Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis

Haemostatic Adverse Reaction Clinical Trial

— N201902036  

Official title:

Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03995381
• Other study ID #: N201902036
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2019
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Yi-Chun Huang
• Phone: 886-2-88490088
• Email: 12020[@]s.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vascular closure device, hemostatic bandage and manual compression can achieve hemostasis after angiographic examination. These three methods of hemostasis changed the rate of hemostasis, early ambulation, hematoma , hemostasis failure rate, and expense. Therefore, shared decision making (SDM) is necessary to aid patients to choose hemostasis.The investigators have developed a decision aids (DA) and planned a randomized controlled trial (RCT) to evaluate its impact on angiographic patients. The measurements include a battery of interview-based questionnaires and evaluations of decision conflicts. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and choice conflicts.during and after thier Hemostasis procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who needs an angiographic examination or treatment.

• Patients with angiographic indications

• Patients who were able to give consent and complete the interview

Exclusion Criteria:

• The angiographic procedure uses patients with a catheter size more than 7fr.

• Patients in critical situations requiring urgent treatment

• Patients had cognitive impairment

• Patients were physically unfit to be interviewed

• Patients were non-Mandarin or -Taiwanese

Related Conditions & MeSH terms

• Haemostatic Adverse Reaction

Intervention

Other:
• Decision aids
Shared decision making with decision aids

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital, Taipei Medical University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	Total score of decisional conflict scale	1 hour before Angiography