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A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care.

ABSTRACT: Practice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care. Using practice facilitation, the Improved Delivery of Cardiovascular Care (IDOCC) project aimed to improve the delivery of evidence-based cardiovascular care in primary care practices across a large health region. Our goal was to evaluate IDOCC's impact on adherence to processes of care delivery.A pragmatic stepped wedge cluster randomized trial recruiting primary care providers in practices located in Eastern Ontario, Canada (ClinicalTrials.gov: NCT00574808). Participants were randomly assigned by region to one of three steps. Practice facilitators were intended to visit practices every 3-4 (year 1-intensive) or 6-12 weeks (year 2-sustainability) to support changes in practice behavior. The primary outcome was mean adherence to indicators of evidence-based care measured at the patient level. Adherence was assessed by chart review of a randomly selected cohort of 66 patients per practice in each pre-intervention year, as well as in year 1 and year 2 post-intervention.Eighty-four practices (182 physicians) participated. On average, facilitators had 6.6 (min: 2, max: 11) face-to-face visits with practices in year 1 and 2.5 (min: 0 max: 10) visits in year 2. We collected chart data from 5292 patients. After adjustment for patient and provider characteristics, there was a 1.9 % (95 % confidence interval (CI): -2.9 to -0.9 %) and 4.2 % (95 % CI: -5.7 to -2.6 %) absolute decrease in mean adherence from baseline to intensive and sustainability years, respectively.IDOCC did not improve adherence to best-practice guidelines. Our results showed a small statistically significant decrease in mean adherence of questionable clinical significance. Potential reasons for this result include implementation challenges, competing priorities in practices, a broad focus on multiple chronic disease indicators, and use of an overall index of adherence. These results contrast with findings from previously reported facilitation trials and highlight the complexities and challenges of translating research findings into clinical practice.ClinicalTrials.gov NCT00574808.

SUBMITTER: Liddy C

PROVIDER: S-EPMC4625868 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care.

Liddy Clare C Hogg William W Singh Jatinderpreet J Taljaard Monica M Russell Grant G Deri Armstrong Catherine C Akbari Ayub A Dahrouge Simone S Grimshaw Jeremy M JM

Implementation science : IS 20151028

<h4>Background</h4>Practice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care. Using practice facilitation, the Improved Delivery of Cardiovascular Care (IDOCC) project aimed to improve the delivery of evidence-based cardiovascular care in primary care practices across a large health region. Our goal was to evaluate IDOCC's impact on adherence to processes of care delivery.<h4>Methods</h4>A pragmatic stepped wedge cluster randomized t ...[more]

PMID: 26510577

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Project description:BackgroundPractice facilitation (PF), a multifaceted approach in which facilitators (external health care professionals) help family physicians to improve their adoption of best practices, has been highly successful. Improved Delivery of Cardiovascular Care (IDOCC) was an innovative PF trial designed to improve evidence-based care for people who have, or are at risk of, cardiovascular disease (CVD). The intervention was found to be ineffective as assessed by a patient-level composite score based on chart reviews from a subsample of patients (N = 5292). Here, we used population-based administrative data to examine IDOCC's effect on CVD-related hospitalizations.MethodsIDOCC used a pragmatic, stepped wedge cluster randomized controlled design involving primary care providers recruited across Eastern Ontario, Canada. IDOCC's effect on CVD-related hospitalizations was assessed in the 2 years of active intervention and post-intervention years. Marginal and mixed-effects regression analyses were used to account for the study design and to control for patient, physician, and practice characteristics. Secondary and subgroup analyses investigated robustness.ResultsOur sample included 262,996 patient/year observations representing 54,085 unique patients who had, or were at risk of, CVD, from 70 practices. There was a strong decreasing secular trend in CVD-related hospitalizations but no statistically significant effect of IDOCC. Relative to patients in the control condition, patients in the intervention condition were estimated to have 4 % lower odds of CVD-related hospitalizations (adjOR = 0.96, 99 % CI 0.83 to 1.11). The nonsignificant result persisted across robustness analyses.ConclusionsClinical outcomes from administrative databases were examined to form a more complete picture of the (in)effectiveness of a large-scale quality improvement intervention. IDOCC did not have a significant effect on CVD hospitalizations, suggesting that the results from the primary composite adherence score analysis were neither due to choice of outcome nor relatively short follow-up period.Trial registrationClinicalTrials.gov NCT00574808 , registered on 14 December 2007.

