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

This study is currently recruiting participants.
Verified January 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01562509
First received: March 8, 2012
Last updated: April 4, 2013
Last verified: January 2013

March 8, 2012
April 4, 2013
October 2012
March 2014   (final data collection date for primary outcome measure)
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.
Change from baseline in adherence to quality indicators for NHL care [ Time Frame: 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.
Complete list of historical versions of study NCT01562509 on ClinicalTrials.gov Archive Site
  • 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.
  • Exposure to and experiences with the interventions [ Time Frame: 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: 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: 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: 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.
Not Provided
Not Provided
 
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
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'.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Non-Hodgkin Lymphoma
  • 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.
  • Other: Standard intervention
    Standard intervention consists of audit&feedback
  • Active Comparator: Standard implementation strategy
    Standard intervention
    Intervention: Other: Standard intervention
  • Experimental: Innovative implementation strategy
    Implementation tools
    Intervention: Other: Implementation tools
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
418
June 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of non-Hodgkin lymphoma
  • Diagnosed in one of the participating hospitals
  • Able to read and understand Dutch
Both
18 Years and older
No
Contact: Jozette Stienen, MSc 0031243667310 J.Stienen@iq.umcn.nl
Netherlands
 
NCT01562509
ZonMW 171103002
No
Radboud University
Radboud University
Not Provided
Principal Investigator: Rosella Hermens, PhD Radboud University Nijmegen Medical Center
Principal Investigator: Nelleke Ottevanger, MD, PhD Radboud University Nijmegen Medical Center
Radboud University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP