Clinical trial NCT01562509: PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
Official title: Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Hodgkin Lymphoma
Keywords: Non-Hodgkin lymphoma (NHL)
Quality of health care
Oncology Service Hospital
Patient-centredness
PROMs
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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'.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in adherence to quality indicators for NHL care
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Exposure to and experiences with the interventions
timeFrame: after 1 year
measure: Costs of the strategy and the changed care
timeFrame: after 1 year
measure: Change from baseline in morbidity
timeFrame: baseline and 1 year
measure: Differences between both groups in Patient Related Outcome Measures (PROMs)
timeFrame: after 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Rosella Hermens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Center
name: Nelleke Ottevanger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.