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

Not Applicable

• Conditions: Non-Hodgkin Lymphoma
• Interventions: Other: Standard intervention; Other: Implementation tools

• Registration Number: NCT01562509
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Study Start: 2012-10
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-13
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard implementation strategy	Standard intervention	Standard intervention
Innovative implementation strategy	Implementation tools	Implementation tools

Primary Outcome Measures

Name	Time	Method
Change from baseline in adherence to quality indicators for NHL care	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

Name	Time	Method
Exposure to and experiences with the interventions	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.
Costs of the strategy and the changed care	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.
Change from baseline in morbidity	baseline and 1 year	Morbidity is an important outcome measure for the effect of the intervention strategy.
Differences between both groups in Patient Related Outcome Measures (PROMs)	after 1 year	Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands