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Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial.

ABSTRACT: Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme was initiated in Denmark, and during a 3-year period all practices, as default, should undergo accreditation according to the Danish Healthcare Quality Program. The aim of this study is primarily to evaluate the effects of a mandatory accreditation scheme.The study is conducted as a cluster-randomized controlled trial among 1252 practices (clusters) with 2211 general practitioners in Denmark. Practices allocated to accreditation in 2016 serve as the intervention group, and practices allocated to accreditation in 2018 serve as controls. The selected outcomes should meet the following criteria: (1) a high degree of clinical relevance; (2) the possibility to assess changes due to accreditation; (3) availability of data from registers with no self-reporting data. The primary outcome is the number of prescribed drugs in patients older than 65 years. Secondary outcomes are changes in outcomes related to other perspectives of safe medication, good clinical practice and mortality. All outcomes relate to quality indicators included in the Danish Healthcare Quality Program, which is based on general principles for accreditation.The consequences of accreditation and standard-setting processes are generally under-researched, particularly in general practice. This is the largest study in general practice with a randomized implementation approach to evaluate the clinical effects of a nation-wide mandatory accreditation scheme in general practice.ClinicalTrials.gov, NCT02762240 . Registered on 24 May 2016.

SUBMITTER: Andersen MK

PROVIDER: S-EPMC5307771 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial.

Andersen Merethe K MK Pedersen Line B LB Siersma Volkert V Bro Flemming F Reventlow Susanne S Søndergaard Jens J Kousgaard Marius Brostrøm MB Waldorff Frans B FB

Trials 20170213 1

<h4>Background</h4>Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme was initiated in Denmark, and during a 3-year period all practices, as default, should undergo accreditation according to the Danish Healthcare Quality Program. The aim of this study is primarily to evaluate the effects of a mandatory accreditation scheme.<h4>Methods/desi ...[more]

PMID: 28193288

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Project description:IntroductionManaging patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT.Methods and analysisThis pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted.Ethics and disseminationThis trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences.Trial registration numberISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

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Project description:Individuals of African descent living in western countries have increased rates of hypertension and hypertension-related complications. Poor adherence to hypertension treatment (medication and lifestyle changes) has been identified as one of the most important modifiable causes for the observed disparities in hypertension related complications, with patient education being recommended to improve adherence. Despite evidence that culturally-appropriate patient education may improve the overall quality of care for ethnic minority patients, few studies have focused on how hypertensive individuals of African descent respond to this approach. This paper describes the design of a study that compares the effectiveness of culturally-appropriate hypertension education with that of the standard approach among Surinamese and Ghanaian hypertensive patients with an elevated blood pressure in Dutch primary care practices.A cluster-randomized controlled trial will be conducted in four primary care practices in Amsterdam, all offering hypertension care according to Dutch clinical guidelines. After randomization, patients in the usual care sites (n = 2) will receive standard hypertension education. Patients in the intervention sites (n = 2) will receive three culturally-appropriate hypertension education sessions, culturally-specific educational materials and targeted lifestyle support. The primary outcome will be the proportion of patients with a reduction in systolic blood pressure >or= 10 mmHg at eight months after the start of the trial. The secondary outcomes will be the proportion of patients with self-reported adherence to (i) medication and (ii) lifestyle recommendations at eight months after the start of the trial. The study will enrol 148 patients (74 per condition, 37 per site). Eligibility criteria for patients of either sex will be: current diagnosis of hypertension, self-identified Afro-Surinamese or Ghanaian, >or= 20 years, and baseline blood pressure >or= 140/90 mmHg. Primary and secondary outcomes will be measured at baseline and at 3 1/2, 6 1/2, and eight months. Other measurements will be performed at baseline and eight months.The findings will provide new knowledge on how to improve blood pressure control and patient adherence in ethnic minority persons with a high risk of negative hypertension-related health outcomes.ISRCTN35675524.

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Dataset Information

Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial.

Publications

Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial.

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