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Effects of a 2-Year Primary Care Lifestyle Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial.
Höchsmann, C, Dorling, JL, Martin, CK, Newton, RL, Apolzan, JW, Myers, CA, Denstel, KD, Mire, EF, Johnson, WD, Zhang, D, et al
Circulation. 2021;(12):1202-1214
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Abstract
BACKGROUND Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. METHODS The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. RESULTS As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. CONCLUSIONS A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.
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An electronic decision support-based complex intervention to improve management of cardiovascular risk in primary health care: a cluster randomised trial (INTEGRATE).
Webster, R, Usherwood, T, Joshi, R, Saini, B, Armour, C, Critchley, S, Di Tanna, GL, Galgey, S, Hespe, CM, Jan, S, et al
The Medical journal of Australia. 2021;(9):420-427
Abstract
OBJECTIVES To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. DESIGN, SETTING Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 - 13 September 2019. PARTICIPANTS General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. INTERVENTION Electronic point-of-care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy-based medication adherence program. MAIN OUTCOME MEASURES Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low-density lipoprotein (LDL) cholesterol goals at study end. RESULTS After a median 15 months' follow-up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85-1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). CONCLUSIONS Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ACTRN12616000233426 (prospective).
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Food Insecurity and Weight Loss in an Underserved Primary Care Population: A Post Hoc Analysis of a Cluster Randomized Trial.
Myers, CA, Martin, CK, Apolzan, JW, Arnold, CL, Davis, TC, Johnson, WD, Katzmarzyk, PT, ,
Annals of internal medicine. 2021;(7):1032-1034
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Screening for diabetic retinopathy with different levels of financial incentive in a randomized controlled trial.
Lian, JX, McGhee, SM, So, C, Kwong, ASK, Sum, R, Tsui, WWS, Chao, DVK, Chan, JCH
Journal of diabetes investigation. 2021;(9):1632-1641
Abstract
AIMS/INTRODUCTION To examine the impact of different levels of financial incentive in terms of fee subsidization on diabetic retinopathy screening in the private primary care setting in Hong Kong. MATERIALS AND METHODS All general practitioners working in the private sector and registered in two electronic public databases were invited to participate. Consecutive patients with diabetes mellitus were then recruited by the participating practitioners. The recruited participants were randomly allocated to one of three screening groups with different fee levels (HK$0, HK$150 [US$19], HK$300 [US$39]) in a randomized controlled trial. Screening uptake and severity of diabetic retinopathy detected were compared. RESULTS Out of 1,688 eligible practitioners, 105 participated and invited 402 patients, with 239 initially agreeing to participate (59.5%). After randomization, 78, 75 and 76 participants in the HK$0, HK$150 and HK$300 fee groups, respectively, reconfirmed their participation and were offered screening at the relevant fee. The uptake of screening was 79.5% (62/78), 81.3% (61/75) and 63.2% (48/76), in the HK$0, HK$150 and HK$300 groups, respectively (P < 0.018). Being in the HK$150 fee group was associated with higher uptake of screening than being in the HK$300 fee group (odds ratio 2.31, P = 0.039). No significant difference was found in the prevalence of any diabetic retinopathy (33.9%, 27.9% and 37.5%, P = 0.378) or sight-threatening diabetic retinopathy (4.8%, 8.2% and 16.7%; P = 0.092) among the groups. CONCLUSION A screening fee of HK$150, representing approximately a half subsidy, appears to be as effective in maximizing uptake as a full subsidy (HK$0) and without deterring those at high risk of diabetic retinopathy from screening.
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Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial.
