No registrations found.
ID
Source
Brief title
Health condition
Chronic pancreatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are two co-primary outcomes: quality of life assessed with a pancreatitis quality of life questionnaire and pain severity assessed with the Izbicki-pain score. Both will be measured longitudinally in all included patients.
Secondary outcome
1. Individual components of both co-primary outcomes
2. Process measure outcomes
3. Individual clinical outcomes
4. Participation at work
5. Healthcare resource utilization
6. Direct- and indirect costs
Background summary
Rationale: Chronic pancreatitis is associated with a markedly reduced life-expectancy and quality of life. In a recently performed study, current care for patients with chronic pancreatitis in the Netherlands proved not to be in accordance with the in 2017 published European guideline. This may indicate suboptimal care for these patients. Implementation of an evidence-based management algorithm to standardize care could improve this level of care, lower the complication rate and improve the quality of life for patients with chronic pancreatitis.
Objective: To assess whether standardized care through the implementation of an evidence-based management algorithm of interventions for patients with chronic pancreatitis results in an improvement in quality of life and reduction of pain severity as compared to current practice.
Study design: A nationwide stepped-wedge, cluster randomized controlled trial. All participating hospitals cross over from current practice to care according to the treatment algorithm. The sequence of crossing over is randomized. Study participants will be enrolled during the current practice phase and be followed longitudinally until the end of the study. In the end, this evidence-based management algorithm will be implemented in all participating hospitals.
Intervention: Evidence-based management algorithm
Comparison: Care for chronic pancreatitis patients according to current practice.
Endpoints: In this study, there are two co-primary outcomes: quality of life and pain severity. Both will be measured longitudinally in all included patients. Follow-up period will be a minimum of 12 months after start intervention.
Study objective
The hypothesis of this study is that implementation of an evidence-based management algorithm to standardize care will improve the level of care, lower the complication rate and improve the quality of life for patients with chronic pancreatitis.
Study design
The patient follow-up will be completed 35 months after randomization to determine the order in which each cluster group will undergo the cross-over.
Intervention
Evidence-based management algorithm consisting of a combination of interventions, all considered as part of best practice, based on the recommendations of the United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (2017) and an extensive systematic literature analysis.
Inclusion criteria
- An age ≥ 18 years
- A diagnosis of CP according to the M-ANNHEIM criteria
- Active treatment in one of the participating hospitals
- Provided written informed consent (IC)
Exclusion criteria
- Pregnancy
- End-stage diseases (< 6 months estimated survival) due to cancer, chronic obstructive pulmonary disease and/or congestive heart failure
- Suspected or established pancreatic malignancies
- Uncompensated cirrhosis
- Renal failure (GFR < 25 ml/min or who are on dialysis)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8556 |
| Other | MEC-U : W20.074 |