Procedures

4.11.1 "Trained Nurse" model

4.11.1.1 Recruitment of individual participants

Initial contact with participants was opportunistic, with the aim being to approach every patient attending the practice during a spirometry session and request their participation if they belonged the “target group”, being over 35 years of age and a

regular smoker of tobacco, currently or in the past. The practice receptionists offered an information sheet (Appendix 9: Patient information and consent) with the initial questionnaire (Appendix 10: Questionnaire A) as patients arrived. The visiting trained nurse also asked practice patients sitting in the waiting areas to participate during any breaks in testing. Individual practice patients who did not wish to have a spirometry test were requested to complete Questionnaire A as far as possible and no further contact with these participants was made.

Trained nurses were also available to perform spirometry if requested by the GP on any patient. Unless the patient was in the target group, no additional study

procedures were carried out.

Practice patients who attended on other days were also recruited through posters informing patients about the study, recommendation of the GP or another health professional. If they completed the initial questionnaire and provided their contact details, the trained nurse would make telephone contact and offer an appointment for a suitable time to attend for full enrolment.

4.11.1.2 Consent

Each spirometry test on a participant in the target group commenced with a verbal explanation of the study given by the trained nurse and review of the written information sheet (Appendix 9). If the patient consented to participate and undergo spirometry they were asked to sign the attached consent form. A signed copy of the consent form and the information sheet was given to each participant. A signed consent form was retained for each participant.

4.11.1.3 Questionnaire A

Each participant recruited in the target group completed this in the waiting room. They were checked for completeness by the trained nurse prior to testing for those who agreed to spirometry [Appendix 10].

4.11.1.4 Spirometry

In order to exclude any participant for whom there might be a risk of an adverse effect from performing spirometry, the trained nurse asked three safety questions and excluded any with a positive response. These potential participants were invited to enrol after the required waiting period had elapsed.

1. Have you had major surgery in the past six weeks- eye, abdominal, chest, brain or other?

2. Have you had been in hospital with a (heart attack) myocardial infarction or severe angina in the past six weeks?

3. Do you have abdominal pain, nausea or diarrhoea?

A measurement of the participant’s height was obtained using a measuring device previously checked for accuracy. Patient details were entered into the spirometer. The breathing manoeuvres required to perform a test were described in detail and demonstrated, emphasising complete exhalation (Figures 4.2, 4.3, 4.4).

Testing was continued until three acceptable tests had been performed or until the patient declined to continue. The number of attempts was recorded. Upon

satisfactory completion of the test, the nurse viewed the results and compared them to the study algorithm. The time taken to complete the test was recorded from the time after consent to participate was obtained until after communication of the result to the participant. This included asking safety questions, measuring height and weight, performing expiratory manoeuvres, classification of the result against the algorithm and feedback to the participant.

Figure 4.2: The trained nurse demonstrates the EasyOne spirometer while describing the breathing manoeuvres to be used

Figure 4.3: The trained nurse demonstrates full inspiration while coaching a subject during spirometry.

Figure 4.4: The trained nurse demonstrates full expiration while coaching a subject during spirometry.

4.11.1.5 Feedback of spirometry result to participant

The result of classification was communicated to the participant immediately after testing. The trained nurse presented and gave feedback on results to participants. Participants with normal lung function (NLF) were informed that there was no evidence of damage to the airways at the moment and GP follow up was not suggested unless the participant required further explanation or sought advice on smoking cessation.

Participants with obstructive lung function (OLF) were informed that there was evidence of some changes or damage in the airways, most likely related to smoking. They were requested to make an appointment with the GP to follow up the results. Participants classified with restrictive lung function (RLF) were informed there was evidence of some change in lung function but this was probably unrelated to

smoking. Follow up by the GP was advised for the participant to receive further explanation and investigations or advice on smoking cessation. A restrictive

ventilatory defect suggested by spirometry results, requires formal measurements of lung volumes for confirmation and quantifying (46).