Peralta, CA, Livaudais-Toman, J, Stebbins, M, Lo, L, Robinson, A, Pathak, S, Scherzer, R, Karliner, LS
American journal of kidney diseases : the official journal of the National Kidney Foundation. 2020;(5):636-644
Abstract
RATIONALE & OBJECTIVE Most adults with chronic kidney disease (CKD) in the United States are cared for by primary care providers (PCPs). We evaluated the feasibility and preliminary effectiveness of an electronic clinical decision support system (eCDSS) within the electronic health record with or without pharmacist follow-up to improve the management of CKD in primary care. STUDY DESIGN Pragmatic cluster-randomized trial. SETTING & PARTICIPANTS 524 adults with confirmed creatinine-based estimated glomerular filtration rates of 30 to 59mL/min/1.73m2 cared for by 80 PCPs at the University of California San Francisco. Electronic health record data were used for patient identification, intervention deployment, and outcomes ascertainment. INTERVENTIONS Each PCP's eligible patients were randomly assigned as a group into 1 of 3 treatment arms: (1) usual care; (2) eCDSS: testing of creatinine, cystatin C, and urinary albumin-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium, and proteinuria management, cardiovascular risk reduction, and patient education; or (3) eCDSS plus pharmacist counseling (eCDSS-PLUS). OUTCOMES The primary clinical outcome was change in blood pressure over 12 months. Secondary outcomes were PCP awareness of CKD and use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and statin therapy. RESULTS All 80 eligible PCPs participated. Mean patient age was 70 years, 47% were nonwhite, and mean estimated glomerular filtration rate was 56±0.6mL/min/1.73m2. Among patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed laboratory measurements and 138 (41%) had laboratory measurements followed by a PCP visit with eCDSS deployment. eCDSS was opened by the PCP for 102 (74%) patients, with at least 1 suggested order signed for 83 of these 102 (81%). Changes in systolic blood pressure were-2.1±1.5mm Hg with usual care, -2.8±1.8mm Hg with eCDSS, and -1.1±1.1 with eCDSS-PLUS (P=0.7). PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS-PLUS (P=0.09). In as-treated analyses, PCP awareness of CKD was significantly greater with eCDSS and eCDSS-PLUS (73% and 69%) versus usual care (47%; P=0.002). LIMITATIONS Recruitment of smaller than intended sample size and limited uptake of the testing component of the intervention. CONCLUSIONS Although we were unable to demonstrate the effectiveness of eCDSS to lower blood pressure and uptake of the eCDSS was limited by low testing rates, eCDSS use was high when laboratory measurements were available and was associated with higher PCP awareness of CKD. FUNDING Grants from government (National Institutes of Health) and not-for-profit (American Heart Association) entities. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT02925962.
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Acceptability of the "MOVEdiabetes" physical activity intervention in diabetes primary care settings in Oman: findings from participants and practitioners.
Alghafri, TS, Al Harthi, SM, Al-Ajmi, F, Al-Farsi, Y, Craigie, AM, Bannerman, E, Anderson, AS
BMC public health. 2020;(1):887
Abstract
BACKGROUND Adequate physical activity (PA) is considered essential in diabetes management. However, evidence on the best method of promoting PA within diabetes care is inconclusive. The current work identifies perceptions on the acceptability of Intervention Group Participants (IGP) and Project Officers (POs) about the "MOVEdiabetes" intervention programme aimed at increasing PA in adults with type 2 diabetes in Oman (a retrospectively registered trial). METHODS The "MOVEdiabetes" programme (PA consultations, pedometers and WhatsApp messages) was delivered by the POs (primary health care practitioners) in four primary care centres within a one-year cluster randomised control trial. Recruitment and retention were measured from trial attendance records. Programme satisfaction, appropriateness, and content suitability were assessed using exit surveys for both the IGP (interview based) and POs (self-administered). Open text questions on perceptions to the study programme were also included. RESULTS Participants were randomised to an intervention group (IG, n = 122) or comparison group (CG, n = 110). The overall retention rate at three and 12 months was 92.7% [110(90.2%) IG vs 105(95.5%) CG] and 75% [82(67.2%) IG vs 92(83.6%) CG] respectively. Most (n = 14, 87.5%) POs and more than half (n = 49, 59.8%) IGP perceived the programme as very appropriate and many reported that they were "quite/ very satisfied" with the programme (n = 16, 100% PO's and n = 71, 86.6% IGP). Two thirds (n = 55, 66.0%) of IGP were very/quite likely to recommend the programme to others. PA consultations, use of pedometers and Whatsapp messages were well perceived by all. Participants recommended the inclusion of dietary advice and PA promotion for the general public. Exploring PA facilities within the community was suggested by POs. CONCLUSIONS The "MOVEdiabetes" programme achieved a high retention rate and was perceived as satisfactory and appropriate. Results from this study suggest that it is worthwhile exploring the use of the "MOVEdiabetes" programme in clinical practice and further community links. TRIAL REGISTRATION International Standard Randomised Controlled Trials No: ISRCTN14425284. Registered retrospectively on 12th April 2016.
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Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool.
