Trial Outcomes & Findings for Randomized Controlled Trial (RCT) of a Motivational Decision Support System (NCT NCT02086162)

NCT ID: NCT02086162

Last Updated: 2018-11-29

Results Overview

Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.

Recruitment status

COMPLETED

Study phase

Target enrollment

184 participants

Primary outcome timeframe

6 months

Results posted on

2018-11-29

Participant Flow

After participating in an informed consent process, 184 subjects were assessed for eligibility. 11 were ineligible and 11 declined or were unable to proceed with the study for other reasons. 162 were randomized and proceeded to receive an intervention.

Participant milestones

Participant milestones
Measure	Let's Talk About Smoking These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	National Cancer Institute (NCI) Computerized Education The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Overall Study STARTED	78	84
Overall Study COMPLETED	68	77
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Let's Talk About Smoking These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	National Cancer Institute (NCI) Computerized Education The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Overall Study Withdrawal by Subject	4	4
Overall Study moved	1	1
Overall Study Lost to Follow-up	4	2
Overall Study Death	1	0

Baseline Characteristics

Randomized Controlled Trial (RCT) of a Motivational Decision Support System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Intervention n=78 Participants Web-based motivational decision support system	Educational Intervention n=84 Participants Computerized version of the National Cancer Institute (NCI) Educational Pamphlet NCI Education	Total n=162 Participants Total of all reporting groups
Age, Continuous	47.62 years STANDARD_DEVIATION 11.29 • n=5 Participants	44.32 years STANDARD_DEVIATION 11.18 • n=7 Participants	45.91 years STANDARD_DEVIATION 11.32 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	59 Participants n=7 Participants	108 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	84 participants n=7 Participants	162 participants n=5 Participants
Brief Psychiatric Rating Scale	41.79 units on a scale STANDARD_DEVIATION 11.95 • n=5 Participants	40.38 units on a scale STANDARD_DEVIATION 10.32 • n=7 Participants	41.06 units on a scale STANDARD_DEVIATION 11.11 • n=5 Participants
Positive and Negative Affect Schedule - Positive	22.36 units on a scale STANDARD_DEVIATION 8.66 • n=5 Participants	22.31 units on a scale STANDARD_DEVIATION 8.48 • n=7 Participants	22.33 units on a scale STANDARD_DEVIATION 8.54 • n=5 Participants
Positive and Negative Affect Schedule - Negative	12.04 units on a scale STANDARD_DEVIATION 9.09 • n=5 Participants	12.06 units on a scale STANDARD_DEVIATION 9.45 • n=7 Participants	12.05 units on a scale STANDARD_DEVIATION 9.25 • n=5 Participants
Cognition battery Z Scores	-.029 units on a scale STANDARD_DEVIATION 0.68 • n=5 Participants	.016 units on a scale STANDARD_DEVIATION 0.70 • n=7 Participants	-.006 units on a scale STANDARD_DEVIATION 0.69 • n=5 Participants
Cigarettes per day	14.48 cigarettes STANDARD_DEVIATION 9.62 • n=5 Participants	14.64 cigarettes STANDARD_DEVIATION 11.3 • n=7 Participants	14.56 cigarettes STANDARD_DEVIATION 10.49 • n=5 Participants
Fagerstrom dependence score	5.03 units on a scale STANDARD_DEVIATION 2.19 • n=5 Participants	5.30 units on a scale STANDARD_DEVIATION 1.80 • n=7 Participants	5.16 units on a scale STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Let's Talk About Smoking n=78 Participants These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	National Cancer Institute (NCI) Computerized Education n=84 Participants The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Number of Subjects That Initiated Cessation Treatment	27 participants	36 participants

SECONDARY outcome

Timeframe: 6 months

Biologically confirmed abstinence: we will confirm 7-day point prevalence abstinence at 6 month assessments (self-reported abstinence without any smoking, "not even a puff," for the past 7 days,) with expired carbon monoxide (reading ≤9).

Outcome measures

Outcome measures
Measure	Let's Talk About Smoking n=78 Participants These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	National Cancer Institute (NCI) Computerized Education n=84 Participants The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Number of Subjects With Confirmed Abstinence	1 participants	6 participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Let's Talk About Smoking n=78 Participants These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	National Cancer Institute (NCI) Computerized Education n=84 Participants The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence	13 Participants	11 Participants

Adverse Events

Behavioral Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Behavioral Intervention n=78 participants at risk These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	Educational Intervention n=84 participants at risk The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Cardiac disorders Death	1.3% 1/78 • Number of events 1 • 6 months	0.00% 0/84 • 6 months

Other adverse events

Other adverse events
Measure	Behavioral Intervention n=78 participants at risk These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior \[98\], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) \[140, 141\]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment \[142-144\], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment.	Educational Intervention n=84 participants at risk The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition \[162\] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc).
Psychiatric disorders Suicidal ideation	0.00% 0/78 • 6 months	1.2% 1/84 • Number of events 1 • 6 months

Additional Information

Dr. Mary F. Brunette

Dartmouth-Hitchcock

Phone: 603-229-5419

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place