Perioperative Smoking Cessation Interventions

NCT03222908 | Terminated

• 1 other identifier: Pro00076125
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.

Conditions

Smoking Cessation; Perioperative/Postoperative Complications

Keywords

Behavior; Perioperative/Postoperative Complications; contract agreement; implementation intentions; precommitment; smoking cessation

Outcome Measures

Primary Outcomes (2)

• Smoking Cessation

  Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test

  day of surgery

• Smoking Cessation

  Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test

  day of first postoperative appointment

Secondary Outcomes (1)

• Postoperative Complications

  30 days postoperatively

Study Arms (3)

Control: Prescriptive Advice

NO INTERVENTION

Amenable patients will be enrolled into the study, their intervention will be current standard of care smoking cessation counseling by their surgeon, they will undergo 3 urine tests and a chart review for outcomes.

Intervention1: Contract Agreement

EXPERIMENTAL

Amenable patients will be enrolled into the study, their intervention will be a smoking cessation contract with their surgeon, they will undergo 3 urine tests and a chart review for outcomes.

Behavioral: Intervention1: Contract Agreement

Intervention2: Implementation Intentions

EXPERIMENTAL

Amenable patients will be enrolled into the study, their intervention will be a worksheet to fill out with their smoking cessation implementation intentions that will be signed by patient and surgeon, they will undergo 3 urine tests and a chart review for outcomes.

Behavioral: Intervention2: Implementation Intentions

Interventions

Intervention1: Contract Agreement BEHAVIORAL

Smoking Cessation Contract

Intervention1: Contract Agreement

Intervention2: Implementation Intentions BEHAVIORAL

Smoking Cessation Contract with worksheet for implementation intentions

Intervention2: Implementation Intentions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active tobacco use
• preoperative appointment for an operation within 6 weeks

You may not qualify if:

• active enrollment in tobacco cessation program

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Postoperative Complications; Behavior

Condition Hierarchy (Ancestors)

Health Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher R Mantyh, MD

  DUKE DEPARTMENT OF SURGERY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: August 15, 2017
• Primary Completion: June 20, 2018
• Study Completion: July 30, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)