Simione, M, Sharifi, M, Gerber, MW, Marshall, R, Avalon, E, Fiechtner, L, Horan, C, Orav, EJ, Skelton, J, Taveras, EM
Health and quality of life outcomes. 2020;(1):179
Abstract
BACKGROUND Incorporating family-centered care principles into childhood obesity interventions is integral for improved clinical decision making, better follow-through, and more effective communication that leads to better outcomes and greater satisfaction with services. The purpose of this study is to evaluate the psychometric properties of a modified version of the Family Centered-Care Assessment (mFCCA) tool and to assess the family-centeredness of two clinical-community childhood obesity interventions. METHODS Connect for Health was a randomized trial testing the comparative effectiveness of two interventions that enrolled 721 children, ages 2-12 years, with a body mass index (BMI) ≥ 85th percentile. The two arms were (1) enhanced primary care; and (2) enhanced primary care plus contextually-tailored, health coaching. At the end of the one-year intervention, the mFCCA was administered. We used Rasch analyses to assess the tool's psychometrics and examined differences between the groups using multiple linear regression. RESULTS 629 parents completed the mFCCA resulting in an 87% response rate. The mean (SD) age of children was 8.0 (3.0) years. The exploratory factor analysis with 24 items all loaded onto a single factor. The Rasch modeling demonstrated good reliability as evidenced by the person separation reliability coefficient (0.99), and strong validity as evidenced by the range of item difficulty and overall model fit. The mean (SD, range) mFCCA score was 4.14 (0.85, 1-5). Compared to parents of children in the enhanced primary care arm, those whose children were in the enhanced primary care plus health coaching arm had higher mFCCA scores indicating greater perception of family-centeredness (β = 0.61 units [95% CI: 0.49, 0.73]). CONCLUSIONS Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management. TRIAL REGISTRATION Clinicaltrials.gov NCT02124460.
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Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa.
Haskins, L, Chiliza, J, Barker, P, Connolly, C, Phakathi, S, Feeley, A, Horwood, C
BMC public health. 2020;(1):318
Abstract
BACKGROUND Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement (QI) intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa. METHODS A three-month intervention comprised of six QI mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1. RESULTS Improvements in some growth monitoring indicators were achieved in intervention clinics compared to control clinics, including measuring the length of the baby (77% vs 63%; p = 0.001) and health workers asking mothers about the child's feeding (74% vs 67%; p = 0.003), but the proportion of mothers who received feeding advice remained unchanged (38% vs 35%; p = 0.48). Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001). Discussions with the mother about some maternal health services improved: significantly more mothers in the intervention group were asked about HIV (26.5% vs 19.5%; p = 0.009) and family planning (33.5% vs 19.5%; p < 0.001), but this did not result in additional services being provided to mothers at the clinic visit. CONCLUSION This robust evaluation shows significant improvements in coverage of some services, but the QI intervention was unable to achieve the substantial changes required to provide a comprehensive package of services to all mothers and children. We suggest the QI process be adapted to complex under-resourced health systems, building on the strengths of this approach, to provide workable health systems strengthening solutions for scalable implementation. TRIAL REGISTRATION ClinicalTrials.gov NCT04278612. Date of Registration: February 19, 2020. Retrospectively registered.
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Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study.
Bolme, S, Morken, TS, Follestad, T, Sørensen, TL, Austeng, D
Acta ophthalmologica. 2020;(2):139-144
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PURPOSE To test if task shifting of intraocular injections to nurses in a real-world setting can result in similar visual function outcome with equal safety profile. METHOD All patients with either age-related macular degeneration, retinal vein occlusion or diabetic macular oedema remitted to intraocular injections at a tertiary ophthalmology department in Norway between March 2015 and May 2017, were asked to participate. The participants were randomized to either nurse- or physician-administered intraocular injections of anti-vascular endothelial growth factor. The primary outcome measure was change in best-corrected visual acuity from baseline to 1-year follow-up. The mean difference in the primary outcome between the groups was analysed by a noninferiority test with a margin of three letters in disfavour of the nurse group. Adverse events were recorded. RESULTS Three hundred and forty-two patients entered the study. Two hundred and fifty-nine completed the 1-year follow-up and were included in the study sample for the analysis of the primary outcome. Nurse-administered intraocular injections were noninferior to physician-administered injections with 0.7 and 1.6 letters gained, respectively (95% CI of the mean difference, -2.9 to 1.0; p = 0.019, one-sided t-test). Two thousand and seventy-seven injections and three ocular adverse events were recorded. CONCLUSION Task shifting of intraocular injections to nurses can be performed without increased risk to visual function. Such a task shift can alleviate the burden of performing intraocular injections in ophthalmology departments. To our knowledge, this is the first RCT on task shifting of a surgical procedure from physicians to nurses in a high-income country.
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Study protocol for the road to hierarchical diabetes management at primary care (ROADMAP) study in China: a cluster randomised controlled trial.
Jia, W, Zhang, P, Duolikun, N, Zhu, D, Li, H, Bao, Y, Li, X, Liu, Y, ,
BMJ open. 2020;(1):e032734
Abstract
INTRODUCTION Diabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts. METHODS AND ANALYSIS This is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)). ETHICS AND DISSEMINATION The trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms. TRIAL REGISTRATION NUMBER ChiCTR-IOC-17011325.