Trial Outcomes & Findings for Telephone Counseling for Tobacco Cessation (NCT NCT01489579)

Results Overview

The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

192 participants

Primary outcome timeframe

3 months

Results posted on

2019-03-18

Participant Flow

A total of 347 patients were identified as eligible for study participation study personnel contacted the patient by telephone approximately 2 weeks prior to her or his scheduled SOC encounter to describe the study and obtain verbal consent for enrollment. 192 were consented.

Seventy-two subjects did not obtain scheduled laboratory data or have contact with a clinical pharmacist during the study time period resulting in 120 subjects, 56 and 64 in the control and intervention groups, respectively, enrolled in the study.

Participant milestones

Participant milestones
Measure	Usual Care Group Pharmacists randomized to Usual Care will continue to provide interventions/procedures according to usual care practices. Interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists randomized to Usual Care were asked to continue their current approach for tobacco cessation	BST Counseling Group The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources
Overall Study STARTED	56	64
Overall Study COMPLETED	47	57
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telephone Counseling for Tobacco Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BST Counseling Group n=64 Participants The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout. Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service: The patients in the BST counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counse	Usual Care Group n=56 Participants Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations. Usual Care: Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendatio	Total n=120 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 8.1 • n=5 Participants	64.6 years STANDARD_DEVIATION 9.4 • n=7 Participants	65.7 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	56 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Reported not smoking at follow up survey

The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact

Outcome measures

Outcome measures
Measure	BST Counseling Group n=57 Participants The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources	Usual Care Group n=47 Participants Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
The Percentage of Self-reported Tobacco Cessation Attempts Between Groups	8 participants	5 participants

SECONDARY outcome

Timeframe: 3 months

Population: Three control patients reported participation in the Colorado quitline

Information on COQL participation was obtained from a prevention department within KPCO that tracks these data. Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact.

Outcome measures

Outcome measures
Measure	BST Counseling Group n=64 Participants The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources	Usual Care Group n=56 Participants Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 months

Population: The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco

The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco

Outcome measures

Outcome measures
Measure	BST Counseling Group n=64 Participants The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources	Usual Care Group n=56 Participants Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact. Medications include nicotine replacement therapy, bupropion, and varenicline

Outcome measures

Outcome measures
Measure	BST Counseling Group n=64 Participants The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources	Usual Care Group n=56 Participants Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.	7 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 months

The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact

Outcome measures

Outcome measures
Measure	BST Counseling Group n=57 Participants The patients in the Brief, Structured, Telephone, BST, counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources	Usual Care Group n=47 Participants Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey	8 Participants	5 Participants

Adverse Events

BST Counseling Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alicia Cymbala

Kaiser Permanente

Phone: 303-972-5384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place