- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552792
Impact of Hand Rub Placement on Patient Trust and Disease Stigma
The Impact of Hand Rub Placement on Hand Hygiene Sequence, Patient Trust, and Disease Stigma: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale:
Patients with visible non-communicable diseases, such as psoriasis, often experience high levels of disease-related stigma and are highly sensitive to physician behaviors. Although hand hygiene is a cornerstone of infection control, executing it in certain clinical scenarios may be misinterpreted by patients as the physician's "fear" or "disgust" toward their condition. This misinterpretation can exacerbate their psychological burden and impair the doctor-patient relationship. Environmental engineering theories suggest that micro-modifications to physical hospital spaces can significantly alter medical behavior patterns (such as sitting versus standing during consultations) without relying on resource-intensive training or administrative supervision.Study Design and Methodology:
This is a single-center, double-blind, randomized controlled deception trial conducted in an outpatient dermatology setting. The core intervention involves manipulating the spatial location of the hand sanitizer in the consultation room through randomized assignment to determine its causal effect on physician behavior and subsequent patient psychological outcomes. To minimize the Hawthorne effect and behavioral bias, a double-blind deception mechanism is employed. Physicians are informed that the study is simply for medical students to observe general consultation workflows, while patients are told they are participating in a routine outpatient service satisfaction survey. The true nature of the environmental intervention and its behavioral focus is concealed until a debriefing session at the conclusion of the study.Observations and Assessments:
During the study, trained observers will discreetly record the physicians' hand hygiene patterns in the consultation room. After the consultation concludes, participating psoriasis patients will be guided to an independent area to complete an anonymous electronic questionnaire (taking approximately 10 minutes).The primary psychological outcomes assessed include:Doctor-patient trust, measured by the 11-item Trust in Physician Scale (TPS).Intensity of disease stigma, measured by the 27-item Chinese version of the Feelings of Stigma Questionnaire (FSQ).Secondary outcomes include overall patient satisfaction evaluated across five dimensions, and the documentation of physician hand hygiene timing patterns under different environmental layouts.Statistical Analysis:
Analyses will utilize a prospectively defined dataset framework. Multivariate linear regression will be used to analyze the psychological impact pathways on trust and stigma, adjusting for demographic variables. Generalized estimating equations (GEE) and mixed linear models will be applied for sensitivity analyses to account for the correlation of multiple observations from the same physician.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Juan Du, MD
- Phone Number: +86-13601821207
- Email: dujuan@huashan.org.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For Patients:
- Aged 18 years or older.
- Diagnosed with psoriasis and receiving treatment at the designated psoriasis specialty outpatient clinic during the study period.
- Legally capable of signing the informed consent form and cognitively able to understand and complete the questionnaire (independently or with assistance from family members).
For Physicians:
- Hold a registered practicing qualification in the Dermatology Department of Huashan Hospital Pudong Branch and are qualified for independent outpatient consultations.
- Scheduled to continuously undertake outpatient work in the designated consultation rooms during the study period.
- Voluntarily sign the informed consent form for behavioral observation.
Exclusion Criteria:
For Patients:
- Severe visual, hearing, or speech impairments leading to basic doctor-patient communication barriers.
- Diagnosed with psychiatric disorders (e.g., schizophrenia, severe depression) that, as assessed by a specialist, may interfere with the authenticity of the questionnaire responses.
- Presenting with a clinical state requiring emergency treatment during the visit, such as acute infection of skin lesions or generalized pustules.
For Physicians:
- Non-permanent practicing staff of the hospital, such as visiting physicians or rotating medical students.
- Unable to independently perform hand hygiene procedures due to physical/limb dysfunction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Distant Placement Group
In this experimental arm, the hand rub dispenser is placed at a distant position, greater than 1 meter (approx.
3.3 feet) away from the physician (e.g., on a sink), before the outpatient consultation begins.
|
The alcohol-based hand rub dispenser is relocated to a distant position in the consultation room, greater than 1 meter (approx.
3.3 feet) away from the physician (e.g., on a sink).
This environmental modification is designed to prompt physicians to perform hand hygiene after the patient departs ("invisible hand hygiene"), aiming to improve patient trust and reduce perceived disease-related stigma.
|
|
Active Comparator: Conventional Placement Group
In this active comparator arm, the hand rub dispenser is placed in the conventional position, less than or equal to 0.3 meters (approx. 1 foot) away from the physician (e.g., to the left of the computer), before the outpatient consultation begins.
|
The alcohol-based hand rub dispenser is placed in the conventional, standard position in the consultation room, which is less than or equal to 0.3 meters (approx. 1 foot) away from the physician (e.g., to the left of the computer).
This facilitates standard hand hygiene immediately after patient contact ("visible hand hygiene").
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Invisible Hand Hygiene Events
Time Frame: Assessed during the outpatient consultation (average 10-15 minutes per consultation).
|
Hand hygiene behavior was observed and categorized into "visible hand hygiene" (immediate post-contact cleansing before patient departure) and "invisible hand hygiene" (cleansing after patient departure).
