PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
12. november 2014 oppdatert av: Radboud University Medical Center
Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
The main objective of the proposed study is to assess the effectiveness, feasibility and costs of a tailored strategy (developed in accordance with the barriers found and current practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a common strategy of 'audit & feedback'.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In a previous study among 22 Dutch hospitals many gaps in the care for patients with non-Hodgkin's lymphomas (NHL) were found, compared to best evidence as described in guidelines. In a problem analysis study, barriers and facilitators for good quality of NHL-care were assessed and a tailored implementation strategy was developed, based on these findings. The proposed study aims at the effectiveness, feasibility and costs of this tailored strategy to improve quality of care for patients with an NHL in a clustered randomized controlled trial in 19 Dutch hospitals.
Multilevel regression analyses will be performed to evaluate the effectiveness of both strategies. Exposure to and experiences with the strategy elements will be analysed descriptively.
Regarding the costs, the two strategies are compared with a health care perspective. The input of resources will be assessed by collecting volumes of consumed resources and multiplying these by the price of each resource unit; the implementation process and consequently costs will be estimated by an Activity Based Costing (ABC) approach. The output will be determined by the level of adherence to the NHL quality indicators.
Studietype
Intervensjonell
Registrering (Forventet)
418
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Gelderland
-
Nijmegen, Gelderland, Nederland, 6500 HB
- Radboud University Nijmegen Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of non-Hodgkin lymphoma
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard implementation strategy
Standard intervention
|
Standard intervention consists of audit&feedback
|
|
Eksperimentell: Innovative implementation strategy
Implementation tools
|
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in adherence to quality indicators for NHL care
Tidsramme: baseline and 1 year
|
The effect of our interventions will be measured by means of adherence to quality indicators for optimal NHL care.
The effects of the audit and feedback strategy (9 hospitals) versus the tailored strategy (9 hospitals) will be evaluated using previously developed quality indicators.
These indicators for optimal NHL care were developed on the basis of evidence based guidelines, literature and opinions of clinicians about NHL care in a previous study and were validated.
|
baseline and 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exposure to and experiences with the interventions
Tidsramme: after 1 year
|
To study the feasibility of both strategies, a process evaluation has to give insight into the mechanisms and processes responsible for the result (= extent of adherence to the indicator set for optimal NHL care).
The actual 'exposure' of the patients and professionals to the implementation elements, together with their experience with these elements may have influenced the final result (success or failure of adherence).
Data about 'exposure' to the different interventions will be collected using questionnaires.
|
after 1 year
|
|
Costs of the strategy and the changed care
Tidsramme: after 1 year
|
Non-adherence to the multidisciplinary NHL guideline may lead to unnecessary medical interventions and more complications, and subsequently to efficiency losses.
This economic evaluation compares the two implementation strategies.
The perspective of this economic evaluation will be a health care perspective.
Both the costs of the implementation strategy and changes in health care consumption will be assessed.
The outcome should facilitate local health care decision making on implementation.
|
after 1 year
|
|
Change from baseline in morbidity
Tidsramme: baseline and 1 year
|
Morbidity is an important outcome measure for the effect of the intervention strategy.
|
baseline and 1 year
|
|
Differences between both groups in Patient Related Outcome Measures (PROMs)
Tidsramme: after 1 year
|
Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.
|
after 1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Rosella Hermens, PhD, Radboud University Nijmegen Medical Center
- Hovedetterforsker: Nelleke Ottevanger, MD, PhD, Radboud University Nijmegen Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Stienen JJ, Hermens RP, Wennekes L, van de Schans SA, Dekker HM, Blijlevens NM, van der Maazen RW, Adang EM, van Krieken JH, Ottevanger PB. Improvement of hospital care for patients with non-Hodgkin's lymphoma: protocol for a cluster randomized controlled trial (PEARL study). Implement Sci. 2013 Jul 9;8:77. doi: 10.1186/1748-5908-8-77.
- Stienen JJ, Ottevanger PB, Wennekes L, van de Schans SA, Dekker HM, Blijlevens NM, van der Maazen RW, van Krieken JH, Hermens RP. Delivering high-quality care to patients with a non-Hodgkin's lymphoma: barriers perceived by patients and physicians. Neth J Med. 2014 Jan;72(1):41-8.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Forventet)
1. desember 2014
Datoer for studieregistrering
Først innsendt
8. mars 2012
Først innsendt som oppfylte QC-kriteriene
22. mars 2012
Først lagt ut (Anslag)
23. mars 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. november 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. november 2014
Sist bekreftet
1. november 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZonMW 171103002
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .