenced by interactions with health care providers, as well as beliefs about their fracture and beliefs that they can modify their risk. PRACTICE IMPLICATIONS: Health care providers should discuss strategies for fracture prevention with all patients after fragility fracture to ensure that patients understand that participation in preventative behaviours can modify their risk.

Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies.

BACKGROUND: Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially underutilized. This paper outlines the protocol for a pragmatic randomised trial of a multifaceted community-based care program aimed at optimizing the evidence-based management of falls and fractures in patients at risk. DESIGN: 6-month randomised controlled study. METHODS: This population-based study was completed in the Algoma District of Ontario, Canada a geographically vast area with Sault Ste Marie (population 78,000) as its main city. Eligible patients were allocated to an immediate intervention protocol (IP) group, or a delayed intervention protocol (DP) group. The DP group received usual care for 6 months and then was crossed over to receive the interventions. Components of the intervention were directed at the physicians and their patients and included patient-specific recommendations for osteoporosis therapy as outlined by the clinical practice guidelines developed by Osteoporosis Canada, and falls risk assessment and treatment. Two primary outcomes were measured including implementation of appropriate osteoporosis and falls risk management. Secondary outcomes included quality of life and the number of falls, fractures, and hospital admissions over a twelve-month period. The patient is the unit of allocation and analysis. Analyses will be performed on an intention to treat basis. DISCUSSION: This paper outlines the protocol for a pragmatic randomised trial of a multi-faceted, community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis. TRIAL REGISTRATION: This trial has been registered with clinicaltrials.gov (ID: NCT00465387).

Integrating family medicine and pharmacy to advance primary care therapeutics.

The prevalence of suboptimal prescribing of medications is well documented. Patients are often undertreated or not offered therapeutic treatments that are likely to confer benefit. As a result, drug-related hospital admissions are common and often preventable. Improvements to the health-care system are clearly needed in order to maximize the benefits that can be derived from medications. Many countries are changing their primary health-care systems to improve the quality of health-care delivery. One main transformation is the use of multidisciplinary care teams to provide care in a coordinated manner often from the same location or by using the common medical record of the patients. It has been demonstrated that pharmacists can improve prescribing, reduce health-care utilization and medication costs, and contribute to clinical improvements in many chronic medical conditions, such as cardiovascular disease, diabetes, and psychiatric illness. However, the effect of integrating a pharmacist providing general services into a primary care group has not been extensively studied. The Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics (IMPACT) project was designed to provide a real-world demonstration of the feasibility of integrating the pharmacist into primary care office practice. This article provides a description of the IMPACT project participants; the IMPACT practice model and the concepts incorporated in its development; some initial results from the program evaluation; sustainability of the model; and some reflections on the implementation of the practice model.

Frequency of risk factors that potentially increase harm from medications in older adults receiving primary care.

BACKGROUND: Many circumstances elevate patients, especially older adults, risk for drug-related morbidity and misadventures. Understanding the frequency of these situations can help with the design of initiatives to address or alter these circumstances with the aim of reducing medication therapy-related concerns and associated expenditures. OBJECTIVE: To describe the frequency of circumstances that may place older adults at higher risk for drug-related morbidity and misadventures in a large sample of elderly patients visiting family medicine clinics. METHODS: Elderly adults at 7 family medicine practices across Ontario self-completed the 10-item Medication Risk Questionnaire (MRQ). RESULTS: Surveys were completed by 907 patients, with a mean age of 72.4 (SD 10.7) years and a mean number of 4.8 medical conditions (SD 2.3; min-max: 0-14). Many subjects were taking multiple medications (mean 6.9 (SD 3.8; min-max: 0-21)) and over 90% of respondents reported at least one indicator that potentially increases their risk of drug-related morbidity. CONCLUSION: Number of medications, number of medical conditions and number of daily medication doses were the most frequently observed risks for medication-related issues in this large sample of elderly patients visiting family medicine clinics.

Impact of reference-based pricing of nitrates on the use and costs of anti-anginal drugs.