A positive outcome is defined as handwashing occurring after the patient leaves (invisible hand hygiene).
The outcome is reported as the proportion of consultations where invisible hand hygiene occurred.
|
Assessed during the outpatient consultation (average 10-15 minutes per consultation).
|
|
Patient Trust in Physician Scale (TPS) Score
Time Frame: Assessed immediately after the outpatient consultation.
|
Patient trust was measured using the 10-item Trust in Physician Scale (TPS), a validated tool using a 5-point Likert scale to assess trust in the physician's competence, communication, and prioritization of patient interests.
Results are expressed as percentages of total possible scores (range 0-100%).
Higher scores indicate a higher level of trust in the physician.
|
Assessed immediately after the outpatient consultation.
|
|
Feelings of Stigma Questionnaire (FSQ) Score
Time Frame: Assessed immediately after the outpatient consultation.
|
Perceived disease stigma was measured using the 28-item modified Feelings of Stigma Questionnaire (FSQ), which uses a 6-point scale to assess subjective experiences of stigma across domains including self-stigma, social exclusion, privacy management, and emotional impact.
Results are expressed as percentages of total possible scores (range 0-100%).
Higher scores indicate higher levels of perceived disease stigma.
|
Assessed immediately after the outpatient consultation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Score
Time Frame: Assessed immediately after the outpatient consultation.
|
Exploratory outcome evaluating patient satisfaction with the consultation process.
This covers domains including private consultations, service attitude, disease/treatment explanations, follow-up arrangements, and privacy protection.
Assessed via 5-point Likert scales, where higher scores indicate greater patient satisfaction.
|
Assessed immediately after the outpatient consultation.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091.
- Ginsburg IH, Link BG. Feelings of stigmatization in patients with psoriasis. J Am Acad Dermatol. 1989 Jan;20(1):53-63. doi: 10.1016/s0190-9622(89)70007-4.
- Puhl R, Suh Y. Health Consequences of Weight Stigma: Implications for Obesity Prevention and Treatment. Curr Obes Rep. 2015 Jun;4(2):182-90. doi: 10.1007/s13679-015-0153-z.
- Reid H, Smith R, Williamson W, Baldock J, Caterson J, Kluzek S, Jones N, Copeland R. Use of the behaviour change wheel to improve everyday person-centred conversations on physical activity across healthcare. BMC Public Health. 2022 Sep 20;22(1):1784. doi: 10.1186/s12889-022-14178-6.
- Speight J, Holmes-Truscott E, Garza M, Scibilia R, Wagner S, Kato A, Pedrero V, Deschenes S, Guzman SJ, Joiner KL, Liu S, Willaing I, Babbott KM, Cleal B, Dickinson JK, Halliday JA, Morrissey EC, Nefs G, O'Donnell S, Serlachius A, Winterdijk P, Alzubaidi H, Arifin B, Cambron-Kopco L, Santa Ana C, Davidsen E, de Groot M, de Wit M, Deroze P, Haack S, Holt RIG, Jensen W, Khunti K, Kragelund Nielsen K, Lathia T, Lee CJ, McNulty B, Naranjo D, Pearl RL, Prinjha S, Puhl RM, Sabidi A, Selvan C, Sethi J, Seyam M, Sturt J, Subramaniam M, Terkildsen Maindal H, Valentine V, Vallis M, Skinner TC. Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations. Lancet Diabetes Endocrinol. 2024 Jan;12(1):61-82. doi: 10.1016/S2213-8587(23)00347-9.
- Sant'Anna A, Vilhelmsson A, Wolf A. Nudging healthcare professionals in clinical settings: a scoping review of the literature. BMC Health Serv Res. 2021 Jun 2;21(1):543. doi: 10.1186/s12913-021-06496-z.
- Iyer R, Park D, Kim J, Newman C, Young A, Sumarsono A. Effect of chair placement on physicians' behavior and patients' satisfaction: randomized deception trial. BMJ. 2023 Dec 15;383:e076309. doi: 10.1136/bmj-2023-076309.
- Anderson J, Fenton K. HIV related stigma: a dangerous roadblock. BMJ. 2022 Dec 12;379:o2989. doi: 10.1136/bmj.o2989. No abstract available.
- Kahn MW. Etiquette-based medicine. N Engl J Med. 2008 May 8;358(19):1988-9. doi: 10.1056/NEJMp0801863. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2025-1371
- 24ZR1407800 (Other Grant/Funding Number: Natural Science Foundation of Shanghai)
- C2025212 (Other Grant/Funding Number: Shanghai Municipal Educational Science Research Project)
- HSWH202403 (Other Grant/Funding Number: Huashan Hospital, Fudan University)
- HSWH202505 (Other Grant/Funding Number: Huashan Hospital, Fudan University)
- HSWH202513 (Other Grant/Funding Number: Huashan Hospital, Fudan University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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