Post-discharge Cessation for Smoking Patients

Smoking Cessation Clinical Trial

Official title:

Nurse-led Post-discharge Cessation Support for Smoking Patients Using Mobile-based Intervention: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430789
• Other study ID #: SC discharge
• Secondary ID: HKU Clinical Tri
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: Man Ping Wang, PhD
• Phone: +852 3917 6636
• Email: mpwang[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals.

Description:

Most smoking patients continue to smoke (76.1%) after being discharged from hospitals. Post-discharge smoking cessation (SC) support is one of the most cost-effective treatments. Hospitalisation offers a teachable moment to motivate patients to engage in post-discharge intervention, particularly those suffering from smoking-related diseases. Behavioral and psychosocial support increases abstinence in patients. Current clinical guidelines in the US (USPSTF) and UK (NICE) recommend health care professionals to provide brief SC support to patients using a brief advice model such as the 5As (Ask, Assess, Advice, Assist, Arrange) and further motivational 5Rs interventions (Relevance, Risks, Rewards, Roadblocks, and Repetition) if needed for those not having quit attempts. A key trial found that providing discharged patients with such proactive and sustained care as free SC medication, telephone calls to promote quitting, and additional counselling through clinic referrals increased 6-months validated quitting. Trained patient navigators providing patients in hospital primary clinics with tailored individual advice with medication and counselling referrals were found to be effective at improving 12-months quitting. Previous trials also showed connecting community smokers or smokers who visited emergency departments to existing SC services increased validated quitting at 6-months. Recent advances in mobile phone technology allow incorporating such innovations to improve the cost-effectiveness of post-discharge smoking cessation services. Mobile phones are increasingly used for monitoring and delivering personalised health treatments (mHealth). Regular text messaging was found to increased 6-months validated abstinence in general smokers, although the study was limited to pre-defined messages and interactions. A previous study reported an automated interactive voice response to be favored by patients and to increase abstinence. A text-based programme was tested in a Chinese population, and previous study found the delivery of interactive chat-based SC support via IM apps to be effective in increasing quitting. Chat-based SC interventions can provide real-time, personalised behavioral support and referrals to SC services. Mobile health is also part of the World Health Organization's strategies to combat smoking. Leveraging the success of previous trials in inpatients and a chat-based trial using IM to deliver behavioral support to community smokers, This study proposes to refine the 5As cessation model by incorporating a mobile phone-based intervention for patients recently discharged from hospitals. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Active referral of community smokers to smoking cessation services increases service use and quitting but smoking patients were not referred for sustained cessation service in hospitals in Hong Kong. The effect of mobile phone-based intervention with active referral to link discharged patients for standard smoking cessation service remains unclear. Therefore, This study proposes to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals in Hong Kong.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 770
• Est. completion date: September 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Smokers who are hospitalised or waiting for discharge in Hong Kong

2. Smoke cigarettes or alternative tobacco products (e.g. electronic cigarettes or heated tobacco products) daily at 1 month prior to hospitalisation

3. Have a smartphone with an IM app (WhatsApp or WeChat) and experience in using the app

4. Hong Kong adult residents (18+) able to communicate in Chinese (Cantonese or Mandarin)

Exclusion Criteria:

1. Smokers not mentally fit for communication (e.g. psychiatry patients)

2. Smokers currently using SC medication or other SC services

3. Smokers hospitalised for more than 1 month

4. Perceived difficulty to use IM after discharge

Related Conditions & MeSH terms

• Mobile Health
• Post-discharge
• Smoking Cessation

Intervention

Behavioral:
• 5As brief advice
Participants will receive brief face-to-face advice following a 5As model at baseline: Ask: Smoking patients will be asked about their smoking status. Advise: Smoking patients will be advised to quit in a clear and personalised manner, with a focus on smoking-related diseases. Assess: Smoking patients will be assessed for their readiness to quit by assessing their self-efficacy and perceived importance. Assist: Those who are ready to quit will be assisted in setting a quit plan. Arrange: Refer to smoking cessation services.
• Self-help e-booklet
A 12-page generic self-help smoking cessation e-booklet via IM apps, including: Highlights of the absolute risk of death due to smoking; Smoking and diseases management; Ten horrible pictorial warnings of health consequences of smoking and second-hand smoking; Benefits of quitting; Methods to quit and handle. withdrawal symptoms.
• Nurse-led mHealth intervention
Participants will receive real-time mHealth behaviour and psychosocial support for 12 weeks after baseline through IM apps. mHealth intervention consists of two main parts: regular instant messaging on smoking cessation and personalized real-time mHealth chatting on smoking and disease (including active referral to smoking cessation service)
• Regular intervention
Participants will receive text messages using IM app with content on general health and reminding the importance of participating in the follow-up surveys and biochemical validation for quitting.

Locations

Country	Name	City	State
China	School of Nursing, The University of Hong Kong	Hong Kong	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
The University of Hong Kong	Kwong Wah Hospital, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically-validated abstinence	Defined by exhaled carbon monoxide < 4 parts per million (ppm) and salivary cotinine < 30 ng/ml	6-month after baseline
Primary	Biochemically-validated abstinence	Defined by exhaled carbon monoxide < 4 parts per million (ppm) and salivary cotinine < 30 ng/ml	12-month after baseline
Secondary	Self-reported past 7-day abstinence	Being completely smoke-free in the past 7 days	6-month after baseline
Secondary	Self-reported past 7-day abstinence	Being completely smoke-free in the past 7 days	12-month after baseline
Secondary	24-weeks continuous abstinence	Being completely smoke-free in the past 24 weeks	6-month after baseline
Secondary	24-weeks continuous abstinence	Being completely smoke-free in the past 24 weeks	12-month after baseline
Secondary	Intention to quit	A single item will measure if smokers plan to quit smoking in 30 days, with response of yes or no	6-month after baseline
Secondary	Intention to quit	A single item will measure if smokers plan to quit smoking in 30 days, with response of yes or no	12-month after baseline
Secondary	Number of quit attempt	Defined by abstinence for at least 24 hours	6-month after baseline
Secondary	Number of quit attempt	Defined by abstinence for at least 24 hours	12-month after baseline
Secondary	Smoking reduction	Defined by at least 50% self-reported reduction in baseline daily number of cigarettes	6-month after baseline
Secondary	Smoking reduction	Defined by at least 50% self-reported reduction in baseline daily number of cigarettes	12-month after baseline
Secondary	Nicotine dependence level	Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)	6-month after baseline
Secondary	Nicotine dependence level	Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)	12-month after baseline
Secondary	Smoking cessation service use	Any access to a smoking cessation service	6-month after baseline
Secondary	Smoking cessation service use	Any access to a smoking cessation service	12-month after baseline