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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Implementation tools
Standard intervention
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non-Hodgkin Lymphoma focused on measuring Non-Hodgkin lymphoma (NHL), Quality of health care, Oncology Service Hospital, Patient-centredness, PROMs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Radboud University Nijmegen Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard implementation strategy

Innovative implementation strategy

Arm Description

Standard intervention

Implementation tools

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change from baseline in morbidity
Morbidity is an important outcome measure for the effect of the intervention strategy.
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.

Full Information

First Posted
March 8, 2012
Last Updated
November 12, 2014
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01562509
Brief Title
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
Official Title
Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
Non-Hodgkin lymphoma (NHL), Quality of health care, Oncology Service Hospital, Patient-centredness, PROMs

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard implementation strategy
Arm Type
Active Comparator
Arm Description
Standard intervention
Arm Title
Innovative implementation strategy
Arm Type
Experimental
Arm Description
Implementation tools
Intervention Type
Other
Intervention Name(s)
Implementation tools
Intervention Description
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
Intervention Name(s)
Standard intervention
Intervention Description
Standard intervention consists of audit&feedback
Primary Outcome Measure Information:
Title
Change from baseline in adherence to quality indicators for NHL care
Description
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.
Time Frame
baseline and 1 year
Secondary Outcome Measure Information:
Title
Exposure to and experiences with the interventions
Description
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.
Time Frame
after 1 year
Title
Costs of the strategy and the changed care
Description
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.
Time Frame
after 1 year
Title
Change from baseline in morbidity
Description
Morbidity is an important outcome measure for the effect of the intervention strategy.
Time Frame
baseline and 1 year
Title
Differences between both groups in Patient Related Outcome Measures (PROMs)
Description
Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.
Time Frame
after 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of non-Hodgkin lymphoma Diagnosed in one of the participating hospitals Able to read and understand Dutch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosella Hermens, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelleke Ottevanger, MD, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23837833
Citation
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.
Results Reference
background
PubMed Identifier
24457441
Citation
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.
Results Reference
background

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

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