Implementation study of an evidence-based management algorithm for chronic pancreatitis patients
| ISRCTN | ISRCTN13042622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13042622 |
| Secondary identifying numbers | NL8556 |
- Submission date
- 01/09/2020
- Registration date
- 05/09/2020
- Last edited
- 09/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Chronic pancreatitis is a condition where the pancreas has become permanently damaged from inflammation and stops working properly. The pancreas is a small organ, located behind the stomach, that helps with digestion. Chronic pancreatitis can affect people of any age, but it usually develops between the ages of 30 and 40 as a result of heavy drinking over many years. It's more common in men.
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.
The aim of the present study is 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.
Who can participate?
Chronic pancreatitis patients who meet the inclusion and exclusion criteria and are receiving active treatment in one of the participating centers of the Dutch Pancreatitis Study Group.
What does the study involve?
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 until the end of the study. In the end, this evidence-based management algorithm will be implemented in all participating hospitals. The evidence-based management algorithm consists of a combination of interventions, based on the recommendation of the United European Gastroenterology evidence-based guidelines will be compared with care according to current practice.
What are the possible benefits and risks of participating?
There are no additional/potential risks for participating in this trial. Possible benefits: During the intervention phase all participating patients will be treated according to our standardized evidence-based management algorithm.
Where is the study run from?
Dutch Pancreatitis Study Group, St. Antonius Hospital (The Netherlands)
When is the study starting and how long is it expected to run for?
July 2020 to July 2023
Who is funding the study?
Mylan (The Netherlands)
Who is the main contact?
Prof. dr. M. Bruno, m.bruno@erasmusmc.nl
Dr. F.E.M. de Rijk , f.de.rijk@antoniusziekenhuis.nl
Contact information
Scientific
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
| Phone | +31 (0)88 3207050 |
|---|---|
| f.de.rijk@antoniusziekenhuis.nl |
Study information
| Study design | Nationwide stepped-wedge cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Stepped-wedge cluster randomized controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://combo-studie.nl/ (in Dutch) |
| Scientific title | Implementation study of an evidence-based management algorithm for patients with chronic pancreatitis: a nationwide stepped-wedge cluster randomized controlled trial (COMBO trial) |
| Study acronym | COMBO |
| Study objectives | The aim of this study is to investigate whether the implementation of an evidence-based management algorithm consisting of a combination of interventions for the management of chronic pancreatitis (CP) results in an improvement of patient outcomes. |
| Ethics approval(s) | On 21/04/2020 the MEC-U (Medical Research Ethics Committees United; Postbus 2500, 3430 EM Nieuwegein, Koekoekslaan 1, Netherlands; +31 (0)88 3208784; info@mec-u.nl) ruled that this study is not subject to the Medical Research Involving Human Subjects Act (WMO), ref: W20.074 |
| Health condition(s) or problem(s) studied | Chronic pancreatitis |
| Intervention | 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. The evidence-based management algorithm consists 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 extensive systematic literature analysis. The interventions included in this algorithm are particularly focused on education of both physicians and patients, management of risk factors for disease progression and regular screening for and treatment of complications of chronic pancreatitis. The final algorithm has been critically reviewed by the advisory committee of international experts in the field of chronic pancreatitis before implementation in this trial. Follow up will be 18 months after the start of the intervention. |
| Intervention type | Other |
| Primary outcome measure | 1. Quality of life measured using PANQOLI-questionnaire and EQ5D questionnaire at baseline, start of intervention and 1 year after start of intervention 2. Pain measured using Izbicki questionnaire at baseline, start of intervention and 12 months after start of intervention |
| Secondary outcome measures | 1. Individual clinical outcomes measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention 2. Risk factors for disease progression measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention 3. Healthcare resource utilization measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention 4. Social participation measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention 5. Annual costs measured using data from medical records combined with data from questionnaires at start of intervention and 12 months after start of intervention |
| Overall study start date | 02/07/2020 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 CP patients with a time since diagnosis ≤3 years |
| Key inclusion criteria | 1. Age ≥18 years 2. A diagnosis of CP according to the M-ANNHEIM criteria 3. Active treatment in one of the participating hospitals 4. Provided written informed consent (IC) |
| Key exclusion criteria | 1. Women who are pregnant 2. End-stage diseases (<6 months estimated survival) due to cancer, chronic obstructive pulmonary disease and/or congestive heart failure 3. Suspected or established pancreatic malignancies 4. Uncompensated cirrhosis 5. Renal failure (GFR <25 ml/min or who are on dialysis) |
| Date of first enrolment | 07/09/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Amsterdam
1105 AZ
Netherlands
Amsterdam
1081 HV
Netherlands
Breda
4819 EV
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Netherlands
Sponsor information
Research organisation
St. Antonius Ziekenhuis
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
| Phone | +31 (0)88 320 30000 |
|---|---|
| info@pancreatitis.nl | |
| Website | https://www.pancreatitis.nl/ |
"ROR" |
https://ror.org/007r3zy44 |
Research organisation
Department of Gastroenterology
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 7040704 |
|---|---|
| f.derijk@erasmusmc.nl | |
| Website | http://www.erasmusmc.nl/ |
|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The researchers would like to publish their study protocol in the future, so for now this protocol is not available online for non-participating centers. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/01/2023 | 09/01/2023 | Yes | No |
Editorial Notes
09/01/2023: Publication reference added.
04/10/2022: The recruitment end date was changed from 30/09/2022 to 31/12/2022.
08/03/2022: The recruitment end date was changed from 31/03/2022 to 30/09/2022.
01/06/2021: The recruitment end date was changed from 31/12/2021 to 31/03/2022.
03/09/2020: Trial’s existence confirmed by Medical Research Ethics Committees United.