Project description:BackgroundCigarette smoking in people with cancer is associated with negative treatment-related outcomes including increased treatment toxicity and complications, medication side effects, decreased performance status and morbidity. Evidence-based smoking cessation care is not routinely provided to patients with cancer. The purpose of this study is to determine the effectiveness of a smoking cessation implementation intervention on abstinence from smoking in people diagnosed with cancer.MethodsA stepped wedge cluster randomised design will be used. All sites begin in the control condition providing treatment as usual. In a randomly generated order, sites will move to the intervention condition. Based on the Theoretical Domains Framework, implementation of Care to Quit will include (i) building the capability and motivation of a critical mass of key clinical staff and identifying champions; and (ii) identifying and implementing cessation care models/pathways. Two thousand one hundred sixty patients with cancer (diagnosed in the prior six months), aged 18+, who report recent combustible tobacco use (past 90 days or in the 30 days prior to cancer diagnosis) and are accessing anti-cancer therapy, will be recruited at nine sites. Assessments will be conducted at baseline and 7-month follow-up. The primary outcome will be 6-month abstinence from smoking. Secondary outcomes include biochemical verification of abstinence from smoking, duration of quit attempts, tobacco consumption, nicotine dependence, provision and receipt of smoking cessation care, mental health and quality of life and cost effectiveness of the intervention.DiscussionThis study will implement best practice smoking cessation care in cancer centres and has the potential for wide dissemination.Trial registrationThe trial is registered with ANZCTR (www.anzctr.org.au): ACTRN ( ACTRN12621000154808 ) prior to the accrual of the first participant and will be updated regularly as per registry guidelines.

Project description:BackgroundHigh levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care.MethodsWe did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192.FindingsBetween March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81-1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56-2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70-2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites.InterpretationA supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies.FundingGovernment of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Project description:Youth living with HIV (YLHIV) report that negative interactions with health care workers (HCWs) affects willingness to return to care. This stepped wedge randomized trial evaluated effectiveness of a standardized patient actor (SP) HCW training intervention on adolescent engagement in care in Kenya. HCWs caring for YLHIV at 24 clinics received training on adolescent care, values clarification, communication, and motivational interviewing, with 7 SP encounters followed by facilitated feedback of videotaped interactions. Facilities were randomized to timing of the intervention. The primary outcome was defined as return within 3 months after first visit (engagement) among YLHIV who were either newly enrolled or who returned to care after >3 months out of care. Visit data was abstracted from electronic medical records. Generalized linear mixed models adjusted for time, being newly enrolled, and clustering by facility. YLHIV were surveyed regarding satisfaction with care. Overall, 139 HCWs were trained, and medical records were abstracted for 4,595 YLHIV. Median YLHIV age was 21 (IQR 19-23); 82% were female, 77% were newly enrolled in care, and 75% returned within 3 months. Half (54%) of trained HCWs remained at their clinics 9 months post-training. YLHIV engagement improved over time (global Wald test, p = 0.10). In adjusted models, the intervention showed no significant effect on engagement [adjusted Prevalence Ratio (aPR) = 0.95, 95% Confidence Interval (CI): 0.88-1.02]. Newly enrolled YLHIV had significantly higher engagement than those with prior lapses in care (aPR = 1.18, 95%CI: 1.05-1.33). Continuous satisfaction with care scores were significantly higher by wave 3 compared to baseline (coefficient = 0.38, 95%CI: 0.19-0.58). Despite provider skill improvement, there was no effect of SP training on YLHIV engagement in care. This may be due to temporal improvements or turnover of trained HCWs. Strategies to retain SP-training benefits need to address HCW turnover. YLHIV with prior gaps in care may need more intensive support. Registration CT #: NCT02928900. https://clinicaltrials.gov/ct2/show/NCT02928900.

