Effectiveness of improvement plans in primary care practice accreditation: a clustered randomized trial.
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ABSTRACT: Background
Accreditation of healthcare organizations is a widely used method to assess and improve quality of healthcare. Our aim was to determine the effectiveness of improvement plans in practice accreditation of primary care practices, focusing on cardiovascular risk management (CVRM).Method
A two-arm cluster randomized controlled trial with a block design was conducted with measurements at baseline and follow-up. Primary care practices allocated to the intervention group (n?=?22) were instructed to focus improvement plans during the intervention period on CVRM, while practices in the control group (n?=?23) could focus on any domain except on CVRM and diabetes mellitus. Primary outcomes were systolic blood pressure <140 mmHg, LDL cholesterol <2.5 mmol/l and prescription of antiplatelet drugs. Secondary outcomes were 17 indicators of CVRM and physician's perceived goal attainment for the chosen improvement project.Results
No effect was found on the primary outcomes. Blood pressure targets were reached in 39.8% of patients in the intervention and 38.7% of patients in the control group; cholesterol target levels were reached in 44.5% and 49.0% respectively; antiplatelet drugs were prescribed in 82.7% in both groups. Six secondary outcomes improved: smoking status, exercise control, diet control, registration of alcohol intake, measurement of waist circumference, and fasting glucose. Participants' perceived goal attainment was high in both arms: mean scores of 7.9 and 8.2 on the 10-point scale.Conclusions
The focus of improvement plans on CVRM in the practice accreditation program led to some improvements of CVRM, but not on the primary outcomes. ClinicalTrials.gov NCT00791362.
SUBMITTER: Nouwens E
PROVIDER: S-EPMC4252098 | biostudies-literature | 2014
REPOSITORIES: biostudies-literature
Publications
Effectiveness of improvement plans in primary care practice accreditation: a clustered randomized trial.
Nouwens Elvira E van Lieshout Jan J Bouma Margriet M Braspenning Jozé J Wensing Michel M
PloS one 20141202 12
<h4>Background</h4>Accreditation of healthcare organizations is a widely used method to assess and improve quality of healthcare. Our aim was to determine the effectiveness of improvement plans in practice accreditation of primary care practices, focusing on cardiovascular risk management (CVRM).<h4>Method</h4>A two-arm cluster randomized controlled trial with a block design was conducted with measurements at baseline and follow-up. Primary care practices allocated to the intervention group (n = ...[more]
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Project description:BackgroundCardiovascular risk management is largely provided in primary healthcare, but not all patients with established cardiovascular diseases receive preventive treatment as recommended. Accreditation of healthcare organizations has been introduced across the world with a range of aims, including the improvement of clinical processes and outcomes. The Dutch College of General Practitioners has launched a program for accreditation of primary care practices, which focuses on chronic illness care. This study aims to determine the effectiveness and efficiency of a practice accreditation program, focusing on patients with established cardiovascular diseases.Methods/designWe have planned a two-arm cluster randomized trial with a block design. Seventy primary care practices will be recruited from those who volunteer to participate in the practice accreditation program. Primary care practices will be the unit of randomization. A computer list of random numbers will be generated by an independent statistician. The intervention group (n = 35 practices) will be instructed to focus improvement on cardiovascular risk management. The control group will be instructed to focus improvement on other domains in the first year of the program. Baseline and follow-up measurements at 12 months after receiving the accreditation certificate are based on a standardized version of the audit in the practice accreditation program. Primary outcomes include controlled blood pressure, serum cholesterol, and prescription of recommended preventive medication. Secondary outcomes are 15 process indicators and two outcome indicators of cardiovascular risk management, self-reported achievement of improvement goals and perceived unintended consequences. The intention to treat analysis is statistically powered to detect a difference of 10% on primary outcomes. The economic evaluation aims to determine the efficiency of the program and investigates the relationship between costs, performance indicators, and accreditation.DiscussionIt is important to gain more information about the effectiveness and efficiency of the practice accreditation program to assess if participation is worthwhile regarding the quality of cardiovascular risk management. The results of this study will help to develop the practice accreditation program for primary care practices.
| S-EPMC3533965 | biostudies-literature
Project description:BackgroundDepression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care.MethodsCost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months.ResultsWith a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results.ConclusionsCompared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated.Trial registrationClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.