4. 11.1.6 Report to GP

All spirometry results were printed via a printer linked to a PC in the research office. They were faxed to the participant’s practice within 48 hours of testing. Printed results were de-identified apart from the study identification number and retained for assessment of quality and comparison of classification by a respiratory physiologist.

4.11.1.7 Brief smoking cessation advice to current smokers

It was decided that ethically in the best interests of participants, all current smokers should be counselled on the importance of smoking cessation. A systematic review of studies using minimal intervention by a physician, defined as a brief stop smoking message with or without printed materials, found it was effective in increasing the rate of smoking cessation, odds ratio 1.74 (95% CI 1.48 to 2.05) (143).

After being notified of the spirometry result, the same brief clear message was given to any participant who was a smoker.

“It is important for you to quit smoking now and you can find help in the Quit booklet”.

A booklet published for Quit Tasmania covering the topics: deciding to quit, getting ready to quit, quitting, staying a non-smoker and coping with setbacks and including a telephone number for seeking assistance, was given to all current smokers.

4.11.1.8 Follow up spirometry result: smokers 4.11.1.8.1 Questionnaire B

Participants who were current smokers completed Questionnaire B (to collect additional demographic data and retest attitudes to health and smoking and stage of change) immediately after receiving feedback on their spirometry result. If time did not permit immediate completion, it was returned by mail in a postage-paid envelope [Appendix 11].

4.11.1.8.2 Questionnaire C

Questionnaire C was sent to participants who were current smokers three months following spirometry for self-completion, with a postage-paid envelope supplied for its return [Appendix 12]. If it was not returned within two weeks, attempts to make contact by telephone were made and if successful the questionnaire administered by telephone. If phone contact was unsuccessful, a repeat questionnaire was sent to the address supplied at recruitment. A minimum of three attempts was made to contact each participant before classifying them as lost to follow up.

4.11.1.9 Focus group follow up of spirometry model

A focus group lasting 90 minutes was scheduled with each participating practice after completion of the first six months. All doctors, practice nurses and practice managers were invited to attend. Groups met at the practices premises, normally outside consultation times. The facilitator greeted participants, while refreshments were served as they gathered. The facilitator commenced with an overview of the study, an explanation of the conditions that applied to the discussion: confidentiality, anonymity, and the right to withdraw or not to answer a question. All participants were asked to sign and consent form and permission was sought to turn on a tape recorder. A recording was made using a multi-directional microphone situated centrally on a table. A note-taker recorded the order of speakers and initial words. The following question were used to guide discussion in the group:

2. Have there been any drawbacks from having spirometry conducted by the nurse in your practice?

3. How have you used the spirometry results?

4. Were there any barriers? Were you able to make the best use of the spirometry results?

5. Are there any comments regarding spirometry, the study or alternative ways of using spirometry in general practice?

In order to stimulate discussion about use of spirometry in the diagnosis of COPD, scenarios were used in which two examples of spirometry results and flow-volume curves were provided to each participant. Some clinical information on the subject was provided, smoking history, MRC breathlessness grade, self- rating of own health, strength of belief that smoking has caused lung damage and strength of belief in the benefits of quitting smoking.

Discussion around the scenario was facilitated with the following questions: 6. Would you feel confident making a diagnosis from this spirometry result? 7. How would this result add to your ability to make a diagnosis?

8. What would you say to this patient about these results? [Appendix 13: Spirometry examples]

4.11.1.10 Follow up spirometry result: records extraction

Participants with spirometry results in the following categories were selected for review of their practice records by the following criteria:

1. Classified by the algorithm as OLF or RLF

2. Classified by the algorithm as NLF and a current smoker.

Records were reviewed after a minimum period of three months post-spirometry to allow a reasonable opportunity to organise follow up with the GP and completion of any further investigations.

