This trial is active, not recruiting.

Condition non-hodgkin lymphoma
Treatments implementation tools, standard intervention
Sponsor Radboud University
Start date October 2012
End date November 2014
Trial size 418 participants
Trial identifier NCT01562509, ZonMW 171103002


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'.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(Active Comparator)
Standard intervention
standard intervention
Standard intervention consists of audit&feedback
Implementation tools
implementation tools
Professionals receive audit & feedback Patients (and clinicians) have access to a website with information tailored to patients with an NHL. This website gives insight into the logistic processes of each diagnostic tool and into the patients' personal care pathway. Standardization of diagnostic and evaluative request forms and reports for clinicians. Supporting material for standardizing the procedure for multidisciplinary meetings.

Primary Outcomes

Change from baseline in adherence to quality indicators for NHL care
time frame: baseline and 1 year

Secondary Outcomes

Exposure to and experiences with the interventions
time frame: after 1 year
Costs of the strategy and the changed care
time frame: after 1 year
Change from baseline in morbidity
time frame: baseline and 1 year
Differences between both groups in Patient Related Outcome Measures (PROMs)
time frame: after 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical diagnosis of non-Hodgkin lymphoma - Diagnosed in one of the participating hospitals - Able to read and understand Dutch

Additional Information

Official title Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
Principal investigator Rosella Hermens, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Radboud University.