Patients In Intervention Clinics Research Articles

S-34-2: TRENDS IN HYPERTENSION IN SINGAPORE AND EVIDENCE-BASED SOLUTIONS

Trends data on Singapore from the Institute of Health Metrics and Evaluation show that the attributable risk of cardiovascular disease (CVD) from high blood pressure (BP) declined from 1990 to 2010, then plateaued till about 2015, and has increased over the last five years. Moreover, several data sources, including the multi-institutional Sing Health Diabetes Registry, indicate a worsening in BP control from 2013 to 2019. Singapore acute myocardial infarction (AMI) registry shows a rise in the incidence of AMI during this time. These alarming trends collectively call for immediate action to improve BP control. The SingHypertension cluster randomized controlled trial evaluated a multicomponent intervention versus usual care in eight polyclinics in Singapore: 4 clinics were randomized to intervention and 4 to usual care. 916 adults with uncontrolled hypertension were enrolled. The intervention comprised of physicians trained in risk-based treatment, subsidized single-pill combination (SPC) medications, nurse-delivered motivational conversation, and telephone follow-ups. At 24 months, the intervention led to improved BP control, lowered cardiovascular risk and albuminuria, and better quality of life in patients in intervention clinics compared to those in than care. Wide-scale implementation of a multicomponent intervention such the SingHypertension is likely to reduce hypertension-related morbidity and mortality in Singapore and possibly many other countries.

Effect of Clinical Decision Support at Community Health Centers on the Risk of Cardiovascular Disease

Management of cardiovascular disease (CVD) risk in socioeconomically vulnerable patients is suboptimal; better risk factor control could improve CVD outcomes. To evaluate the impact of a clinical decision support system (CDSS) targeting CVD risk in community health centers (CHCs). This cluster randomized clinical trial included 70 CHC clinics randomized to an intervention group (42 clinics; 8 organizations) or a control group that received no intervention (28 clinics; 7 organizations) from September 20, 2018, to March 15, 2020. Randomization was by CHC organization accounting for organization size. Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention. A point-of-care CDSS displaying real-time CVD risk factor control data and personalized, prioritized evidence-based care recommendations. One-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk that was considered achievable if 6 key risk factors reached evidence-based levels of control). Among the 18 578 eligible patients (9490 [51.1%] women; mean [SD] age, 58.7 [8.8] years), patients seen in control clinics (n = 7419) had higher mean (SD) baseline CVD risk (16.6% [12.8%]) than patients seen in intervention clinics (n = 11 159) (15.6% [12.3%]; P < .001); baseline reversible CVD risk was similarly higher among patients seen in control clinics. The CDSS was used at 19.8% of 91 988 eligible intervention clinic encounters. No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001). However, when the CDSS was used, both risk measures decreased more among patients with high baseline risk in intervention than control clinics; notably, mean reversible risk decreased by an absolute 4.4% (95% CI, -5.2% to -3.7%) among patients in intervention clinics compared with 2.7% (95% CI, -3.4% to -1.9%) among patients in control clinics (P = .001). The CDSS had low use rates and failed to improve CVD risk in the overall population but appeared to have a benefit on CVD risk when it was consistently used for patients with high baseline risk treated in CHCs. Despite some limitations, these results provide preliminary evidence that this technology has the potential to improve clinical care in socioeconomically vulnerable patients with high CVD risk. ClinicalTrials.gov Identifier: NCT03001713.

A systematic intervention to improve serious illness communication in primary care: Effect on expenses at the end of life

BackgroundAt a population level, conversations between clinicians and seriously ill patients exploring patients’ goals and values can drive high-value healthcare, improving patient outcomes and reducing spending. MethodsWe examined the impact of a quality improvement intervention to drive better communication on total medical expenses in a high-risk care management program. We present our analysis of secondary expense outcomes from a prospective implementation trial of the Serious Illness Care Program, which includes clinician training, coaching, tools, and system interventions. We included patients who died between January 2014 and September 2016 who were selected for serious illness conversations, using the “Surprise Question,” as part of implementation of the program in fourteen primary care clinics. ResultsWe evaluated 124 patients and observed no differences in total medical expenses between intervention and comparison clinic patients. When comparing patients in intervention clinics who did and did not have conversations, we observed lower average monthly expenses over the last 6 ($6297 vs. $8,876, p = 0.0363) and 3 months ($7263 vs. $11,406, p = 0.0237) of life for patients who had conversations. ConclusionsPossible savings observed in this study are similar in magnitude to previous studies in advance care planning and specialty palliative care but occur earlier in the disease course and in the context of documented conversations and a comprehensive, interprofessional case management program. ImplicationsPrograms designed to drive more, earlier, and better serious illness communication hold the potential to reduce costs. Level of evidenceProspectively designed trial, non-randomized sample, analysis of secondary outcomes.

A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania.

