Patient-reported Outcome Scale in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— PAN-PROMISE  

Official title:

Patient-reported Outcome Scale in Acute pancreatitis-an International Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650062
• Other study ID #: PI2016/69
• Status: Completed
• Start date: May 30, 2017
• Est. completion date: February 3, 2019

Study information

• Verified date: February 2019
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The PAN-PROMISE study (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis-an international proSpEctive cohort study) aims to measure an outcome variable in acute pancreatitis (AP) based in the patient´s experience. PAN-PROMISE is a cohort study involving patients with AP. The patient´s symptom perception will be compared with the opinion of the clinicians and with clinical outcomes.

Description:

Currently, the most important outcome variables in Acute Pancreatitis (AP) are persistent organ failure (POF) and mortality, according to the physician point of view. These variables occur infrequently (<10 and <5% respectively) (Sternby et all, see "References"), therefore, studies designed to assess the effectiveness of new treatments for AP to decrease POF or mortality require a very large sample of patients, which is unfeasible. Currently, clinical trials addressing the management of AP do not take into account Patient Reported Outcome Measures.

PROMS (Patient Reported Outcome Measures) have been defined as any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else (first link in "References"). PROMS are gaining importance as a tool to design outcome variables. This kind of measurement has been recently included in the quality assesment approaches (Crossing the Quality Chasm: A New Health System for the 21st Century, see "References"), being PROMS a useful tool to improve the triple aim framework of better quality, appropriate utilization, and enhanced patient experience (second link in "References"). The aim of PAN-PROMISE is to incorporate an outcome variable in AP based in the patient´s experience. For this purpose the investigators involved in this project have developed a new instrument based on symptoms found to be important for the patient. This new instrument is intended to be a simple quantitative variable, relevant for the patient, that can be useful to test new treatments for AP without the need for a very large sample size, fulfilling the requirements of the triple aim framework by incorporating an outcome measurement defined by the patient.

Hypothesis:

• PROMS must be incorporated to patient care and research in AP to improve the triple aim framework of better quality, appropriate utilization, and enhanced patient experience

• A PROMS scale is a useful outcome variable to investigate new treatments in AP

• The different severity categories of the revision of the Atlanta Classification (RAC) have different scores on the PROMS scale in acute pancreatitis: severe greater than moderate and mild, moderate greater than mild.

• Increasing scores on the PROMS scale are associated to increased morbidity

Aims:

• Main aim 1: to measure patient´s symptoms during an episode of AP and to correlate the intensity of these symptoms to clinical outcomes

• Main aim 2: to design and validate a PROMS scale in AP intended to be an suitable outcome variable in future trials addressing the management of AP

Methods

Part 1: development of the PAN-PROMISE instrument The PAN-PROMISE research team developed a qualitative study in which three nominal groups were conducted, two with patients who had suffered an acute pancreatitis (AP) in hospitals in Alicante (Universitarian General Hospital)), and Valencia (Clinic Hospital), Spain and another with clinicians from the Alicante region with experience in treating patients with AP. Participants were asked about the symptoms that cause the most discomfort and concern to patients at three specific times: before receiving treatment for AP, during hospital admission and after discharge. The perspectives of patients and professionals were compared. From the information gathered in the nominal groups, a first version of a PROMS questionnaire was elaborated and shared with an international group of gastroenterologists, experienced in the management of pancreatitis, from 4 countries (Germany, Spain, USA, India and Turkey) through an online application to determine to what extent these experiences were shared in frequency and intensity by patients in these different countries. With all this information, a PROMS instrument was generated.

Part 2: measurement of patient´s symptoms in an international cohort study

2.1 Design. The PAN-PROMISE instrument is being measured in patients participating in a multicenter international prospective cohort study. Consecutive adult patients with AP are eligible after signed informed consent.

2.2 Center recruitment The PAN-PROMISE study has been endorsed by the Spanish Association of Pancreatology (AESPANC), the Spanish Association of Gastroenterology (AEG) and the International Association of Pancreatology (IAP); these associations shared the project with their members and through their social networks, calling for researchers and centers to join this initiative. PAN-PROMISE has also a webpage www.promisepancreatitis.com to promote center recruitment.

2.3 Patient registry PAN-PROMISE measurement will rely on a patient registry hosted in the Spanish Association of Gastroenterology (AEG) REDCap node. AEG offered this REDCap web-based online patient registry tool at no cost. Claudia Sánchez-Marin, a gastroenterologist, is on charge of quality control (data validation, data checks, contact with researchers to solve issues). The REDCap online registry was designed with logical rules to ensure good quality data entry, including mandatory fields to enter, logical ranges for quantitative variables, alarms if logical rules are not coherent (for example to have persistent organ failure but to classify the episode as mild or moderate), expanding fields only available in the presence of certain circumstances (for example, detailed organ failure description is only available if the patient had organ failure).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: February 3, 2019
• Est. primary completion date: February 3, 2019
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients =18 and <80 years.

• Karnofsky performance status previous to AP 100 (normal, no complaints, no evidence of disease), 90 (able to carry on normal activity; minor signs or symptoms of disease) or 80 (normal activity with effort; some signs or symptoms of disease).

• Acute pancreatitis defined as at least 2 of the following 3 criteria: A) Typical abdominal pain, B) Elevation of amylase and/or lipase more than 3 times the upper limit of normality, and C) Imaging (preferably CT and/or MR) compatible with AP.

• Written informed consent.

Exclusion Criteria:

• Time between onset of symptoms and presentation in the emergency room (ER) greater than 48 hours (we do not consider as onset of symptoms previous self-limited heraldic biliary pain)

• Recruitment >24h after presentation in the ER

• Karnofsky performance status previous to AP 70 (Cares for self; unable to carry on normal activity or to do active work) or less

• Inability to express or understand the instructions of the study (severe congenital or acquired intellectual deficit).

