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

NCT ID: NCT03995381

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Haemostatic Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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DAs group

Shared decision making using decision aids

Group Type EXPERIMENTAL

Decision aids

Intervention Type OTHER

Shared decision making with decision aids

Control group

Standard oral explanation guided with booklets

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decision aids

Shared decision making with decision aids

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shuang Ho Hospital, Taipei Medical University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Yi-Chun Huang

Role: CONTACT

886-2-88490088 ext. 1304

Facility Contacts

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Yi-Chun Huang

Role: primary

886-2-22490088 ext. 1304

Other Identifiers

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N201902036

Identifier Type: -

Identifier Source: org_study_id

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