Evidence map›Paper›PMID 21477372›Full record

Trial reportBMC family practice2011

Practice nursed-based, individual and video-assisted patient education in oral anticoagulation--protocol of a cluster-randomized controlled trial.

Thanh Duc Hua, Stefan Viktor Vormfelde, Manar Abu Abed, Hannelore Schneider-Rudt, Petra Sobotta, Tim Friede, Jean-François Chenot

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC family practice, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Thanh Duc HuaDepartment of General Practice, University Medical Centre Göttingen, Humboldtallee 38, Göttingen, 37073, Germany. thanhduc.hua@med.uni-goettingen.de
Stefan Viktor Vormfelde
Manar Abu Abed
Hannelore Schneider-Rudt
Petra Sobotta
Tim Friede
Jean-François Chenot

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManaging oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only. METHODS AND

designThis trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range. DISCUSSION: This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we expect to discover differences in secondary outcomes, such as the time spent in the therapeutic range.

trial registrationDeutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586Universal Trial Number (UTN U1111-1118-3464).

Indexed as

Administration, OralAnticoagulantsAtrial FibrillationClinical ProtocolsCluster AnalysisGeneral PracticeHumansMedication AdherenceNursesPamphletsPatient CompliancePatient Education as TopicPhenprocoumonPrimary Health CareProgram DevelopmentSurveys and QuestionnairesAnticoagulantsPhenprocoumon

Identifiers

PMID21477372
PMCPMC3089775

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.