Project description:ObjectivesTo examine whether primary care outreach facilitation improves the quality of care for general practice patients from refugee backgrounds.DesignPragmatic, cluster randomised controlled trial, with stepped wedge allocation to early or late intervention groups.Setting, participants31 general practices in three metropolitan areas of Sydney and Melbourne with high levels of refugee resettlement, November 2017 - August 2019.InterventionTrained facilitators made three visits to practices over six months, using structured action plans to help practice teams optimise routines of refugee care.Major outcome measureChange in proportion of patients from refugee backgrounds with documented health assessments (Medicare billing). Secondary outcomes were refugee status recording, interpreter use, and clinician-perceived difficulty in referring patients to appropriate dental, social, settlement, and mental health services.ResultsOur sample comprised 14 633 patients. The intervention was associated with an increase in the proportion of patients with Medicare-billed health assessments during the preceding six months, from 19.1% (95% CI, 18.6-19.5%) to 27.3% (95% CI, 26.7-27.9%; odds ratio, 1.88; 95% CI, 1.42-2.50). The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients. There was no impact on refugee status recording, interpreter use increased modestly, and reported difficulties in refugee-specific referrals to social, settlement and dental services were reduced.ConclusionsLow intensity practice facilitation may improve some aspects of primary care for people from refugee backgrounds. Facilitators employed by local health services could support integrated approaches to enhancing the quality of primary care for this vulnerable population.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001970235 (retrospective).

Project description:BackgroundImproving oxygen systems may improve clinical outcomes for hospitalised children with acute lower respiratory infection (ALRI). This paper reports the effects of an improved oxygen system on mortality and clinical practices in 12 general, paediatric, and maternity hospitals in southwest Nigeria.Methods and findingsWe conducted an unblinded stepped-wedge cluster-randomised trial comparing three study periods: baseline (usual care), pulse oximetry introduction, and stepped introduction of a multifaceted oxygen system. We collected data from clinical records of all admitted neonates (<28 days old) and children (28 days to 14 years old). Primary analysis compared the full oxygen system period to the pulse oximetry period and evaluated odds of death for children, children with ALRI, neonates, and preterm neonates using mixed-effects logistic regression. Secondary analyses included the baseline period (enabling evaluation of pulse oximetry introduction) and evaluated mortality and practice outcomes on additional subgroups. Three hospitals received the oxygen system intervention at 4-month intervals. Primary analysis included 7,716 neonates and 17,143 children admitted during the 2-year stepped crossover period (November 2015 to October 2017). Compared to the pulse oximetry period, the full oxygen system had no association with death for children (adjusted odds ratio [aOR] 1.06; 95% confidence interval [CI] 0.77-1.46; p = 0.721) or children with ALRI (aOR 1.09; 95% CI 0.50-2.41; p = 0.824) and was associated with an increased risk of death for neonates overall (aOR 1.45; 95% CI 1.04-2.00; p = 0.026) but not preterm/low-birth-weight neonates (aOR 1.30; 95% CI 0.76-2.23; p = 0.366). Secondary analyses suggested that the introduction of pulse oximetry improved oxygen practices prior to implementation of the full oxygen system and was associated with lower odds of death for children with ALRI (aOR 0.33; 95% CI 0.12-0.92; p = 0.035) but not for children, preterm neonates, or neonates overall (aOR 0.97, 95% CI 0.60-1.58, p = 0.913; aOR 1.12, 95% CI 0.56-2.26, p = 0.762; aOR 0.90, 95% CI 0.57-1.43, p = 0.651). Limitations of our study are a lower-than-anticipated power to detect change in mortality outcomes (low event rates, low participant numbers, high intracluster correlation) and major contextual changes related to the 2016-2017 Nigerian economic recession that influenced care-seeking and hospital function during the study period, potentially confounding mortality outcomes.ConclusionsWe observed no mortality benefit for children and a possible higher risk of neonatal death following the introduction of a multifaceted oxygen system compared to introducing pulse oximetry alone. Where some oxygen is available, pulse oximetry may improve oxygen usage and clinical outcomes for children with ALRI.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12617000341325.

Project description:PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

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A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care.

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A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care.

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