The aims of the pilot phase of the study were:
1. to assess the feasibility of the procedure in terms of:
i. searching medical records and mailing screening questionnaires ii. the randomisation and generation of the tailored letters iii. delivery of the intervention.
2. to ascertain recruitment rates
3. to assess the uptake of the taster sessions and subsequent attendance at the SSSs. The criteria for judging the success of the pilot phase and proceeding to full trial is based on:
1. achieving a 7% response rate (i.e. a mean of 42 participants per practice giving consent and agreeing to randomisation) in the first 12 practices
2. a preliminary analysis that suggests that the difference in uptake of SSSs between the intervention and control groups is greater than zero.
Successful achievement of recruitment, the rate of uptake in attendance at the taster session, and the uptake of SSSs in the intervention group will allow progression to the main trial in a further eight areas that are representative of the SSS.
Planned recruitment
We planned to recruit practices and participants through the PCRN, in two areas selected for the pilot phase. Practices generally identify 13% to 22% of their patients as smokers,55depending on the
characteristics of the patient population, and the accuracy and completeness of the records. Based on the response rate from previous and ongoing studies29,56we estimated a response rate of 7% from smokers
motivated to quit, from two mailings. By selecting six practices in each of the two SSSs with a list size of >4000, we aimed to secure 504 participants to the pilot phase of the randomised controlled trial. Progress
The pilot phase for Start2quit was carried out between September 2010 and December 2011.
Research and development approval
The two original SSSs selected for the pilot phase of Start2quit were Camden and Berkshire East. Although provisional approval was gained from Berkshire East Primary Care Trust (PCT), the SSS manager made a late decision to withdraw from the trial. With the help of the CLRN lead in the Thames Valley (Dot Powers), we were able to recruit Oxfordshire SSS as the second area for the pilot phase. Research and development approval was granted by our lead NHS site, Camden PCT, on 16 December 2010, followed by site-specific approval for Oxfordshire PCT on 21 January 2011.
1. Assessing the feasibility of the procedure in terms of:
Searching medical records and mailing screening questionnaires During the pilot phase, procedures for searching medical records and mailing screening questionnaires for the recruitment of participants were implemented. A search strategy for identifying current smokers aged over 16 years on computerised records at GP practices was created and used by practice staff. Although there were small differences in the codes that practices use to record patients’smoking status, our search strategy was effective in identifying potential participants for this project. Using computer programs written specifically for Start2quit, invite letters were generated in practices and sent with screening questionnaires to smokers identified in the initial search. One such program was designed to successfully remove duplicate addresses, ensuring that only one smoker per address was invited to the study. Sending invite letters and questionnaires with pre-addressed Freepost envelopes ensured that responses were returned to the practices without charge to the participants. The mailing of the invites was performed by trained practice staff aided by members of the research team and instruction manuals (Practice Manual and Research Manual).
The randomisation and generation of the tailored letters The subsequent randomisation of fully consenting, eligible participants was performed independently by a computer program designed during the pilot phase. This program also generated the intervention and control letters. Data from questionnaires and medical records of consented participants were collated and entered on to an Excel spreadsheet. Using this spreadsheet, the computer program was able to randomly assign each participant to the control or intervention group and then generate the personal tailored risk letters and taster session invitation cards for participants in the intervention group, and control letters for participants in the control group. This program was run effectively by trained research staff visiting the practices. Some minor amendments to the intervention and control letters were required because of differences in the organisation of SSSs, but these changes did not hamper the progress of the pilot phase. As a result of lessons learnt during the pilot phase of Start2quit, minor amendments have been made to all computer programs used in the study. Many of these changes have made the programs more‘user-friendly’and have reduced process time.
Delivery of the intervention Procedures for the delivery of taster sessions to participants in the intervention group were also created during the pilot phase of Start2quit. In collaboration with advisors from the SSSs, a protocol for running taster sessions and an Advisor Training Manual were prepared to ensure standardisation of the delivery of the sessions. Advisors, trained by the research team to run taster sessions, ran these sessions between March and July 2011 in Camden and Oxfordshire SSSs. In total, four taster sessions were run by Camden SSS and 10 sessions were run by Oxfordshire SSS (five sessions in
Oxford and five sessions in Banbury). In each area, participants were invited to one of three initial taster sessions. If they failed to attend, they were then invited to another taster session held 3 months later. Depending on participant numbers in each area, either one or two more sessions at this 3-month time point were required. Throughout the pilot phase, a number of documents required for the effective running of taster sessions were found to be required. These included an audio-recording consent form, evaluation form and an advisor details form.
2. Ascertain recruitment rates
The rate of participant recruitment to the trial throughout the pilot phase was determined and is presented in theResultssection of this report.
3. Assessment of the uptake of the taster sessions and subsequent attendance at the Stop Smoking Services
The number of participants who were randomised to the intervention arm and, subsequently, attended a taster session was recorded throughout the pilot phase and is presented in theResultssection of
this report.
The primary outcome of attendance at the SSSs for Start2quit is ascertained from records at the SSS. SSS records are updated quarterly and, therefore, not all participant data are available at present. Data from Oxfordshire SSS will be available in March 2012. Therefore, we will use participant self-reported
attendance as a proxy measure for the primary outcome for the pilot analysis described in this report. Self-reported attendance was collected by research telephone interviewers, independent from the service providers and research team, via follow-up interviews with participants 6 months after the date of randomisation. A computer program, which guides the telephone interviewers through this process was developed and used during the pilot phase. A Telephone Interviewer Manual was designed to ensure standardisation of the delivery of the interviews. These follow-up interviews were conducted between September 2011 and December 2011 for all participants in Camden and Oxfordshire.
Participant self-reported attendance at the SSSs was obtained from the 6-month follow-up interviews, which contained the following questions relevant to this outcome measure:
1. Have you tried to make an appointment with the SSS (this includes making an appointment with a practice nurse or health-care assistant at your surgery for stop smoking advice)?
2. Were you successful in making an appointment with the SSS?
3. How many times in the last 6 months have you attended any appointments with the SSS (this includes making an appointment with a practice nurse or health-care assistant at your surgery for stop
smoking advice)?
If the participants answered‘yes’to the first two questions, and reported at least one appointment in responding to question 3, then they were classified as having attended with the SSS. All others were classified as not having attended. Analysis followed the intention-to-treat principle. Those lost to follow-up were assumed to have not attended the SSS.
Descriptive analysis was carried out. For each treatment group the proportion of participants who attended out of all participants in that group was calculated. These proportions are presented for all participants and for each SSS separately.