Prevention of post-splenectomy sepsis in patients with asplenia - a study protocol of a controlled trial.
Follow-Up Studies
Germany
/ epidemiology
Guideline Adherence
Health Communication
/ methods
Heterotaxy Syndrome
/ complications
Humans
Incidence
Motivation
Patient Compliance
Patient Education as Topic
Physicians
Postoperative Complications
/ prevention & control
Prospective Studies
Self Efficacy
Sepsis
/ epidemiology
Splenectomy
/ adverse effects
Telemedicine
/ methods
Telephone
Vaccination
/ methods
Asplenia
HAPA
Overwhelming post-splenectomy infection
Post-splenectomy sepsis
Prevention
Sepsis
Splenectomy
Telephone intervention
Vaccination
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
14 Jan 2020
14 Jan 2020
Historique:
received:
12
11
2019
accepted:
30
12
2019
entrez:
16
1
2020
pubmed:
16
1
2020
medline:
9
4
2020
Statut:
epublish
Résumé
Patients with asplenia have a significantly increased lifelong risk of severe invasive infections, particular post-splenectomy sepsis (PSS). Clear preventive measures have been described in the literature, but previous studies found poor implementation of prevention recommendations. Aim of the study is to improve the adherence to guideline-based preventive measures and thereby reduce the incidence of PSS by a novel telephone-delivered intervention that involves both patients and their physicians. A prospective controlled, two-armed historical control group design is used to evaluate the new intervention compared to usual care. The intervention for patients includes both educational aspects and, building on the Health Action Process Approach (HAPA), intervention components that promote motivation and planning of preventive measures. For physicians the intervention is primarily information-based. The primary outcome, the adherence to preventative measures, is indicated by a study-specific 'Preventing PSS-score' (PrePSS-score), which is assessed at baseline and at 6-months follow-up. Secondary outcomes include, amongst others, patient self-efficacy and action-planning, asplenia-specific health literacy, general self-management and asplenia-specific self-management. In a process-evaluating part of the study interview-data on patients' and physicians' evaluation of the intervention will be gathered. This trial will provide evidence about the effectiveness of the novel prevention intervention for asplenic patients. If demonstrated beneficial, the intervention manual will be made publicly available to enable implementation in practice. The experience gained within this trial may also be valuable for prevention strategies in patients with other diseases. German Clinical Trials Register (DRKS): DRKS00015238; Trial registration date 07. December 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Patients with asplenia have a significantly increased lifelong risk of severe invasive infections, particular post-splenectomy sepsis (PSS). Clear preventive measures have been described in the literature, but previous studies found poor implementation of prevention recommendations. Aim of the study is to improve the adherence to guideline-based preventive measures and thereby reduce the incidence of PSS by a novel telephone-delivered intervention that involves both patients and their physicians.
METHODS
METHODS
A prospective controlled, two-armed historical control group design is used to evaluate the new intervention compared to usual care. The intervention for patients includes both educational aspects and, building on the Health Action Process Approach (HAPA), intervention components that promote motivation and planning of preventive measures. For physicians the intervention is primarily information-based. The primary outcome, the adherence to preventative measures, is indicated by a study-specific 'Preventing PSS-score' (PrePSS-score), which is assessed at baseline and at 6-months follow-up. Secondary outcomes include, amongst others, patient self-efficacy and action-planning, asplenia-specific health literacy, general self-management and asplenia-specific self-management. In a process-evaluating part of the study interview-data on patients' and physicians' evaluation of the intervention will be gathered.
DISCUSSION
CONCLUSIONS
This trial will provide evidence about the effectiveness of the novel prevention intervention for asplenic patients. If demonstrated beneficial, the intervention manual will be made publicly available to enable implementation in practice. The experience gained within this trial may also be valuable for prevention strategies in patients with other diseases.
TRIAL REGISTRATION
BACKGROUND
German Clinical Trials Register (DRKS): DRKS00015238; Trial registration date 07. December 2018.
Identifiants
pubmed: 31937251
doi: 10.1186/s12879-019-4752-2
pii: 10.1186/s12879-019-4752-2
pmc: PMC6961276
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
41Subventions
Organisme : Innovationsausschuss of the Gemeinsamer Bundesausschuss
ID : 01VSF17049
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