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Project description:OBJECTIVE:To evaluate a distance-learning, quality improvement intervention to improve pediatric primary care provider use of attention-deficit/hyperactivity disorder (ADHD) rating scales. METHODS:Primary care practices were cluster randomized to a 3-part distance-learning, quality improvement intervention (web-based education, collaborative consultation with ADHD experts, and performance feedback reports/calls), qualifying for Maintenance of Certification (MOC) Part IV credit, or wait-list control. We compared changes relative to a baseline period in rating scale use by study arm using logistic regression clustered by practice (primary analysis) and examined effect modification by level of clinician participation. An electronic health record-linked system for gathering ADHD rating scales from parents and teachers was implemented before the intervention period at all sites. Rating scale use was ascertained by manual chart review. RESULTS:One hundred five clinicians at 19 sites participated. Differences between arms were not significant. From the baseline to intervention period and after implementation of the electronic system, clinicians in both study arms were significantly more likely to administer and receive parent and teacher rating scales. Among intervention clinicians, those who participated in at least 1 feedback call or qualified for MOC credit were more likely to give parents rating scales with differences of 14.2 (95% confidence interval [CI], 0.6-27.7) and 18.8 (95% CI, 1.9-35.7) percentage points, respectively. CONCLUSION:A 3-part clinician-focused distance-learning, quality improvement intervention did not improve rating scale use. Complementary strategies that support workflows and more fully engage clinicians may be needed to bolster care. Electronic systems that gather rating scales may help achieve this goal. Index terms: ADHD, primary care, quality improvement, clinical decision support.
| S-EPMC5657444 | biostudies-literature
Project description:BACKGROUND: Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low. METHOD/DESIGN: This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. DISCUSSION: There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive. TRIAL REGISTRATION: ISRCTN: ISRCTN83365316.
| S-EPMC3283530 | biostudies-literature
Project description:BackgroundPractice facilitation has proven to be effective at improving care delivery. Practice facilitators are healthcare professionals who work with and support other healthcare providers. To the best of our knowledge, very few studies have explored the perspective of facilitators. The objective of this study was to gain insight into the barriers that facilitators face during the facilitation process and to identify approaches used to overcome these barriers to help practices move towards positive change.MethodsWe conducted semi-structured interviews with four practice facilitators who worked with 84 primary care practices in Eastern Ontario, Canada over a period of five years (2007-2012). The transcripts were analyzed independently by three members of the research team using an open coding technique. A qualitative data analysis using immersion/crystallization technique was applied to interpret the interview transcripts.ResultsCommon barriers identified by the facilitators included accessibility to the practice (e.g., difficulty scheduling meetings, short meetings), organizational behaviour (team organization, team conflicts, etc.), challenges with practice engagement (e.g., lack of interest, lack of trust), resistance to change, and competing priorities. To help practices move towards positive change the facilitators had to tailor their approach, integrate themselves, be persistent with practices, and exhibit flexibility.ConclusionsThe consensus on redesigning and transforming primary care in North America and around the world is rapidly growing. Practice facilitation has been pivotal in materializing the transformation in the way primary care practices deliver care. This study provides an exclusive insight into facilitator approaches which will assist the design and implementation of small- and large-scale facilitation interventions.
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Project description:Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets.A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The 'usual feedback' arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed.Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes.Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention.ClinicalTrials.gov NCT00996645.
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Project description:BACKGROUND:Primary care is the main treatment setting for panic disorder and should be supplemented by collaborative care programs. However, shortage of mental health professionals prevents collaborative care programs from being effectively implemented. The PARADISE study showed the efficacy of a self-managed, cognitive-behavioural therapy (CBT)-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the family practice team. OBJECTIVE:To assess the cost-effectiveness of the PARADISE intervention. DESIGN:Cost-effectiveness analysis from the societal perspective based on data from a cluster-randomized controlled trial over a time horizon of 12 months. PARTICIPANTS:Four hundred nineteen adult panic disorder patients with or without agoraphobia. INTERVENTIONS:A self-managed, CBT-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the primary care practice team in comparison to routine care. MAIN MEASURES:Total costs from the societal perspective. Direct costs and disease-specific costs. Quality-adjusted life years based on the EQ-5D-3L. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. KEY RESULTS:Patients in the intervention group caused lower costs (mean, €1017; 95% confidence interval [-€3306; €1272]; p?=?0.38) and gained on average more QALY (mean, 0.034 QALY (95% confidence interval [0.005; 0.062]; p?=?0.02). Therefore, the intervention dominated the control treatment. The probability of cost-effectiveness of the intervention at a willingness-to-pay margin of €50,000 per QALY was 96%. Results from supplementary analyses considering direct or disease-specific costs instead of total costs showed comparable results. CONCLUSION:The PARADISE intervention is cost effective. This conclusion is valid for total costs, generic health care (direct) costs, disease-specific health care costs. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004386 Current Controlled Trials: ISRCTN64669297.
| S-EPMC7174430 | biostudies-literature
Project description:Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices.We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss.Of the 390 participants, 86% completed the 2-year trial, at which time, the mean (±SE) weight loss with usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively. Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively. Enhanced lifestyle counseling was superior to usual care on both these measures of success (P=0.003 and P=0.02, respectively), with no other significant differences among the groups. The benefits of enhanced lifestyle counseling remained even after participants given sibutramine were excluded from the analyses. There were no significant differences between the intervention groups in the occurrence of serious adverse events.Enhanced weight-loss counseling helps about one third of obese patients achieve long-term, clinically meaningful weight loss. (Funded by the National Heart, Lung, and Blood Institute; POWER-UP ClinicalTrials.gov number, NCT00826774.).
