Non-Hodgkin LymphomaNCT01562509
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
A study testing Implementation tools and Standard intervention in people with Non-Hodgkin Lymphoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Implementation tools and Standard intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of non-Hodgkin lymphoma
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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'.
Read the 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.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Implementation tools, Standard intervention
- Keywords
- Non-Hodgkin lymphoma (NHL), Quality of health care, Oncology Service Hospital, Patient-centredness, PROMs
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation toolsOther
- 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.
Standard interventionOther
Standard intervention consists of audit\&feedback
| Study group | Role | What they receive |
|---|---|---|
| Standard implementation strategy | Active comparator | Standard intervention Receives: Other: Standard intervention |
| Innovative implementation strategy | Experimental | Implementation tools Receives: Other: Implementation tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: after 1 year
Change from baseline in morbidity
Morbidity is an important outcome measure for the effect of the intervention strategy.
Measured: 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.
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosella Hermens, PhD, Principal investigator, Radboud University Nijmegen Medical CenterNelleke Ottevanger, MD, PhD, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562509
- Sponsor's protocol ID
- ZonMW 171103002
- Status last verified
- Nov 2014
- First submitted
- 8 Mar 2012
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23837833Stienen 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.
PubMed 24457441
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01562509
- Acronym / sponsor ID
- ZonMW 171103002
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Non-Hodgkin lymphoma (NHL), Quality of health care, Oncology Service Hospital, Patient-centredness, PROMs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard implementation strategy | Active comparator | Other: Standard interventionStandard intervention |
| Innovative implementation strategy | Experimental | Other: Implementation toolsImplementation tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of non-Hodgkin lymphoma
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Innovative implementation strategy |
| Standard interventionStandard intervention consists of audit\&feedback | Other | Standard implementation strategy |
Primary outcome
Change from baseline in adherence to quality indicators for NHL care
Time frame: baseline and 1 year
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.
4 secondary outcomes
Exposure to and experiences with the interventions
Time frame: after 1 year
Costs of the strategy and the changed care
Time frame: after 1 year
Change from baseline in morbidity
Time frame: baseline and 1 year
Differences between both groups in Patient Related Outcome Measures (PROMs)
Time frame: after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 23837833Stienen 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.
- Background: PubMed 24457441Stienen 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.
Related trials for Non-Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosella Hermens, PhD principal investigator
Radboud University Nijmegen Medical Center
Nelleke Ottevanger, MD, PhD principal investigator
Radboud University Nijmegen Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation tools and Standard intervention in people with Non-Hodgkin Lymphoma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in adherence to quality indicators for NHL care (time frame: baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.