Clinical trial NCT05430789: Post-discharge Cessation for Smoking Patients
Official title: Nurse-led Post-discharge Cessation Support for Smoking Patients Using Mobile-based Intervention: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Post-discharge
Mobile Health
Keywords: Behavioral change techniques
Smoking cessation
Mobile health technology
Nurse-led intervention
Post-discharge
Discharged patients
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Princess Margaret Hospital, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
name: Kwong Wah Hospital
First posted: 2022-06-24
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically-validated abstinence
timeFrame: 6-month after baseline
measure: Biochemically-validated abstinence
timeFrame: 12-month after baseline
Secondary outcomes:
measure: Self-reported past 7-day abstinence
timeFrame: 6-month after baseline
measure: Self-reported past 7-day abstinence
timeFrame: 12-month after baseline
measure: 24-weeks continuous abstinence
timeFrame: 6-month after baseline
measure: 24-weeks continuous abstinence
timeFrame: 12-month after baseline
measure: Intention to quit
timeFrame: 6-month after baseline
measure: Intention to quit
timeFrame: 12-month after baseline
measure: Number of quit attempt
timeFrame: 6-month after baseline
measure: Number of quit attempt
timeFrame: 12-month after baseline
measure: Smoking reduction
timeFrame: 6-month after baseline
measure: Smoking reduction
timeFrame: 12-month after baseline
measure: Nicotine dependence level
timeFrame: 6-month after baseline
measure: Nicotine dependence level
timeFrame: 12-month after baseline
measure: Smoking cessation service use
timeFrame: 6-month after baseline
measure: Smoking cessation service use
timeFrame: 12-month after baseline
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Nursing, The University of Hong Kong
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: