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PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562509
Recruitment Status : Unknown
Verified November 2014 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : November 13, 2014
Information provided by (Responsible Party):
Radboud University

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'.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Other: Implementation tools Other: Standard intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
Study Start Date : October 2012
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: Standard implementation strategy
Standard intervention
Other: Standard intervention
Standard intervention consists of audit&feedback

Experimental: Innovative implementation strategy
Implementation tools
Other: 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 Outcome Measures :
  1. Change from baseline in adherence to quality indicators for NHL care [ Time Frame: 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.

Secondary Outcome Measures :
  1. Exposure to and experiences with the interventions [ Time Frame: 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.

  2. Costs of the strategy and the changed care [ Time Frame: 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.

  3. Change from baseline in morbidity [ Time Frame: baseline and 1 year ]
    Morbidity is an important outcome measure for the effect of the intervention strategy.

  4. Differences between both groups in Patient Related Outcome Measures (PROMs) [ Time Frame: after 1 year ]
    Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562509

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Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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Principal Investigator: Rosella Hermens, PhD Radboud University Nijmegen Medical Center
Principal Investigator: Nelleke Ottevanger, MD, PhD Radboud University Nijmegen Medical Center
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Responsible Party: Radboud University Identifier: NCT01562509    
Other Study ID Numbers: ZonMW 171103002
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Radboud University:
Non-Hodgkin lymphoma (NHL)
Quality of health care
Oncology Service Hospital
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases