Care Pathways for Colorectal Cancer Surgery (CP4GICAN)

• ClinicalTrials.gov Identifier: NCT02965794
• Recruitment Status: Completed
• First Posted: November 17, 2016
• Last Update Posted: January 28, 2020
• Sponsor: European Pathway Association
• Collaborator: KU Leuven
• Information provided by (Responsible Party): Dr. Kris Vanhaecht, European Pathway Association

Study Description

Brief Summary:

EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY

Condition or disease	Intervention/treatment
Cancer	Other: Care pathways for colorectal cancer

Detailed Description:

This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12). They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.

Study Design

• Study Type: Observational
• Actual Enrollment: 480 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Descriptive Study to Evaluate the Care Process and the Quality of Care for Adult Cancer Patients Who Are Admitted for Colorectal Cancer Surgery.
• Study Start Date: October 2014
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: November 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Usual care; quality of care will be measured in the participating hospitals, using a retrospective patient record analysis
Care Pathway; Care pathways for colorectal cancer	Other: Care pathways for colorectal cancer; development of a care pathway for this patient group; Other Names: care pathway; clinical pathway; critical pathway

Outcome Measures

Primary Outcome Measures :

1. Length of stay [ Time Frame: through study completion, an average of 4 months ]
   Number of days in hospital

Secondary Outcome Measures :

1. Time to return to normal diet [ Time Frame: through study completion, an average of 4 months ]
   number of days in between surgery and day of normal diet

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Adults undergoing surgery for colorectal cancer

Criteria

Inclusion Criteria:

1. All consecutive scheduled admissions starting September 2, 2013;
2. Minimum age of 18 years;
3. Elective admission for colorectal cancer surgery

Exclusion Criteria:

1. Emergency (not planned) admission for colorectal cancer surgery;
2. Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.

Contacts and Locations

Locations

Belgium

KULeuven

Leuven, Belgium, 3000

Sponsors and Collaborators

European Pathway Association

KU Leuven

Investigators

• Principal Investigator: Kris Vanhaecht, PhD; KU Leuven

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van Zelm R, Coeckelberghs E, Sermeus W, Wolthuis A, Bruyneel L, Panella M, Vanhaecht K. A mixed methods multiple case study to evaluate the implementation of a care pathway for colorectal cancer surgery using extended normalization process theory. BMC Health Serv Res. 2021 Jan 4;21(1):11. doi: 10.1186/s12913-020-06011-w.

• Responsible Party: Dr. Kris Vanhaecht, Professor in Healthcare Quality Management, European Pathway Association
• ClinicalTrials.gov Identifier: NCT02965794
• Other Study ID Numbers: CP4NutriGICAN2014
• First Posted: November 17, 2016
• Last Update Posted: January 28, 2020
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Dr. Kris Vanhaecht, European Pathway Association:

surgery; bowel; rectum; cancer; nutrition

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases