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

NCT ID: NCT01562509

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

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.

Conditions

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard implementation strategy

Standard intervention

Group Type ACTIVE_COMPARATOR

Standard intervention

Intervention Type OTHER

Standard intervention consists of audit\&feedback

Innovative implementation strategy

Implementation tools

Group Type EXPERIMENTAL

Implementation tools

Intervention Type OTHER

* 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.

Interventions

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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.

Intervention Type OTHER

Standard intervention

Standard intervention consists of audit\&feedback

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosella Hermens, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Nelleke Ottevanger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Locations

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Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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Stienen JJ, Hermens RP, Wennekes L, van de Schans SA, Dekker HM, Blijlevens NM, van der Maazen RW, Adang EM, van Krieken JH, Ottevanger PB. Improvement of hospital care for patients with non-Hodgkin's lymphoma: protocol for a cluster randomized controlled trial (PEARL study). Implement Sci. 2013 Jul 9;8:77. doi: 10.1186/1748-5908-8-77.

Reference Type BACKGROUND
PMID: 23837833 (View on PubMed)

Stienen JJ, Ottevanger PB, Wennekes L, van de Schans SA, Dekker HM, Blijlevens NM, van der Maazen RW, van Krieken JH, Hermens RP. Delivering high-quality care to patients with a non-Hodgkin's lymphoma: barriers perceived by patients and physicians. Neth J Med. 2014 Jan;72(1):41-8.

Reference Type BACKGROUND
PMID: 24457441 (View on PubMed)

Other Identifiers

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ZonMW 171103002

Identifier Type: -

Identifier Source: org_study_id