Clinical trial NCT02554071: Manitoba Pharmacist Initiated Smoking Cessation Pilot Project
Official title: Manitoba Pharmacist Initiated Smoking Cessation Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Govenment of Manitoba
name: Canadian Foundation for Pharmacy
name: Neighbourhood Pharmacy Association of Canada
First posted: 2015-09-18
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A single arm pilot study conducted to assess the feasibility of having Manitoba Pharmacists provide support (product and cognitive) to low-income (receiving social assistance) smokers wishing to quit smoking.

Detailed description: SYNOPSIS - Manitoba Pharmacist Initiated Smoking Cessation Program Overview Background The Manitoba government supports the role of the pharmacist as an integral part of the primary health care team delivering quality care and service to Manitobans. The role of the Pharmacist is ever evolving and expanding to meet the needs of their clients including comprehensive medication therapy management and expanded preventative expert. Community pharmacists are one of the most accessible health care professionals and provide a wide range of clinical services in the neighborhoods, towns, and cities across this province.

As part of the Manitoba government's wellness initiative, the government is strategically committed towards reducing the use of tobacco through public policy. Smoking is one of the leading causes of death in Manitoba and the use of tobacco is responsible for more than 50% of lung, respiratory, and oral cancers and a substantial factor in cardiovascular disease. While decreases in smoking rates have been achieved in recent years, Manitoba continues to exceed the national average of 17.3%, ranking the province with the third highest smoking prevalence. Manitoba' current smoking rates warrant continued efforts to reduce smoking in youth and adults.

While many believe smoking to be lifestyle choice it is also known to be a changeable lifestyle behavior and a significant determinant of health. It is also known to be a serious addiction that is very difficult to overcome both physically and emotionally. As part of Manitoba's targeted approach to smoking cessation, a partnership has been forged to develop and implement the pilot program: Manitoba Pharmacist Initiated Smoking Cessation Program.

Methodology The role of the pharmacist can best be described as underutilized and often an under recognized resource in smoking cessation programs. For individuals who smoke, many find smoking cessation overwhelming and difficult without assistance, including smoking cessation drugs and ongoing support and counselling. Many pharmacists have received additional knowledge and training specifically for initiating and monitoring a smoking cessation for individual clients. The Manitoba Pharmacist Smoking Cessation Program will provide access for 100 clients to the vital components necessary to quit smoking. Lower socioeconomic status is associated with higher rates of smoking. The Manitoba Employment and Income Assistance program provides support for lower income individuals in Manitoba. This smoking cessation program is a controlled pilot study providing clients with the most appropriate smoking cessation drugs along with the benefit of one to one pharmacist support and counselling.

Smoking Cessation Program Objectives

The following are the program objectives:

* Establish a provincial pilot smoking cessation program
* Reduce the number of Manitobans who smoke
* Enhance utilization of the pharmacist in preventative health care delivery

Program Scope A. Target Population

* 100 Manitoba residents over the age of 18 who are Manitoba Employment and Income Assistance active program participants as of January 01, 2014
* Provide written consent to participate in a smoking cessation program
* Agree to participate in the counselling sessions and smoking cessation behavior readiness
* Agree to participate in an evaluative process and follow up study

B. Participation Provider (Pharmacy and pharmacist)

1. Pharmacy/Pharmacists - Up to fifteen pharmacies throughout Manitoba who employ pharmacists professionally trained in QUIT and/or Catalyst, have previous experience providing smoking cessation services to patients, who are willing and able to commit to pilot project timelines, and who receive pharmacy manager approval will be eligible to apply to participate in this program.
2. In December 2013, MPhA will distribute application forms to each pharmacy for their voluntary consideration for participation and response to the call for applications. Each application form consists of a letter of introduction to explain the program and application process, a pharmacist manager application form, and pharmacist application form(s). The MPhA is the provincial regulatory body for pharmacists and pharmacies in Manitoba and thus has access to all pharmacy contact information. MPhA has agreed to utilize their mailing list and distribution system to communicate with all pharmacies in the province to ensure that equal access to any pharmacy and pharmacist in the province is achieved.
3. The Steering Committee will establish a Pharmacy Selection Sub-Committee to confidentially review all application forms for completeness and to select suitable complete a random selection process of all complete and eligible applications.
4. Up to 15 pharmacies in Manitoba who meet the provider eligibility criteria will be selected by the Pharmacy Selection Sub-Committee. All applicants will receive an outcome letter from the Program Manager following the selection process.
5. Successful pharmacy applicants will receive an orientation training program in the first week of January 2014 to share and educate pilot project details, participant recruitment processes, program implementation processes, methodology to complete participant informed consent and program surveys, evaluation requirements, and professional pharmacy reimbursement processes, and participant product reimbursement options.

Client Participation

1. Eligible participants in the pilot project include and Manitoba adult who meets the criteria of the targeted population cohort, and who have identified as being ready to quit smoking, will be eligible for the program.
2. Pharmacists participating as providers in the smoking cessation pilot project will be responsible for identifying eligible adults within their patient population as eligible for program participation.
3. All pharmacists in Manitoba are PHIA compliant.
4. Pharmacist providers will share with each potential participant a program information sheet, informed consent form, and access to a pharmacy staff person (pharmacy assistant/technician) not related to the pilot project and Pilot Project Project Manager contact information for access to pilot project information and independent decision making for project participation.
5. Completion of the Informed Consent Form will be independently completed by the potential applicant.
6. Support from an assigned pharmacy staff member not related to the pilot project will be made available should the potential applicant request.
7. Potential applicants will be encouraged to consult with their primary health care provider.
8. Each project participant:
9. Be introduced to the smoking cessation program and if interested given the informed consent to review. They may also be provided with some general educational materials on smoking cessation ii. Once the participant has had sufficient time to review the consent and has had all questions answered, the pharmacy assistant/technician will obtain informed consent.

iii. After consent has been obtained the patient will be provided with some forms to complete to assess their current smoking patterns and readiness to quit. When the completed forms are returned an initial assessment interview will be booked with the pharmacist.

iv. During the initial assessment interview:

1. The pharmacist will assess the level of dependence from the completed Fagerstrom Tolerance Scale and assess the motivations for smoking from the Why Test.
2. Potential drug interactions between medications and smoking/smoking cessation will be assessed.
3. The participant will be introduced to the Smoking Cessation Form and asked to record the symptoms, triggers, cessation product use and side effects on a daily basis.
4. The participant will be provided with a variety of educational materials to help guide their individualized quit plan (How Do I Want to Quit?, Why Do I Want to Quit?, When Do I Want To Quit?)
5. The pharmacist will work with the participant to complete the Pre-Quit Planning form
6. Additional Educational materials may be provided as needed ( Count Down to Quit Date, Breaking the Cycle of Addiction Date, My Reasons to Quit Smoking, Enlisting Support) v. Quit Day Visit:

1. The pharmacist will work with the participant to complete the Quit Day Plan. 2. The participant will be provided with the Quit Diary to record smoking 3. Additional Educational materials will be provided as needed (Managing Withdrawal Symptoms, Minimizing Weight Gain, Dealing with the Urge to Smoke, Managing Slips and Relapse, List of Resources).

4. Ensure the participant has a copy of the Smoking Cessation Assessment From for future telephone follow-ups.

vi. Phone Follow-up - 1 Week Post Quit

1. The pharmacist will provide telephone follow-up and review what has worked well and any challenges with withdrawal they have experienced. The Quit Plan will be modified as needed.
2. They will complete the Smoking Cessation Assessment Form with the patient. vii. 1 Month Post Quit Visit

1. The pharmacist will meet with the participant and review what has worked well and any challenges with withdrawal they have experienced. The Quit Plan will be modified as needed.

2. They will complete the Smoking Cessation Assessment Form with the patient. viii. 3 Month Quit Visit

1. The pharmacist will meet with the participant and review what has worked well and any challenges with withdrawal they have experienced. The Quit Plan will be modified as needed.
2. They will complete the Smoking Cessation Assessment Form with the patient.
3. Ensure the participant has a copy of the Smoking Cessation Assessment From for future telephone follow-ups.

ix. Phone Follow-up - 6 Month Post Quit

1. The pharmacist will provide telephone follow-up and review what has worked well and any challenges with withdrawal they have experienced. The Quit Plan will be modified as needed.
2. They will complete the Smoking Cessation Assessment Form with the patient.
3. Make a transition plan to ensure the participant has access to remaining to necessary support and suitable covered medications to maintain smoking cessation.

C. Program Duration Total duration of the study will be a 6-15 months. The participant will have access to smoking cessation pharmacy counseling services and smoking cessation products for a period of three months from the initiation in the pilot project. The intervention component of the pilot project will be available between January and April 2015.

Eligibility criteria: Inclusion Criteria:

* smoker
* \>= 18 years
* receiving Manitoba Employment and Income Assistance as of January 1st 2015
* Stated desire to quit smoking
* Signed Consent with associated agreement to participate in evaluation and follow-up

Exclusion Criteria:

* \< 18
* Not on Income Assistance
* Current non-smoker

Primary outcomes:
measure: Smoking Cessation Assessment
timeFrame: 6 months
Secondary outcomes:
measure: Smoking Cessation Assessment
timeFrame: 1 month
measure: Smoking Cessation Assessment
timeFrame: 3 months
measure: Smoking Cessation Product
timeFrame: 3 months
measure: Quit Diary
timeFrame: 6 months
Other outcomes:
measure: Cigarettes Smoked
timeFrame: day 0, 1 month, 3 months and 6 months
measure: Pharmacist Time
timeFrame: 6 months
Locations:
city: Winnipeg
country: Canada
facility: College of Pharmacy, University of Manitoba
state: Manitoba
Study officials:
affiliation: College of Pharmacy, University of Manitoba
name: Shawn C Bugden, PharmD
role: PRINCIPAL_INVESTIGATOR
References: