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A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

ABSTRACT: BACKGROUND:Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention. METHODS:A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS. DISCUSSION:This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation. TRIAL REGISTRATION:Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.

SUBMITTER: Dickinson WP

PROVIDER: S-EPMC6058364 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

Dickinson W Perry WP Dickinson L Miriam LM Jortberg Bonnie T BT Hessler Danielle M DM Fernald Douglas H DH Fisher Lawrence L

BMC family practice 20180724 1

<h4>Background</h4>Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clin ...[more]

PMID: 30041598

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Project description:BackgroundPrimary health professionals are well positioned to support the delivery of patient self-management in an evidence-based, structured capacity. A need exists to better understand the active components required for effective self-management support, how these might be delivered within primary care, and the training and system changes that would subsequently be needed.Objectives(1) To examine self-management support interventions in primary care on health outcomes for a wide range of diseases compared to usual standard of care; and (2) To identify the effective strategies that facilitate positive clinical and humanistic outcomes in this setting.MethodA systematic review of randomized controlled trials evaluating self-management support interventions was conducted following the Cochrane handbook & PRISMA guidelines. Published literature was systematically searched from inception to June 2019 in PubMed, Scopus and Web of Science. Eligible studies assessed the effectiveness of individualized interventions with follow-up, delivered face-to-face to adult patients with any condition in primary care, compared with usual standard of care. Matrices were developed that mapped the evidence and components for each intervention. The methodological quality of included studies were appraised.Results6,510 records were retrieved. 58 studies were included in the final qualitative synthesis. Findings reveal a structured patient-provider exchange is required in primary care (including a one-on-one patient-provider consultation, ongoing follow up and provision of self-help materials). Interventions should be tailored to patient needs and may include combinations of strategies to improve a patient's disease or treatment knowledge; independent monitoring of symptoms, encouraging self-treatment through a personalized action plan in response worsening symptoms or exacerbations, psychological coping and stress management strategies, and enhancing responsibility in medication adherence and lifestyle choices. Follow-up may include tailored feedback, monitoring of progress with respect to patient set healthcare goals, or honing problem-solving and decision-making skills. Theoretical models provided a strong base for effective SMS interventions. Positive outcomes for effective SMS included improvements in clinical indicators, health-related quality of life, self-efficacy (confidence to self-manage), disease knowledge or control. An SMS model has been developed which sets the foundation for the design and evaluation of practical strategies for the construct of self-management support interventions in primary healthcare practice.ConclusionsThese findings provide primary care professionals with evidence-based strategies and structure to deliver SMS in practice. For this collaborative partnership approach to be more widely applied, future research should build on these findings for optimal SMS service design and upskilling healthcare providers to effectively support patients in this collaborative process.

Project description:ObjectiveTo determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care.DesignPragmatic, two arm, cluster randomised controlled trial.SettingGeneral practices, serving a population in northwest England with high levels of deprivation.Participants5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices).InterventionPractice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation.Main outcome measuresPrimary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement.ResultsWe randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference.ConclusionsAn intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients' everyday lives.Trial registrationCurrent Controlled Trials ISRCTN90940049.

Project description:INTRODUCTION:The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. ETHICS AND DISSEMINATION:Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT02696187.

Project description:IntroductionThe use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context.Methods and analysisThe overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled through advertisment or by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessment, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up.Ethics and disseminationEthical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274 and dnr 2019-05572. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations.Trial registration numberNCT03746873.

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A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

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A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

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