Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University Shuang Ho Hospital

About this trial

This study is a prospective randomized controlled trial that aims to enroll 158 patients diagnosed with chronic hypertrophic rhinitis who are candidates for inferior turbinate surgery. Participants will be randomly assigned to either the "standard group" or the "PDA group." The standard group will receive conventional shared decision-making (SDM) explanations using verbal and visual aids, while the PDA group will additionally receive a printed patient decision aid (PDA) to assist in evaluating the pros and cons of each surgical option. The study will assess patients' decision certainty and decision regret using the SURE scale and the Decision Regret Scale (DRS), respectively, administered before surgery and one month postoperatively. Surgical satisfaction and outcomes will also be evaluated using pre- and postoperative symptom questionnaires. All data will be collected and analyzed by blinded outcome assessors to ensure objectivity. This study involves no invasive procedures and is classified as a low-risk behavioral study. The primary aim is to optimize clinical decision-making processes for patients with chronic hypertrophic rhinitis considering surgical intervention in the otolaryngology setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with chronic hypertrophic rhinitis.

Outpatients or inpatients scheduled to undergo surgical intervention.

Aged 18 years or older and able to communicate in Chinese.

Disqualifiers

Presence of other structural nasal pathologies (e.g., nasal polyps, tumors).

Patients undergoing emergency surgery.

Individuals unable to live independently or fully comprehend the questionnaire content.

Individuals unable to complete the questionnaires.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient decision aid

    Other intervention

    The Patient Decision aid used in this project is a tool designed to facilitate shared decision making in patients with hypertrophic rhinitis. It is intended to complement counseling with health professionals and help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of five surgical interventions, knowledge of treatment outcomes, and by clarifying personal values.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Patient decision aidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Decision conflicts

Mean score of decisional conflict scale by SURE test using a five-item scale with 5 questions: 1 = agree strongly, 2 = agree, 3 = neutral, 4 = disagree, 5 = disagree strongly.

Time frame
On the day 1 of admission

Secondary outcomes

1

Decision regret

Mean score of a decision regret scale by DRS test using a five-item scale with 6 questions: 1 = agree strongly, 2 = agree, 3 = neutral, 4 = disagree, 5 = disagree strongly. Two questions are reverse-worded and should be scored in reverse.

Time frame
A month after surgical intervention

Other outcomes

1

Visual Analogue Scale for Rhinitis Symptom Severity

Mean score of a patient-rated visual analogue scale assessing overall rhinitis symptom severity before surgery and after surgery. The response anchors are presented as scores on a line: abscent symptoms = 0, mild symptoms= 1-3, moderate symptoms= 4-6, severe symptoms= 7-10. Functional-impairment descriptors are provided to help calibration.

Time frame
On the day 1 of admission and A month after surgical intervention
2

Symptom Impact Frequency on Daily Life

Mean score of a single-item frequency measure capturing how often nasal symptoms impact daily life, recorded as duration: longer than 4 weeks or shorter than 4 weeks. Number of days per week affected is also asked.

Time frame
On the day 1 of admission and a month after surgical intervention
3

Nasal Obstruction Symptom Evaluation

Mean score of a five-item patient-reported outcome assessing the impact of nasal obstruction on quality of life over the past month with 5 qeustions. Each item is rated on a 0-4 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, and 4 = unbearable symptoms. Symptoms included: nasal blockage, nasal congestion or swelling, trouble breathing through the nose, trouble sleeping or poor sleep, and inadequate nasal airflow during exercise or activity.

Time frame
On the day 1 of admission and a month after surgical intervention
4

24-hour Reflective Total Nasal Symptom Score

Mean score of a four-item composite reflecting nasal symptom severity over the past 24 hours with 4 questions, rated per symptom on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. Symptoms included: nasal congestion, rhinorrhea or postnasal drip, nasal or throat itch or chronic cough, and sneezing.

Time frame
On the day 1 of admission and a month after surgical intervention

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