Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- H.A.D.S. (Hospital Anxiety and Depression Scale)
研究概览
简要总结
This is a multicenter, non-pharmacological, experimental, prospective, randomized study, with two arms (1:1) in a single-blind design. The study aims to evaluate the effectiveness of a tele-consultation procedure in patients undergoing elective colonoscopy in terms of quality of the exam, anxiety procedure-related and financial toxicity.
详细描述
The aim of this study is to evaluate the effectiveness, in daily clinical practice, of a tele-consultation procedure (defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy) with the goal of:
- improving adherence to methods and timing for the correct intake of the intestinal preparation by patients undergoing elective colonoscopy;
- assessing whether the tele-consultation can reduce anxiety and procedure-related stress, promoting a better emotional state in patients undergoing colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for outpatient pancolonoscopy:
- •for diagnostic purposes;
- •for screening purposes;
- •for post-polypectomy follow-up;
- •of both genders;
- •of all ethnicities;
排除标准
- •Patients under 18 years of age or over 80 years of age;
- •Patients on waiting lists with SHORT priority: the procedure to be provided within a short time (no more than 10 days);
- •Patients included in GOM pathways who undergo colonoscopy within 10 days;
- •Pregnancy;
- •Presence of known contraindications to bowel preparation;
- •Presence of known contraindications to performing pancolonoscopy;
- •Patients who have undergone colonic resection and/or have a colostomy/ileostomy;
- •Patients with cognitive impairments;
- •Patients declared legally incompetent or unable to understand and make decisions;
- •Patients unable to provide informed consent.
研究组 & 干预措施
nurse tele-consultation arm
Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure.
干预措施: Tele-consultation (Other)
Standard arm
结局指标
主要结局
H.A.D.S. (Hospital Anxiety and Depression Scale)
时间窗: baseline, before colonoscopy up to 12 months
Compare the quality of the emotional state between the sample of patients who received tele-consultation (INTERVENTION Group) and those who did not receive tele-consultation (CONTROL Group) based on the H.A.D.S. score (Hospital Anxiety and Depression Scale).The scale consists of 14 items, with 7 questions related to anxiety and 7 related to depression. Each item is rated on a 4-point scale (from 0=not at all to 3= most of the time). The total score for each section (anxiety and depression) can range from 0 to 21, and then the scores from both sections are combined for a total score ranging from 0 to 42. The minimun score is 0-7 that means normal (little to no anxiety or depression). The maximum score is 15-21 that means severe (significant anxiety or depression).
Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)
时间窗: at the end of colonoscopy up to 12 months
Compare the quality of the colonoscopy between patients who received tele-consultation (INTERVENTION Group) and those who did not receive tele-consultation (CONTROL Group) based on the BBPS score (BOSTON BOWEL PREPARATION SCORE). The BBPS score ranges from 0 to 9 based on intestinal preaparation in cecum, colon and rectum. Each section is scored on a scale of 0 to 3 (0= unprepared to 3= excellent). The total BBPS score is the sum of the scores from the three sections (score 0 to 5=Poor preparation; score 6 to 7= fair preparation; score 8 to 9=good preparation). A higher score indicates better bowel preparation, which is ideal for a successful colonoscopy.
次要结局
- Financial Toxicity (FT) using the "PROFFIT questionnaire"(baseline (before colonoscopy) up to 12 months)
- Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)(at the end of colonoscopy up to 12 months)
- Rate of cecal intubation(at the end of colonoscopy up to 12 months)