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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01562509
First received: March 8, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention
Non-Hodgkin Lymphoma
Other: Implementation tools
Other: Standard intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Change from baseline in adherence to quality indicators for NHL care [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    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:
  • Exposure to and experiences with the interventions [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    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.

  • Costs of the strategy and the changed care [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in morbidity [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    Morbidity is an important outcome measure for the effect of the intervention strategy.

  • Differences between both groups in Patient Related Outcome Measures (PROMs) [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.


Estimated Enrollment: 418
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of non-Hodgkin lymphoma
  • Diagnosed in one of the participating hospitals
  • Able to read and understand Dutch
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562509

Locations
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Rosella Hermens, PhD Radboud University Nijmegen Medical Center
Principal Investigator: Nelleke Ottevanger, MD, PhD Radboud University Nijmegen Medical Center
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01562509     History of Changes
Other Study ID Numbers: ZonMW 171103002
Study First Received: March 8, 2012
Last Updated: May 5, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Non-Hodgkin lymphoma (NHL)
Quality of health care
Oncology Service Hospital
Patient-centredness
PROMs

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014