## Protocol Section
### Identification Module
**NCT ID:** NCT01489579

**Brief Title:** Telephone Counseling for Tobacco Cessation

**Official Title:** Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service

#### Organization Study ID Info
**ID:** CO-11-1660
#### Organization
**Class:** OTHER
**Full Name:** Kaiser Permanente
### Status Module
#### Completion Date
**Date:** 2015-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2018-12-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-03-18

**Type:** ACTUAL

**Results First Submit Date:** 2016-12-07

**Results First Submit QC Date:** 2018-12-04

#### Start Date
**Date:** 2011-11

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2011-12-09
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-08
**Study First Submit QC Date:** 2011-12-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kaiser Permanente

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine whether giving more structured information to patients over the phone about quitting tobacco helps to increase the chance that they will try to quit. The results of this study will help provide direction in developing a more standard way of helping patients to quit.

Study Hypothesis:

Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy specialists will significantly increase the percentage of self-reported tobacco cessation attempts compared to usual care among patients enrolled in a cardiovascular risk reduction program.

**Detailed Description:** While physician-delivered care may have the greatest impact on tobacco abstinence rates, recent data indicate that other health care providers such as nurses and pharmacists improve tobacco abstinence rates more than self-help and/or no intervention.5 Thus, pharmacists continue to expand their clinical practice areas to include smoking cessation interventions. A meta-analysis of studies involving pharmacist-delivered smoking cessation services found quit rates at 6 to12 months follow-up ranged from 14% to16%.6 The results of this meta-analysis demonstrate that pharmacists can successfully deliver tobacco-cessation interventions and the evidence strongly suggests they are effective in helping increase tobacco cessation rates. Proactive telephone counseling can be more effective at increasing tobacco abstinence rates than self-help or no intervention.5 Telephone counseling is an effective system to help increase tobacco abstinence rates for a variety of reasons. From the tobacco user's standpoint, there are no transportation inconveniences and fewer scheduling conflicts. In addition, receiving counseling in the privacy of one's own home provides treatment access to individuals who are less willing to seek out counseling. At Kaiser Permanente Colorado (KPCO), members with a history of CVD are enrolled in the Clinical Pharmacy Cardiac Risk Service (CPCRS). The CPCRS is a clinical pharmacy specialist-managed, physician-directed program which provides secondary prevention care to over 14,000 patients. Clinical care includes evaluating and treatment of major cardiovascular risk factors, including tobacco use, for members. Currently, CPCRS has no standard of care with regard to addressing tobacco use. Clinical pharmacy specialists working in CPCRS deliver tobacco cessation advice at their own discretion, through various methods. The purpose of this pilot study is to determine whether brief, structured, telephone tobacco cessation counseling delivered by a clinical pharmacy specialist increases the number of smoking cessation attempts compared to usual care.

### Conditions Module

**Conditions:**

- Tobacco Use Cessation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 192

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients in the Brief, structured, telephone tobacco cessation, BST, counseling group, will receive tobacco cessation counseling, intervention, 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.

**Intervention Names:**

- Behavioral: Telephone Counseling for Tobacco Cessation

**Label:** BST counseling group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Behavioral: Usual Care

**Label:** Usual care group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BST counseling group

**Description:** 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 ("Ready to quit" patient handout)

**Name:** Telephone Counseling for Tobacco Cessation

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Usual care group

**Description:** 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

**Name:** Usual Care

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** The Percentage of Self-reported Tobacco Cessation Attempts Between Groups

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact

**Time Frame:** 3 months

**Description:** 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

**Measure:** The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.

**Time Frame:** 3 months

**Description:** 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

**Measure:** The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.

**Time Frame:** 3 months

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

**Measure:** The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients who meet the following criteria will be eligible for the study:

* Enrolled in CPCRS at the time of counseling (12/11-02/12),
* Current tobacco user as noted in KP HealthConnect as of the date of the routine CPCRS evaluation and counseling. For study purposes, tobacco use includes any use of cigarettes, pipe, cigars, snuff, and chew.
* Continuous KPCO Denver/Boulder membership during study time period

