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Hypertension Improvement Project (HIP): study protocol and implementation challenges.

ABSTRACT: Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.This paper describes the protocol of a nested 2 x 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.ClinicalTrials.gov identifier NCT00201136.

SUBMITTER: Dolor RJ

PROVIDER: S-EPMC2654882 | biostudies-literature | 2009 Feb

REPOSITORIES: biostudies-literature

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Hypertension Improvement Project (HIP): study protocol and implementation challenges.

Dolor Rowena J RJ Yancy William S WS Owen William F WF Matchar David B DB Samsa Gregory P GP Pollak Kathryn I KI Lin Pao-Hwa PH Ard Jamy D JD Prempeh Maxwell M McGuire Heather L HL Batch Bryan C BC Fan William W Svetkey Laura P LP

Trials 20090226

<h4>Background</h4>Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.<h4>Methods and design</h4>This paper describes the protocol of a nested 2 x 2 randomized controlled trial to t ...[more]

PMID: 19245692

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Project description:BACKGROUND:Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. METHODS:A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. DISCUSSION:Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

Project description:ObjectiveTo undertake a cost-effectiveness analysis of a Community-based Hypertension Improvement Project (ComHIP) compared with standard hypertension care in Ghana.DesignCost-effectiveness analysis using a Markov model.SettingLower Manya Krobo, Eastern Region, Ghana.InterventionWe evaluated ComHIP, an intervention with multiple components, including: community-based education on cardiovascular disease (CVD) risk factors and healthy lifestyles; community-based screening and monitoring of blood pressure by licensed chemical sellers and CVD nurses; community-based diagnosis, treatment, counselling, follow-up and referral of hypertension patients by CVD nurses; telemedicine consultation by CVD nurses and referral of patients with severe hypertension and/or organ damage to a physician; information and communication technologies messages for healthy lifestyles, treatment adherence support and treatment refill reminders for hypertension patients; Commcare, a cloud-based health records system linked to short-message service (SMS)/voice messaging for treatment adherence, reminders and health messaging. ComHIP was evaluated under two scale-up scenarios: (1) ComHIP as currently implemented with support from international partners and (2) ComHIP under full local implementation.Main outcome measuresIncremental cost per disability-adjusted life-year (DALY) averted from a societal perspective over a time horizon of 10 years.ResultsComHIP is unlikely to be a cost-effective intervention, with current ComHIP implementation and ComHIP under full local implementation costing on average US$12 189 and US$6530 per DALY averted, respectively. Results were robust to uncertainty analyses around model parameters.ConclusionsHigh overhead costs and high patient costs in ComHIP suggest that the societal costs of ensuring appropriate hypertension care are high and may not produce sufficient impact to achieve cost-effective implementation. However, these results are limited by the evidence quality of the effectiveness estimates, which comes from observational data rather than from randomised controlled study design.

Project description:IntroductionAmid the rising number of people with non-communicable diseases (NCDs), Kenya has invested in strengthening primary care and in efforts to expand existing service delivery platforms to integrate NCD care. One such approach is the AMPATH (Academic Model Providing Access to Healthcare) model in western Kenya, which provides the platform for the Primary Health Integrated Care Project for Chronic Conditions (PIC4C), launched in 2018 to further strengthen primary care services for the prevention and control of hypertension, diabetes, breast and cervical cancer. This study seeks to understand how well PIC4C delivers on its intended aims and to inform and support scale up of the PIC4C model for integrated care for people with NCDs in Kenya.Methods and analysisThe study is guided by a conceptual framework on implementing, sustaining and spreading innovation in health service delivery. We use a multimethod design combining qualitative and quantitative approaches, involving: (1) in-depth interviews with health workers and decision-makers to explore experiences of delivering PIC4C; (2) a cross-sectional survey of patients with diabetes or hypertension and in-depth interviews to understand how well PIC4C meets patients' needs; (3) a cohort study with an interrupted time series analysis to evaluate the degree to which PIC4C leads to health benefits such as improved management of hypertension or diabetes; and (4) a cohort study of households to examine the extent to which the national hospital insurance chronic care package provides financial risk protection to people with hypertension or diabetes within PIC4C.Ethics and disseminationThe study has received approvals from Moi University Institutional Research and Ethics Committee (FAN:0003586) and the London School of Hygiene & Tropical Medicine (17940). Workshops with key stakeholders at local, county, national and international levels will ensure early and wide dissemination of our findings to inform scale up of this model of care. We will also publish findings in peer-reviewed journals.

Project description:BackgroundPrimary immunodeficiencies (PIs) are a set of heterogeneous chronic disorders characterized by immune dysfunction. They are diagnostically challenging because of their clinical heterogeneity, knowledge gaps among primary care physicians, and continuing shortages of clinically trained immunologists. As a result, patients with undiagnosed PIs are at increased risk for recurrent infections, cancers, and autoimmune diseases.ObjectiveThe aim of this research is to develop and implement a clinical decision support (CDS) tool for the identification of underlying PIs.MethodsWe will develop and implement a CDS tool for the identification of underlying PIs among patients who receive primary care through a health care provider at the University of Iowa Hospitals and Clinics. The CDS tool will function through an algorithm that is based on the Immune Deficiency Foundation's 10 Warning Signs for Primary Immunodeficiency. Over the course of a year, we will use Lean Six Sigma principles and the Define, Measure, Analyze, Improve, and Control (DMAIC) framework to guide the project. The primary measure is the number of newly diagnosed PI patients per month. Secondary measures include the following: (1) the number of new patients identified by the CDS as being at high risk for PI, (2) the number of new PI cases in which immunoglobulin replacement or rotating antibiotics are started, (3) the cost of evaluation of each patient identified by the CDS tool as being at high risk for PIs, (4) the number of new consults not diagnosed with a PI, and (5) patient satisfaction with the process of referral to the Immunology Clinic.ResultsThis study was determined to not be Human Subjects Research by the Institutional Review Board at the University of Iowa. Data collection will begin in August 2021.ConclusionsThe development and implementation of a CDS tool is a promising approach to identifying patients with underlying PI. This protocol assesses whether such an approach will be able to achieve its objective of reducing diagnostic delays. The disciplined approach, using Lean Six Sigma and the DMAIC framework, will guide implementation to maximize opportunities for a successful intervention that meets the study's goals and objectives as well as to allow for replication and adaptation of these methods at other sites.International registered report identifier (irrid)PRR1-10.2196/32635.

Project description:IntroductionThe need for quantitative criteria to appraise the quality of implementation research has recently been highlighted to improve methodological rigour. The Implementation Science Research development (ImpRes) tool and supplementary guide provide methodological guidance and recommendations on how to design high-quality implementation research. This protocol reports on the development of the Implementation Science Research Project Appraisal Criteria (ImpResPAC) tool, a quantitative appraisal tool, developed based on the structure and content of the ImpRes tool and supplementary guide, to evaluate the conceptual and methodological quality of implementation research.Methods and analysisThis study employs a three-stage sequential mixed-methods design. During stage 1, the research team will map core domains of the ImpRes tool, guidance and recommendations contained in the supplementary guide and within the literature, to ImpResPAC. In stage 2, an international multidisciplinary expert group, recruited through purposive sampling, will inform the refinement of ImpResPAC, including content, scoring system and user instructions. In stage 3, an extensive psychometric evaluation of ImpResPAC, that was created in stage 1 and refined in stage 2, will be conducted. The scaling assumptions (inter-item and item-total correlations), reliability (internal consistency, inter-rater) and validity (construct and convergent validity) will be investigated by applying ImpResPAC to 50 protocols published in Implementation Science. We envisage developing ImpResPAC in this way will provide implementation research stakeholders, primarily grant reviewers and educators, a comprehensive, transparent and fair appraisal of the conceptual and methodological quality of implementation research, increasing the likelihood of funding research that will generate knowledge and contribute to the advancement of the field.Ethics and disseminationThis study will involve human participants. This study has been registered and minimal risk ethical clearance granted by The Research Ethics Office, King's College London (reference number MRA-20/21-20807). Participants will receive written information on the study via email and will provide e-consent if they wish to participate. We will use traditional academic modalities of dissemination (eg, conferences and publications).