BACKGROUND: Reference-based pricing limits reimbursement for a group of drugs that are deemed therapeutically equivalent to the cost of the lowest-priced product within that group. We estimated the effect of reference-based pricing of nitrate drugs used for long-term prophylaxis on prescribing of and expenditures on nitrates and other anti-anginal drugs dispensed to senior citizens in British Columbia. METHODS: We assessed trends in the monthly volume of prescriptions of anti-anginal drugs and the associated drug ingredient cost paid by the province's publicly funded drug subsidy program, Pharmacare, and by the patients themselves for the period April 1994 to May 1999. Trends in monthly rates of nitrate expenditures per 100,000 senior citizens before the introduction of reference-based pricing were extrapolated to infer what expenditures would have been without the policy. RESULTS: During the 3 1/2 years after reference-based pricing was introduced, Pharmacare expenditures on nitrates prescribed to senior citizens declined by $14.9 million (95% confidence interval $10.7 to $19.1 million). Most of these savings were due to the lower prices that Pharmacare paid for sustained-release nitroglycerin tablets and the nitroglycerin patch, which were the 2 most frequently prescribed nitrates before the introduction of reference-based pricing; $1.2 million (8%) of the savings represented expenditures by senior citizens who purchased drugs that were only partially reimbursed. There were no compensatory increases in expenditures for other anti-anginal drugs. Use of sublingual nitroglycerin--a marker for deteriorating health in patients with angina--did not increase after the introduction of reference-based pricing. The nitroglycerin patch is now the most frequently prescribed nitrate, owing to the fact that Pharmacare resumed the provision of full subsidies for the drug after its manufacturers voluntarily reduced retail prices. INTERPRETATION: Evidence to date suggests that reference-based pricing of nitrates has achieved its primary goal of reducing drug expenditures. The effects of this policy on patient health, associated health care costs and administrative costs remain to be investigated.

Bupropion versus selective serotonin-reuptake inhibitors for treatment of depression.

OBJECTIVE: To compare the benefits and risks of bupropion and selective serotonin-reuptake inhibitors (SSRIs) in adults with depression. DATA SOURCES: MEDLINE (1966-September 1999), Embase (1980-August 1999), PsyclNFO (1887-August 1999), International Pharmaceutical Abstracts (1970-August 1999), and CIANHL databases were searched. References from the selected citations, review articles, and the manufacturer were also screened. STUDY SELECTION: Included studies were randomized, double-blind, controlled trials evaluating bupropion versus SSRIs for depression in adults. Studies were assessed independently in duplicate. Discrepancies were resolved by consensus. DATA ANALYSIS: Data are reported as absolute weighted mean differences or relative risks and 95% confidence intervals comparing bupropion relative to SSRIs. Data not combined are presented qualitatively. DATA SYNTHESIS: Six full-length studies were included of 257 citations identified. SSRI comparators were fluoxetine, sertraline, and paroxetine. No differences in Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impressions Scale for Improvement of illness (CGI-I) were found, but data were not able to be quantitatively combined. The absolute weighted mean differences were 0.10 (95% CI -0.2 to 0.4) for the CGI for Severity of Illness and 0.37 (95% CI -0.85 to 1.6) for the Hamilton Rating Scale for Anxiety measurements. Relative risks of bupropion compared with SSRIs were 0.6 (95% CI 0.41 to 0.89), 0.31 (95% CI 0.16 to 0.57), and 0.27 (95% CI 0.15 to 0.48) for nausea, diarrhea, and somnolence, respectively. Sexual arousal disorder, orgasmic dysfunction, and sexual desire disorder occurred less with bupropion than with SSRIs, with relative risks of 0.46 (95% CI 0.26 to 0.83), 0.22 (95% CI 0.12 to 0.40), and 0.65 (95% CI 0.51 to 0.84), respectively. CONCLUSIONS: Bupropion and SSRIs have similar effectiveness; however, bupropion was associated with less nausea, diarrhea, somnolence, and sexual dysfunction.

A meta-analysis comparing low-molecular-weight heparins with unfractionated heparin in the treatment of venous thromboembolism: examining some unanswered questions regarding location of treatment, product type, and dosing frequency.