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Project description:BACKGROUND:Symptoms account for more than 400 million clinic visits annually in the USA. The SPADE symptoms (sleep, pain, anxiety, depression, and low energy/fatigue) are particularly prevalent and undertreated. OBJECTIVE:To assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes. DESIGN:Randomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system. PARTICIPANTS:Primary care patients who screened positive for at least one SPADE symptom. INTERVENTIONS:After completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomized to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians. MAIN MEASURES:The primary outcome was the 3-month change in composite SPADE score. Secondary outcomes were individual symptom scores, symptom documentation in the clinic note, symptom-specific clinician actions, and patient satisfaction. KEY RESULTS:Most patients (84%) had multiple clinically significant (T-score???55) SPADE symptoms. Both groups demonstrated moderate symptom improvement with a non-significant trend favoring the feedback compared to control group (between-group difference in composite T-score improvement, 1.1; P?=?0.17). Symptoms present at baseline resolved at 3-month follow-up only one third of the time, and patients frequently still desired treatment. Except for pain, clinically significant symptoms were documented less than half the time. Neither symptom documentation, symptom-specific clinician actions, nor patient satisfaction differed between treatment arms. Predictors of greater symptom improvement included female sex, black race, fewer medical conditions, and receiving care in a family medicine clinic. CONCLUSIONS:Simple feedback of symptom scores to primary care clinicians in the absence of additional systems support or incentives is not superior to usual care in improving symptom outcomes. TRIAL REGISTRATION:clinicaltrials.gov identifier: NCT02383862.
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Project description:Importance:Dementia care management (DCM) can increase the quality of care for people with dementia. Methodologically rigorous clinical trials on DCM are lacking. Objective:To test the effectiveness and safety of DCM in the treatment and care of people with dementia living at home and caregiver burden (when available). Design, Setting, and Participants:This pragmatic, general practitioner-based, cluster-randomized intervention trial compared the intervention with care as usual at baseline and at 12-month follow-up. Simple 1:1 randomization of general practices in Germany was used. Analyses were intent to treat and per protocol. In total, 6838 patients were screened for dementia (eligibility: 70 years and older and living at home) from January 1, 2012, to March 31, 2016. Overall, 1167 (17.1%) were diagnosed as having dementia, and 634 (9.3%) provided written informed consent to participate. Interventions:Dementia care management was provided for 6 months at the homes of patients with dementia. Dementia care management is a model of collaborative care, defined as a complex intervention aiming to provide optimal treatment and care for patients with dementia and support caregivers using a computer-assisted assessment determining a personalized array of intervention modules and subsequent success monitoring. Dementia care management was targeted at the individual patient level and was conducted by 6 study nurses with dementia care-specific qualifications. Main Outcomes and Measures:Quality of life, caregiver burden, behavioral and psychological symptoms of dementia, pharmacotherapy with antidementia drugs, and use of potentially inappropriate medication. Results:The mean age of 634 patients was 80 years. A total of 407 patients received the intended treatment and were available for primary outcome measurement. Of these patients, 248 (60.9%) were women, and 204 (50.1%) lived alone. Dementia care management significantly decreased behavioral and psychological symptoms of dementia (b?=?-7.45; 95% CI, -11.08 to -3.81; P?<?.001) and caregiver burden (b?=?-0.50; 95% CI, -1.09 to 0.08; P?=?.045) compared with care as usual. Patients with dementia receiving DCM had an increased chance of receiving antidementia drug treatment (DCM, 114 of 291 [39.2%] vs care as usual, 31 of 116 [26.7%]) after 12 months (odds ratio, 1.97; 95% CI, 0.99 to 3.94; P?=?.03). Dementia care management significantly increased quality of life (b?=?0.08; 95% CI, 0 to 0.17; P?=?.03) for patients not living alone but did not increase quality of life overall. There was no effect on potentially inappropriate medication (odds ratio, 1.86; 95% CI, 0.62 to 3.62; P?=?.97). Conclusions and Relevance:Dementia care management provided by specifically trained nurses is an effective collaborative care model that improves relevant patient- and caregiver-related outcomes in dementia. Implementing DCM in different health care systems should become an active area of research. Trial Registration:clinicaltrials.gov Identifier: NCT01401582.
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