IntroductionIn October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic.MethodsWe implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment tracking and community outreach systems on the rate of missed appointments and number of days covered by dispensed antiretroviral medications among women previously established on antiretroviral therapy. We used interrupted time series analysis to assess study outcomes. Clinic staff and patients in intervention clinics were aware of the intervention because of change in clinic procedures; data collectors knew the study group assignment.ResultsThree months pre-intervention, we identified 1924 and 1226 patients established on antiretroviral therapy for six months or more in intervention and control clinics, respectively, of whom 83.4% and 86.9% had one or more post-intervention visits. The unadjusted rate of missed visits declined from 36.5% to 34.4% in intervention clinics and increased from 38.9% to 45.5% in control clinics following the intervention. Interrupted time series analyses demonstrated a net decrease of 13.7% (95% CI [-15.4,-12.1]) for missed visits at six months post-intervention. Similar differential changes were observed for visits missed by 3, 7, 15, or 60 days.ConclusionAppointment-tracking and community outreach significantly improved appointment-keeping for women on antiretroviral therapy. The facility staff controlled their workload better, identified missing patients rapidly, and worked with existing community organizations. There is now enough evidence to scale up this approach to all antiretroviral therapy and Option B+ reproductive and child health clinics in Tanzania as well as to evaluate the intervention in medical clinics that treat other chronic health conditions.Trial registrationRegistry for International Development Impact Evaluations ID-55310280d8757

The Effectiveness of a Physician-Only and Physician-Patient Intervention on Colorectal Cancer Screening Discussions Between Providers and African American and Latino Patients.

Physician recommendation of colorectal cancer (CRC) screening is a critical facilitator of screening completion. Providing patients a choice of screening options may increase CRC screening completion, particularly among racial and ethnic minorities. Our purpose was to assess the effectiveness of physician-only and physician-patient interventions on increasing rates of CRC screening discussions as compared to usual care. This study was quasi-experimental. Clinics were allocated to intervention or usual care; patients in intervention clinics were randomized to receipt of patient intervention. Patients aged 50 to 75 years, due for CRC screening, receiving care at either a federally qualified health care center or an academic health center participated in the study. Intervention physicians received continuous quality improvement and communication skills training. Intervention patients watched an educational video immediately before their appointment. Rates of patient-reported 1) CRC screening discussions, and 2) discussions of more than one screening test. The physician-patient intervention (n = 167) resulted in higher rates of CRC screening discussions compared to both physician-only intervention (n = 183; 61.1 % vs.50.3 %, p = 0.008) and usual care (n = 153; 61.1 % vs. 34.0 % p = 0.03). More discussions of specific CRC screening tests and discussions of more than one test occurred in the intervention arms than in usual care (44.6 % vs. 22.9 %,p = 0.03) and (5.1 % vs. 2.0 %, p = 0.036), respectively, but discussion of more than one test was uncommon. Across all arms, 143 patients (28.4 %) reported discussion of colonoscopy only; 21 (4.2 %) reported discussion of both colonoscopy and stool tests. Compared to usual care and a physician-only intervention, a physician-patient intervention increased rates of CRC screening discussions, yet discussions overwhelmingly focused solely on colonoscopy. In underserved patient populations where access to colonoscopy may be limited, interventions encouraging discussions of both stool tests and colonoscopy may be needed.

Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial

BackgroundPoverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa.MethodsThis was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n = 2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n = 1,984) received usual tuberculosis care.ResultsIntention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P = 0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose–response relationship between frequency of receipt of the voucher and treatment success (P <0.001).ConclusionsOur pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it.Trial registrationCurrent Controlled Trials ISRCTN50689131

The effect of the Talking Diabetes consulting skills intervention on glycaemic control and quality of life in children with type 1 diabetes: cluster randomised controlled trial (DEPICTED study)

Objective To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams.Design Pragmatic cluster randomised controlled trial.Setting 26 UK secondary and tertiary care...

Predictors of Antihypertensive Medication Adherence in Two Urban Health-Care Systems

Most studies on patient-related predictors of adherence used self-reported measures or pharmacy databases to measure adherence. We identified predictors of antihypertensive medication adherence measured by Medication Event Monitoring System (MEMS), the gold standard for adherence assessment, in uncontrolled, predominantly African-American (AA) hypertensives from large urban public and private primary care clinics. As part of the baseline data collection of a cluster-randomized trial for hypertension control, we measured adherence in a random sample of 124 participants using MEMS caps. We also included the data of 52 patients in intervention clinics who subsequently completed MEMS monitoring on referral from their provider. Participants were classified as adherent if they took ≥ 80% of all prescribed doses. Multivariate logistic regression was used to predict adherence. Of 176 patients monitored, 61 (34.6%) took <80% of prescribed doses. AA ethnicity (odds ratio (OR) AA vs. Hispanic = 0.36; 95% confidence interval (CI) 0.15-0.86), female sex (OR = 0.38; 95% CI 0.15-0.91), and public clinics as source of care (OR public clinics vs. private clinics = 0.45; 95% CI 0.20-0.97) were independently associated with lower adherence. Higher adherence was seen in patients monitored by clinician order in the intervention clinics (OR intervention sample vs. random baseline sample = 2.15; 95% CI 0.96-4.81) and diabetic patients (OR = 2.05; 95% CI 1.01-4.15). All analyses were adjusted for education, employment status, and other potentially confounding factors. AA ethnicity, female gender and attending a publicly funded primary care clinic were associated with lower adherence. Whether targeting these groups for special interventions would improve overall adherence needs further study.

