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

NCT03995381 | Unknown

• 1 other identifier: N201902036
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haemostatic Adverse Reaction

Keywords

Haemostasis

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  Total score of decisional conflict scale

  1 hour before Angiography

Study Arms (2)

DAs group

EXPERIMENTAL

Shared decision making using decision aids

Other: Decision aids

Control group

NO INTERVENTION

Standard oral explanation guided with booklets

Interventions

Decision aids OTHER

Shared decision making with decision aids

DAs group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who needs an angiographic examination or treatment.
• Patients with angiographic indications
• Patients who were able to give consent and complete the interview

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, Taiwan

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Yi-Chun Huang

CONTACT

886-2-88490088; 12020@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: September 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)