Construction and Evaluation of a Stoma Patient Care Network

Construction and Evaluation of a Uniform Stoma Patient Care Network in Shaanxi Province

Establish a uniform care network for stoma patients in Shaanxi Province and evaluate its effectiveness, so that stoma patients can get the same quality of stoma care outside the hospital.

Study Overview

• Status: Recruiting
• Conditions: Surgical Stomas
• Intervention / Treatment: Other: uniform care; Other: conventional care

Detailed Description

This project plans to take the First Affiliated Hospital of Xi'an Jiaotong University as the lead hospital to establish a uniform care network for stoma patients in Shaanxi Province. This network includes the management system of stoma nursing and the management organization of stoma patients in Shaanxi Province. It formulates the whole quality standard of stoma nursing in Shaanxi Province, carries out "standard training" for the stoma specialty nurses in the group, and carries out on-site inspection in various hospitals from time to time, establishes the feedback mechanism and standardizes the stoma nursing process. The contact card of stoma therapists was made and distributed to patients with stoma, so that patients can easily get the information of stoma therapists in the nearest hospital and receive professional and convenient care. WeChat group of specialized stoma nurses was established to provide remote guidance for difficult cases, share new stoma ideas and knowledge, and facilitate communication among stoma nurses in the group. The leading hospital holds training courses on knowledge and progress of stomatology every year, competitions on knowledge and skills, and dispatches therapists to provide work guidance, so as to share new knowledge, skills and scientific research abilities. At the same time, the efficacy of the network was evaluated by investigating the complication rate, self-care ability, quality of life, medical costs of stoma patients,as well as the specialized nursing skills and professional development of nurses.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sijie Chen; Phone Number: 0086-17373560562; Email: 1031092940@qq.com
• Study Contact Backup: Name: Xiulin Wen; Phone Number: 0086-13991893501; Email: 332919997@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University
      • Contact: Sijie Chen; Phone Number: 0086-17373560562; Email: 1031092940@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged ≥18 years old;
• patients undergoing enterostomy;
• patients with primary school and above education level;
• patients with clear consciousness, reading and verbal expression ability;
• patients could reexamine regularly;
• patients informed consent and voluntary participation in the study.

Exclusion Criteria:

• patients with organ dysfunction who have difficulty in self-care;
• patients with mental illness, consciousness disorder or communication disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Nurses provide uniform care to patients according to the quality standards.	Other: uniform care; The leader develops training plan and trains nurses, who provide uniform care and education to patients according to the training.
Placebo Comparator: control group; Nurses provide the routine care to patients.	Other: conventional care; Nurses carry out the routine care procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by Stoma Quality of Life (Stoma-QOL).	The scale includes 20 items with a score ranging from 20 to 80 points. The higher the score, the better the quality of life.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-care ability measured by stoma self-care ability scale	The scale includes three dimensions: self intention questionnaire (12-48 points), self-care knowledge (0-21 points), self-care skills (0-12 points). The higher the score, the higher the self-care ability.	6 months
Stoma complications	Stoma complications include infection around the stoma，parastomal hernia，skin and mucous membrane separation，fistula of stoma，hemorrhage，ischemia，and stenosis．	6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Xia Xin, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019SF-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No