NCT01562509

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'.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
418

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

March 8, 2012

Last Update Submit

November 12, 2014

Conditions

Non-Hodgkin Lymphoma

Keywords

Non-Hodgkin lymphoma (NHL)Quality of health careOncology Service HospitalPatient-centrednessPROMs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Exposure to and experiences with the interventions

    after 1 year

  • Costs of the strategy and the changed care

    after 1 year

  • Change from baseline in morbidity

    baseline and 1 year

  • Differences between both groups in Patient Related Outcome Measures (PROMs)

    after 1 year

Study Arms (2)

Standard implementation strategy

ACTIVE COMPARATOR

Standard intervention

Other: Standard intervention

Innovative implementation strategy

EXPERIMENTAL

Implementation tools

Other: Implementation tools

Interventions

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.

Innovative implementation strategy
Standard interventionOTHER

Standard intervention consists of audit\&feedback

Standard implementation strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 23837833BACKGROUND

  • 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.

    PMID: 24457441BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rosella Hermens, PhD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

  • Nelleke Ottevanger, MD, PhD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 23, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

NL(1)