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Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care.

ABSTRACT: The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment.This will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose.The ease-of-use of this technique lead us to believe that self-management is feasible and will represent an innovative advance that should have a substantial impact on the quality of life of this patients and their families as well as on the health care provision systems.Osakidetza Protocol Record ISCIII-11/02285, Oral anticoagulation and self-management, ClinicalTrials.gov Identifier: NCT01878539.

SUBMITTER: Tamayo Aguirre E

PROVIDER: S-EPMC3765739 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care.

Tamayo Aguirre Eduardo E Vergara-Mitxeltorena Itziar I Uranga Saez Del Burgo Edurne E Ostiza-Irigoyen Aitziber A Garcia-Carro Alejandro A Lopez-Fernandez Isabel I Galo-Anza Arrate A

BMC cardiovascular disorders 20130822

<h4>Background</h4>The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The o ...[more]

PMID: 23968316

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Project description:BackgroundSelf-management may be an option to monitor oral anticoagulant therapy in health systems, but before recommending it, we need to assess patients' ability to take on this task. The purpose of the study was to describe patients' ability to self-manage and associated factors.MethodsThis was a 3-year prospective quasi-experimental study with a control group. Overall, 333 patients on anticoagulant therapy from seven primary care health centres of the Basque Health Service were included in the intervention group and followed up for 6 months after the intervention, assessing their ability to self-test and self-manage. The intervention consisted of a patient training programme, providing detailed information on their condition and its treatment, and practical training in how to use a portable blood coagulation monitor and adjust their anticoagulant dose. Comparisons were made with a control group (333 patients receiving OAT under usual care from the same seven health centres). Outcome variables were ability to self-manage, quality of the outcome (in terms of time in therapeutic range), and quality of life in the intervention group, and general patient characteristics (age and sex), clinical variables (reason for OAT, INR range), and quality of the outcome (in terms of percentage of INR measurements in range and complications) in both groups.ResultsOverall, 26.13 % of patients invited to participate in the intervention agreed. Of these, 99 % successfully learned to self-manage their OAT. Just 4.2 % did not complete the follow-up, in all cases for reasons unrelated to self-management, and 4.5 % required additional learning support. Outcomes were better than under usual care in terms of percentage of INR measurements in range (12 %), rate of complications (4 %) and quality of life (9.2 %).LimitationsPatients were only followed-up period for 6 months and the study was conducted in a single health organization. Though patients eligible to participate were selected randomly, they were not randomly allocated to the groups. This is a potential source of selection bias. Data needed to calculate in-range time were not collected from controls; rather the results for the self-management group were compared with external data from other studies.ConclusionsAlmost all participants achieved competency in self-management, with no differences by age, sex, concurrent illnesses, polypharmacy or educational level. The greatest barrier to self-management was the attitude of patients themselves and those around them. Self-management in primary care is a good alternative to usual care, patients having longer times in therapeutic range and fewer complications, and improving their quality of life. Remote management is a good support tool.Trial registrationClinicalTrials.gov Identifier: NCT01878539.

Project description:BackgroundThe introduction of point-of-care devices for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can either adjust their medication according to a pre-determined dose-INR (international normalized ratio) schedule (self-management), or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Increasing evidence suggests self-testing of oral anticoagulant therapy is equal to or better than standard monitoring. This is an updated version of the original review published in 2010.ObjectivesTo evaluate the effects on thrombotic events, major haemorrhages, and all-cause mortality of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring.Search methodsFor this review update, we re-ran the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 6, the Cochrane Library, MEDLINE (Ovid, 1946 to June week 4 2015), Embase (Ovid, 1980 to 2015 week 27) on 1 July 2015. We checked bibliographies and contacted manufacturers and authors of relevant studies. We did not apply any language restrictions .Selection criteriaOutcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management.Data collection and analysisReview authors independently extracted data and we used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto's method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics and used GRADE methodology to assess the quality of evidence.Main resultsWe identified 28 randomised trials including 8950 participants (newly incorporated in this update: 10 trials including 4227 participants). The overall quality of the evidence was generally low to moderate. Pooled estimates showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0.75; participants = 7594; studies = 18; moderate quality of evidence). Both, trials of self-management or self-monitoring showed reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70; participants = 3497; studies = 11) and (RR 0.69, 95% CI 0.49 to 0.97; participants = 4097; studies = 7), respectively; the quality of evidence for both interventions was moderate. No reduction in all-cause mortality was found (RR 0.85, 95% CI 0.71 to 1.01; participants = 6358; studies = 11; moderate quality of evidence). While self-management caused a reduction in all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84; participants = 3058; studies = 8); self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15; participants = 3300; studies = 3); the quality of evidence for both interventions was moderate. In 20 trials (8018 participants) self-monitoring or self-management did not reduce major haemorrhage (RR 0.95, 95% CI, 0.80 to 1.12; moderate quality of evidence). There was no significant difference found for minor haemorrhage (RR 0.97, 95% CI 0.67 to 1.41; participants = 5365; studies = 13). The quality of evidence was graded as low because of serious risk of bias and substantial heterogeneity (I(2) = 82%).Authors' conclusionsParticipants who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. Thromboembolic events were reduced, for both those self-monitoring or self-managing oral anticoagulation therapy. A reduction in all-cause mortality was observed in trials of self-management but not in self-monitoring, with no effects on major haemorrhage.

