PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
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Purpose
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'.
| Condition | Intervention |
|---|---|
|
Non-Hodgkin Lymphoma |
Other: Implementation tools Other: Standard intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma |
- Change from baseline in adherence to quality indicators for NHL care [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]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.
- Exposure to and experiences with the interventions [ Time Frame: after 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: after 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]Morbidity is an important outcome measure for the effect of the intervention strategy.
- Differences between both groups in Patient Related Outcome Measures (PROMs) [ Time Frame: after 1 year ] [ Designated as safety issue: No ]Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.
| Estimated Enrollment: | 418 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of non-Hodgkin lymphoma
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Contacts and Locations| Contact: Jozette Stienen, MSc | 0031243667310 | J.Stienen@iq.umcn.nl |
| Netherlands | |
| Radboud University Nijmegen Medical Center | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Contact: J Stienen J.Stienen@iq.umcn.nl | |
| Principal Investigator: Rosella Hermens, PhD | |
| Principal Investigator: | Rosella Hermens, PhD | Radboud University Nijmegen Medical Center |
| Principal Investigator: | Nelleke Ottevanger, MD, PhD | Radboud University Nijmegen Medical Center |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01562509 History of Changes |
| Other Study ID Numbers: | ZonMW 171103002 |
| Study First Received: | March 8, 2012 |
| Last Updated: | April 4, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Non-Hodgkin lymphoma (NHL) Quality of health care Oncology Service Hospital Patient-centredness PROMs |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013