OBJECTIVES: To compare the efficacy and safety of unfractionated heparin (UFH) and low-molecular-weight heparins (LMWHs) and to examine current controversies in the treatment of venous thromboembolism (VTE) (ie, setting, product type, and frequency of administration). METHODS: Data were abstracted from MEDLINE, HEALTH, previous reviews, personal files, clinical experts, and conference abstracts. Randomized controlled trials of patients diagnosed with acute VTE that compared LMWHs with UFH were included. Independent duplicate assessment was done for methodological quality and data extraction. Data are reported as pooled relative risks (RRs) and 95% confidence intervals (CIs) comparing LMWHs with UFH as determined by the random effects model. RESULTS: Thirteen studies were included. There was no statistically significant difference in risk between UFH and LMWHs for recurrent VTE (RR, 0.85 [95% CI, 0.65-1.12]), pulmonary embolism (RR, 1.02 [95% CI, 0.64-1.62]), major bleeding (RR, 0.63 [95% CI, 0.37-1.05]), minor bleeding (RR, 1.18 [95% CI, 0.87-1.61]), and thrombocytopenia (RR, 0.85 [95% CI, 0.45-1.62]). There was a statistically significant difference for risk of total mortality (RR, 0.76 [95% CI, 0.59-0.98]) in favor of LMWHs. Inpatient treatment may reduce the risk of major bleeding vs outpatient therapy. Once-daily therapy is as safe and effective as twice-daily therapy when compared indirectly. Different products could not be statistically compared, but qualitative analysis shows that there are no apparent differences in efficacy and safety. CONCLUSIONS: Low-molecular-weight heparins are at least as effective as UFH in preventing recurrent VTE. It is unlikely that LMWHs are superior in the treatment of VTE, but they do show a statistically significant decrease in total mortality. No differences were seen in the development of recurrent VTE dependent on treatment setting. There were no apparent differences between once-daily and twice-daily therapy or among products. Inpatient therapy may be associated with less major bleeding; therefore, if LMWHs are given in the outpatient setting, patients should be rigorously monitored.

Can we use anxiolytics during pregnancy without anxiety?

QUESTIONOne of my patients suffers from anxiety and was using lorazepam to treat it. When she became pregnant, she stopped the medication immediately, but now she is worried about the potential effect on the baby because she was using the drug just after conception. Is this class of drugs safe during pregnancy? What should she do if she needs antianxiety treatment during the rest of her pregnancy?ANSWEREvidence to date from cohort studies did not identify a notable association between use of benzodiazepines and increased risk of major malformations, including oral cleft. In contrast, data from case-control studies show a slightly increased risk of oral cleft. Hence, level 2 ultrasonography is recommended to rule out visible forms of cleft lip. Using benzodiazepines late in pregnancy could cause withdrawal syndrome in newborns.

Benzodiazepine use in pregnancy and major malformations or oral cleft: meta-analysis of cohort and case-control studies.

OBJECTIVE: To determine if exposure to benzodiazepines during the first trimester of pregnancy increases risk of major malformations or cleft lip or palate. DESIGN: Meta-analysis. SETTING: Studies from 1966 to present. SUBJECTS: Studies were located with Medline, Embase, Reprotox, and from references of textbooks, reviews, and included articles. Included studies were original, concurrently controlled studies in any language. INTERVENTIONS: Data extraction and quality assessment were done independently and in duplicate. MAIN OUTCOME MEASURES: Maternal exposure to benzodiazepines in at least the first trimester; incidence of major malformations or oral cleft alone, measured as odds ratios and 95% confidence intervals with a random effects model. RESULTS: Of over 1400 studies reviewed, 74 were retrieved and 23 included. In the analysis of cohort studies fetal exposure to benzodiazepine was not associated with major malformations (odds ratio 0.90; 95% confidence interval 0.61 to 1. 35) or oral cleft (1.19; 0.34 to 4.15). Analysis of case-control studies showed an association between exposure to benzodiazepines and development of major malformations (3.01; 1.32 to 6.84) or oral cleft alone (1.79; 1.13 to 2.82). CONCLUSIONS: Pooled data from cohort studies showed no association between fetal exposure to benzodiazepines and the risk of major malformations or oral cleft. On the basis of pooled data from case-control studies, however, there was a significant increased risk for major malformations or oral cleft alone. Until more research is reported, level 2 ultrasonography should be used to rule out visible forms of cleft lip.