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'.

Study Overview

• Status: Unknown
• Conditions: Non-Hodgkin Lymphoma
• Intervention / Treatment: Other: Standard intervention; Other: Implementation tools

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 Type: Interventional
• Enrollment (Anticipated): 418
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard implementation strategy; Standard intervention	Other: Standard intervention; Standard intervention consists of audit&feedback
Experimental: Innovative implementation strategy; Implementation tools	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Rosella Hermens, PhD, Radboud University Nijmegen Medical Center; Principal Investigator: Nelleke Ottevanger, MD, PhD, Radboud University Nijmegen Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Non-Hodgkin lymphoma (NHL); Patient-centredness; Quality of health care; Oncology Service Hospital; PROMs
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: ZonMW 171103002