Project description:INTRODUCTION:Bringing together continuous quality improvement (CQI) data from multiple health services offers opportunities to identify common improvement priorities and to develop interventions at various system levels to achieve large-scale improvement in care. An important principle of CQI is practitioner participation in interpreting data and planning evidence-based change. This study will contribute knowledge about engaging diverse stakeholders in collaborative and theoretically informed processes to identify and address priority evidence-practice gaps in care delivery. This paper describes a developmental evaluation to support and refine a novel interactive dissemination project using aggregated CQI data from Aboriginal and Torres Strait Islander primary healthcare centres in Australia. The project aims to effect multilevel system improvement in Aboriginal and Torres Strait Islander primary healthcare. METHODS AND ANALYSIS:Data will be gathered using document analysis, online surveys, interviews with participants and iterative analytical processes with the research team. These methods will enable real-time feedback to guide refinements to the design, reports, tools and processes as the interactive dissemination project is implemented. Qualitative data from interviews and surveys will be analysed and interpreted to provide in-depth understanding of factors that influence engagement and stakeholder perspectives about use of the aggregated data and generated improvement strategies. Sources of data will be triangulated to build up a comprehensive, contextualised perspective and integrated understanding of the project's development, implementation and findings. ETHICS AND DISSEMINATION:The Human Research Ethics Committee (HREC) of the Northern Territory Department of Health and Menzies School of Health Research (Project 2015-2329), the Central Australian HREC (Project 15-288) and the Charles Darwin University HREC (Project H15030) approved the study. Dissemination will include articles in peer-reviewed journals, policy and research briefs. Results will be presented at conferences and quality improvement network meetings. Researchers, clinicians, policymakers and managers developing evidence-based system and policy interventions should benefit from this research.

Project description:BackgroundMood-stabilizing medications are a cornerstone of treatment for people with bipolar disorder, though approximately half of these individuals are poorly adherent with their medication, leading to negative and even severe health consequences. While a variety of approaches can lead to some improvement in medication adherence, there is no single approach that has superior adherence enhancement and limited data on how these approaches can be implemented in clinical settings. Existing data have shown an increasing need for virtual delivery of care and interactive telemedicine interventions may be effective in improving adherence to long-term medication.MethodsCustomized adherence enhancement (CAE) is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention using a flexibly administered modular format that can be delivered via telehealth communications. CAE is comprised of up to four standard treatment modules including Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing. Participants will attend assigned module sessions with an interventionist based on their reasons for non-adherence and will be assessed for adherence, functioning, bipolar symptoms, and health resource use across a 12-month period. Qualitative and quantitative data will also be collected to assess barriers and facilitators to CAE implementation and reach and adoption of CAE among clinicians in the community.DiscussionThe proposed study addresses the need for practical adherence interventions that are effective, flexible, and designed to adapt to different settings and patients. By focusing on a high-risk, vulnerable group of people with bipolar disorder, and refining an evidence-based approach that will integrate into workflow of public-sector care and community mental health clinics, there is substantial potential for improving bipolar medication adherence and overall health outcomes on a broad level.Trial registrationThe study was registered on ClinicalTrials.gov NCT04622150 on November 9, 2020.

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Hypertension Improvement Project (HIP): study protocol and implementation challenges.

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Hypertension Improvement Project (HIP): study protocol and implementation challenges.

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