Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02554071 |
| Other study ID # |
H2013:459 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
September 16, 2015 |
| Last updated |
September 16, 2015 |
| Start date |
January 2014 |
| Est. completion date |
November 2014 |
Study information
| Verified date |
September 2015 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Ethics Review Committee |
| Study type |
Interventional
|
Clinical Trial 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.
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.