Exclusion Criteria:

* Patients who meet any of the following criteria will not be enrolled in the study:
* \<18 years of age,
* Non-English speakers,
* Deceased at time of survey, and/or
* Unable to provide consent

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aurora

**Country:** United States

**Facility:** Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado

**State:** Colorado

**Zip:** 80011

#### Overall Officials

**Official 1:**

**Affiliation:** Kaiser Permanente

**Name:** Alicia Cymbala, PharmD, BCPS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** BST Counseling Group

**Deaths Num At Risk:** 64

**Description:** 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. AE's captured for patients who obtained lab data and had contact with clinical Pharmacist (120)

**ID:** EG000

**Other Num at Risk:** 64

**Serious Number At Risk:** 64

**Title:** BST Counseling Group

**Group ID:** EG001

**Title:** Usual Care Group

**Deaths Num At Risk:** 56

**Description:** 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. AE's captured for patients who obtained lab data and had contact with clinical Pharmacist (120)

**ID:** EG001

**Other Num at Risk:** 56

**Serious Number At Risk:** 56

**Title:** Usual Care Group

**Frequency Threshold:** 0

**Time Frame:** 3 month follow up

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 64

**Group ID:** BG001

**Value:** 56

**Group ID:** BG002

**Value:** 120

**Units:** Participants

### Group

**ID:** BG000

**Title:** BST Counseling Group

**Description:** 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

### Group

**ID:** BG001

**Title:** Usual Care Group

**Description:** 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

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.1

**Value:** 66.6

#### Measurement

**Group ID:** BG001

**Spread:** 9.4

**Value:** 64.6

#### Measurement

**Group ID:** BG002

**Spread:** 8.7

**Value:** 65.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 44

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 40

#### Measurement

**Group ID:** BG002

**Value:** 76

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 64

#### Measurement

**Group ID:** BG001

**Value:** 56

#### Measurement

**Group ID:** BG002

**Value:** 120

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** Alicia.A.Cymbala@kp.org
**Organization:** Kaiser Permanente
**Phone:** 303-972-5384
**Title:** Alicia Cymbala
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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
**Parameter Type:** NUMBER
**Population Description:** Reported not smoking at follow up survey
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** The Percentage of Self-reported Tobacco Cessation Attempts Between Groups
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** 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
**ID:** OG000
**Title:** BST Counseling Group
##### Group
**Description:** 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
**ID:** OG001
**Title:** Usual Care Group
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Three control patients reported participation in the Colorado quitline
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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
**ID:** OG000
**Title:** BST Counseling Group
##### Group
**Description:** 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
**ID:** OG001
**Title:** Usual Care Group
#### Outcome Measure 3
**Description:** 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
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 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
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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
**ID:** OG000
**Title:** BST Counseling Group
##### Group
**Description:** The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P \> 0.05)
**ID:** OG001
**Title:** Usual Care Group
#### Outcome Measure 4
**Description:** 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
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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
**ID:** OG000
**Title:** BST Counseling Group
##### Group
**Description:** The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P \> 0.05)
**ID:** OG001
**Title:** Usual Care Group
#### Outcome Measure 5
**Description:** The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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
**ID:** OG000
**Title:** BST Counseling Group
##### Group
**Description:** The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P = 0.013) Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up tele- phone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported ''Yes'' to baseline readiness to quit in the next 30 days. There were no statistically significant differences identified in the primary (P = 0.804) or secondary outcomes (all P \> 0.05)
**ID:** OG001
**Title:** Usual Care Group
### Participant Flow Module
#### Group
**Description:** 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
**ID:** FG000
**Title:** Usual Care Group
#### Group
**Description:** 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
**ID:** FG001
**Title:** BST Counseling Group
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 56
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 64
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 47
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 57
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
**Pre-Assignment Details:** 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.
**Recruitment Details:** 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.
**Has Results:** True