Improving Care After Myocardial Infarction Using a 2-Year Internet-Delivered Intervention

Cardiovascular risk reduction in ambulatory patients who survive myocardial infarction (MI) is effective but underused. We sought to evaluate a provider-directed, Internet-delivered intervention to improve cardiovascular management for post-MI outpatients. The Department of Veterans Affairs (VA) MI-Plus study was a cluster-randomized trial involving 168 community-based primary care clinics and 847 providers in 26 states, the Virgin Islands, and Puerto Rico, from January 1, 2002, through December 31, 2008, with the clinic as the randomization unit. We collected administrative data for 15,847 post-MI patients and medical record data for 10,452 of these. A multicomponent, Internet-delivered intervention included quarterly educational modules, practice guidelines, monthly literature summaries, and automated e-mail reminders delivered to providers for 27 months. Main outcome measures included percentage of patients who achieved each of 7 clinical indicators, a composite score of the 7 clinical indicators, and mean low-density lipoprotein cholesterol and hemoglobin A(1c) levels. Clinics had a median of 3 providers (interquartile range, 2-6), with a median of 50.0% of providers (33.3%-66.7%) participating in the study. Patients in intervention clinics had greater improvements (from 70.0% to 85.5%) in the percentages prescribed β-blockers than patients in control clinics (71.9% to 84.0%; adjusted improvement gain for intervention vs control, 2.6%; 95% CI, 0.1%-4.1%). We found nonsignificant differences in improvements favoring patients in intervention clinics for 5 of 6 remaining clinical indicators and levels of low-density lipoprotein cholesterol and hemoglobin A(1c). A longitudinal, Internet-delivered intervention improved only 1 of 7 clinical indicators of cardiovascular management in ambulatory post-MI patients.

Development and evaluation by a cluster randomised trial of a psychosocial intervention in children and teenagers experiencing diabetes: the DEPICTED study

To develop and evaluate a health-care communication training programme to help diabetes health-care professionals (HCPs) counsel their patients more skilfully, particularly in relation to behaviour change. The HCP training was assessed using a pragmatic, cluster randomised controlled trial. The primary and secondary analyses were intention-to-treat comparisons of outcomes using multilevel modelling to allow for cluster (service) and individual effects, and involved two-level linear models. Twenty-six UK paediatric diabetes services. The training was delivered to HCPs (doctors, nurses, dietitians and psychologists) working in paediatric diabetes services and the effectiveness of this training was measured in 693 children aged 4-15 years and families after 1 year (95.3% follow-up). A blended learning programme was informed by a systematic review of the literature, telephone and questionnaire surveys of professional practice, focus groups with children and parents, experimental consultations and three developmental workshops involving a stakeholder group. The programme focused on agenda-setting, flexible styles of communication (particularly guiding) and a menu of strategies using web-based training and practical workshops. The primary trial outcome was a change in glycosylated haemoglobin (HbA1c) levels between the start and finish of a 12-month study period. Secondary trial outcomes included change in quality of life, other clinical [including body mass index (BMI)] and psychosocial measures (assessed at participant level as listed above) and cost (assessed at service level). In addition, patient details (HbA1c levels, height, weight, BMI, insulin regimen), health service contacts and patient-borne costs were recorded at each clinic visit, along with details of who patients consulted with, for how long, and whether or not patients consulted on their own at each visit. Patients and carers were also asked to complete an interim questionnaire assessing patient enablement (or feelings towards clinic visit for younger patients aged 7-10 years) at their first clinic visit following the start of the trial. The cost of the intervention included the cost of training intervention teams. Trained staff showed better skills than control subjects in agenda-setting and consultation strategies, which waned from 4 to 12 months. There was no effect on HbA1c levels (p = 0.5). Patients in intervention clinics experienced a loss of confidence in their ability to manage diabetes, whereas controls showed surprisingly reduced barriers (p = 0.03) and improved adherence (p = 0.05). Patients in intervention clinics reported short-term increased ability (p = 0.04) to cope with diabetes. Parents in the intervention arm experienced greater excitement (p = 0.03) about clinic visits and improved continuity of care (p = 0.01) without the adverse effects seen in their offspring. The mean cost of training was £13,145 per site or £2163 per trainee. There was no significant difference in total NHS costs (including training) between groups (p = 0.1). Diabetes HCPs can be trained to improve consultation skills, but these skills need reinforcing. Over 1 year, no benefits were seen in children, unlike parents, who may be better placed to support their offspring. Further modification of this training is required to improve outcomes that may need to be measured over a longer time to see effects. Current Controlled Trials ISRCTN61568050. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 29. See the HTA programme website for further project information.