Project description:BackgroundThe health burden of type 2 diabetes can be mitigated by engaging patients in two key aspects of diabetes care: self-management and regular contact with health professionals. There is a clear benefit to integrating these aspects of care into a single clinical tool, and as mobile phone ownership increases, apps become a more feasible platform. However, the effectiveness of online health interventions is contingent on uptake by health care providers, which is typically low. There has been little research that focuses specifically on barriers and facilitators to health care provider uptake for interventions that link self-management apps to the user's primary care physician (PCP).ObjectiveThis study aimed to explore PCP perspectives on proposed features for a self-management app for patients with diabetes that would link to primary care services.MethodsResearchers conducted 25 semistructured interviews. The interviewer discussed potential features that would link in with the patient's primary care services. Interviews were audio-recorded, transcribed, and coded. Framework analysis and the Consolidated Criteria for Reporting Qualitative Research checklist were employed to ensure rigor.ResultsOur analysis indicated that PCP attitudes toward proposed features for an app were underpinned by perceived roles of (1) diabetes self-management, (2) face-to-face care, and (3) the anticipated burden of new technologies on their practice. Theme 1 explored PCP perceptions about how an app could foster patient independence for self-management behaviors but could also increase responsibility and liability for the PCP. Theme 2 identified beliefs underpinning a commonly expressed preference for face-to-face care. PCPs perceived information was more motivating, better understood, and presented with greater empathy when delivered face to face rather than online. Theme 3 described how most PCPs anticipated an initial increase in workload while they learned to use a new clinical tool. Some PCPs accepted this burden on the basis that the change was inevitable as health care became more integrated. Others reported potential benefits were outweighed by effort to implement an app. This study also identified how app features can be positively framed, highlighting potential benefits for PCPs to maximize PCP engagement, buy-in, and uptake. For example, PCPs were more positive when they perceived that an app could facilitate communication and motivation between consultations, focus on building capacity for patient independence, and reinforce rather than replace in-person care. They were also more positive about app features that were automated, integrated with existing software, flexible for different patients, and included secondary benefits such as improved documentation.ConclusionsThis study provided insight into PCP perspectives on a diabetes app integrated with primary care services. This was observed as more than a technological change; PCPs were concerned about changes in workload, their role in self-management, and the nature of consultations. Our research highlighted potential facilitators and barriers to engaging PCPs in the implementation process.

Project description:BackgroundStructured self-management education (SSME) for people with type 2 diabetes mellitus (T2DM) improves biomedical and psychological outcomes, whilst being cost-effective. Yet uptake in the UK remains low. An 'Embedding Package' addressing barriers and enablers to uptake at patient, health care professional and organisational levels has been developed. The aim of this study was to test the feasibility of conducting a subsequent randomised controlled trial (RCT) to evaluate the Embedding Package in primary care, using a mixed methods approach.MethodsA concurrent mixed methods approach was adopted. Six general practices in the UK were recruited and received the intervention (the Embedding Package). Pseudonymised demographic, biomedical and SSME data were extracted from primary care medical records for patients recorded as having a diagnosis of T2DM. Descriptive statistics assessed quantitative data completeness and accuracy. Quantitative data were supplemented and validated by a patient questionnaire, for which two recruitment methods were trialled. Where consent was given, the questionnaire and primary care data were linked and compared. The cost of the intervention was estimated. An integrated qualitative study comprising ethnography and stakeholder and patient interviews explored the process of implementation, sustainability of change and 'fit' of the intervention. Qualitative data were analysed using a thematic framework guided by the Normalisation Process Theory (NPT).ResultsPrimary care data were extracted for 2877 patients. The primary outcome for the RCT, HbA1c, was over 90% complete. Questionnaires were received from 423 (14.7%) participants, with postal invitations yielding more participants than general practitioner (GP) prompts. Ninety-one percent of questionnaire participants consented to data linkage. The mean cost per patient for the Embedding Package was £8.94, over a median follow-up of 162.5?days. Removing the development cost, this reduces to £5.47 per patient. Adoption of ethnographic and interview methods in the collection of data was appropriate, and the use of NPT, whilst challenging, enhanced the understanding of the implementation process. The need to delay the collection of patient interview data to enable the intervention to inform patient care was highlighted.ConclusionsIt is feasible to collect data with reasonable completeness and accuracy for the subsequent RCT, although refinement to improve the quality of the data collected will be undertaken. Based on resource use data collected, it was feasible to produce cost estimates for each individual component of the Embedding Package. The methods chosen to generate, collect and analyse qualitative data were satisfactory, keeping participant burden low and providing insight into potential refinements of the Embedding Package and customisation of the methods for the RCT.Trial registrationISRCTN, ISRCTN21321635, Registered 07/07/2017-retrospectively registered.

Dataset Information

Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care.

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Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care.

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