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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma

Conditions
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Non-Hodgkin Lymphoma

Intervention / Treatment
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* Other: Implementation tools
* Other: Standard intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of non-Hodgkin lymphoma Diagnosed in one of the participating hospitals Able to read and understand Dutch

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard implementation strategy<br>Standard intervention | Other: Standard intervention<br>* Standard intervention consists of audit&feedback<br>|
| Experimental: Innovative implementation strategy<br>Implementation tools | Other: Implementation tools<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in adherence to quality indicators for NHL care | 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. | baseline and 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin lymphoma (NHL), Quality of health care, Oncology Service Hospital, Patient-centredness, PROMs