• More than 1 previous episode of AP.

• Chronic pancreatitis.

• Presence of diseases or conditions different from AP that may interfere with the scale: other causes of abdominal pain (especially acute cholecystitis; Note: choledocholithiasis-acute cholangitis is not an exclusion criteria), obstruction of the digestive tract (peptic pyloric stenosis, gastrointestinal anastomotic stenosis, diabetic gastroparesis, gastrointestinal neoplasia...), nausea-vomiting (brain tumor, chemotherapy...) or weakness (pre-existing anemia with Hb <9 mg/dL, heart failure or respiratory insufficiency associated with minimal effort dyspnea, or domiciliary treatment with O2, advanced neoplasms or other debilitating diseases).

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
Colombia	Hospital Universitario San Ignacio	Bogotá
Greece	Attikon University Hospital	Athens
Hungary	Centre for Translational Medicine, University of Pécs	Pécs
Hungary	University of Szeged	Szeged
Italy	Dip.Medicina-Università degli Studi di Verona	Verona
Korea, Republic of	Konkuk University School of Medicine	Seoul
Lithuania	Vilnius University	Vilnius
Mexico	Servicio de Cirugía General, IMSS, León	Guanajuato
Poland	Medical University of Lódz	Lódz
Portugal	Fernando Fonseca Hospital	Amadora
Portugal	Centro Hospitalar Tondela-Viseu	Viseu
Romania	Emergency Hospital of Bucharest	Bucharest
Romania	Iuliu Hatieganu University of Medicine and Pharmacy	Cluj-Napoca
Russian Federation	Immanuel Kant Baltic Federal University	Kaliningrad
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Santa María	Lleida
Spain	Hospital San Pedro	Logroño
Spain	Hospital Central de Asturias	Oviedo
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Alvaro Cunqueiro	Vigo
Spain	Hospital Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza
Ukraine	Medical Institute Lviv	Lviv
United States	Johns Hopkins Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Enrique de-Madaria

Countries where clinical trial is conducted

United States,  Colombia,  Greece,  Hungary,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Ukraine, 

References & Publications (2)

Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. — View Citation

Sternby H, Bolado F, Canaval-Zuleta HJ, Marra-López C, Hernando-Alonso AI, Del-Val-Antoñana A, García-Rayado G, Rivera-Irigoin R, Grau-García FJ, Oms L, Millastre-Bocos J, Pascual-Moreno I, Martínez-Ares D, Rodríguez-Oballe JA, López-Serrano A, Ruiz-Rebol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of acute pancreatitis according to the revised Atlanta classification [incidence of local and/or systemic complications]	Mild acute pancreatitis (no complications), moderately severe acute pancreatitis (local complications and/or transient (=48h) organ failure and/or exacerbation of previous comorbidity), severe acute pancreatitis (persistent (>48h) organ failure) (see revised Atlanta classification, Banks et al, Gut 2013)	Up to 15 days after hospital discharge from index hospital admission
Primary	PAN-PROMISE patient reported outcome measurement instrument	PROMISE SCALE (Patient-reported Outcome Scale in Acute pancreatitis) Each item is scored from 0 to 10 ( worst score in the last 24h): 0 none, 10: the highest possible intensity according to the patient; Pain, especially in the abdomen, chest or back; Abdominal distention (bloating, sensation of excess gas); Difficulty eating, sensation of food being stuck in the stomach; Difficulty with bowel movements (constipation or straining on bowel movements); Nausea and/or vomiting; Thirst; Weakness, lack of energy, fatigue, difficulty moving	From within 24h after admission to 15 days after discharge
Secondary	EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30) Version 3.0	EORTC QLQ-C30, a widely used and validated quality of life scale, includes 28 questions with a four-point scale: "Not at all" (1 point), "A little" (2), "Quite a bit" (3) and "Very much." (4); 4 means an important impact on quality of life. The last 2 questions are scored from 1 (very poor) to 7 (excellent), being 7 indicative of excellent quality of life.	15 days after hospital discharge
Secondary	C-reactive protein	A marker of inflammation	48 and 72h after recruitment
Secondary	Local complications (incidence of pancreatic/peripancreatic necrosis and acute peripancreatic fluid collections)	Defined according to the revised Atlanta classification (Banks et al, Gut 2013)	Up to 15 days after hospital discharge from index hospital admission
Secondary	Need for invasive treatment	Endoscopic, percutaneous or surgical drainage or necrosectomy	Up to 15 days after hospital discharge from index hospital admission
Secondary	Need for nutritional support	Need for enteral and/or parenteral nutritional support	Up to 15 days after hospital discharge from index hospital admission
Secondary	Admission in the Intensive Care Unit	Need for intensive care support	Up to 15 days after hospital discharge from index hospital admission
Secondary	Hospital stay	Days, on index admission	Up to 15 days after hospital discharge from index hospital admission
Secondary	Organ failure	Transient and persistent organ failure defined according to the revised Atlanta classification (Banks et al, Gut 2013)	Up to 15 days after hospital discharge from index hospital admission
Secondary	Mortality	Mortality during index admission	Up to 15 days after hospital discharge from index hospital admission
Secondary	Hospital readmission	Hospital readmission due to symptom relapse or complications of index acute pancreatitis	Up to 15 days after hospital discharge from index hospital admission
Secondary	Systemic Inflammatory Response Syndrome (SIRS)	Presence of SIRS and persistent (>48h) SIRS	Up to 15 days after hospital discharge from index hospital admission

External Links

•   Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
•   Institute for Healthcare Improvement (IHI): The IHI Triple Aim