4.11.2 "Usual Care" model

4.11.2.1 Recruitment of individual participants

In the practices allocated to the "usual care" model, posters promoting spirometry in patient waiting areas or computer prompts to doctors for spirometry screening in the target group could be used, but doctors used their clinical discretion to carry out testing. The purpose of the posters was to increase general awareness but not to request volunteers. Participants were recruited when a GP performed spirometry on a

patient in the target group, or referred such a patient to the practice nurse for spirometry.

Any practice patient in the target group who had lung function measured was given an information sheet and a one-page questionnaire, based on that used in TN practices (omitting questions on the reasons for agreeing to or refusing spirometry, and self-rating of general health, lung damage and benefits to quitting smoking) [Appendix 14: Questionnaire A-UC].

Booklets published for Quit Tasmania on smoking cessation were supplied to each practice to be given to all current smokers.

Results of spirometry tests performed were downloaded for analysis at monthly intervals by researchers and a payment of $10 was made for each test on a patient in the target by whom a Questionnaire A-UC was completed. GPs also used the

spirometer for clinical indications or medical examinations for patients of any age. The number of tests performed was assessed. Researchers assessed the quality of downloaded tests and classified results according to the study algorithm.

4.11.2.2 Consent

Each participant in the target group who had spirometry test in the practice was supplied with written information sheet. If the patient consented to involvement in the study they were asked to sign the consent form attached [Appendix 15]. A signed copy of the consent form and the information sheet was given to each participant. A signed consent form was retained for each participant.

4.11.2.3 Questionnaire A

This was completed after spirometry by each participant recruited in the target group [Appendix 14]. They were returned to practice staff and collected by researchers monthly or returned direct to the research office by mail (reply-paid envelope supplied).

4.11.2.4 Spirometry

An EasyOne spirometer was supplied to each practice with a supply of spirettes. Practice nurses and doctors who performed testing had received training in spirometry and use of the EasyOne spirometer. They recorded the participant’s height and patient details in the spirometer. They were requested to continue testing

until three acceptable tests had been performed or until the patient declined to continue.

4.11.2.5 Assessment of spirometry quality

All spirometry tests were printed via a printer linked to a PC in the research office. Printed results were de-identified apart from the study identification number and retained for assessment of quality and comparison of classification by a respiratory physiologist.

4.11.2.6 Follow up spirometry result: records extraction

Participants who had given consent whose spirometry results were classified in the following categories, were selected for review of their practice records:

1. Classified by the algorithm as OLF or RLF

2. Classified by the algorithm as NLF and a current smoker.

Records were reviewed after a minimum period of three months post-spirometry to allow a reasonable opportunity to organize follow up with the GP and any further investigations to be completed.

4.11.2.7 Focus group follow up of spirometry model

A focus group lasting 90 minutes was scheduled with each participating practice after completion of the first six months. All GPs, practice nurses and practice managers were invited to attend. Groups met at the practices premises, normally outside consultation times. The facilitator greeted participants and refreshments were served while they gathered. The facilitator commenced with an overview of the study, an explanation of the conditions that applied to the discussion: confidentiality, anonymity, and the right to withdraw or not to answer a question. All participants were asked to sign and consent form and permission was sought to turn on a tape recorder. A recording was made using a multi-directional microphone situated centrally on a table. A note-taker recorded the order of speakers and initial words.

The following question were used to guide discussion in the group: 1. How have you used the spirometer?

2. Have there been any benefits from having the easy to use spirometer in your practice?

4. Were there any barriers? Were you able to make the best use of the spirometer?

5. Are there any comments regarding spirometry, the study or alternative ways of using spirometry in general practice?

In order to stimulate discussion about use of spirometry in the diagnosis of COPD, scenarios were used in which two examples of spirometry results and flow-volume curves were provided to each participant. Some clinical information on the subject was provided: smoking history, MRC breathlessness grade, self- rating of own health, strength of belief that smoking has caused lung damage and strength of belief in the benefits of quitting smoking. Discussion around the scenario was facilitated with the following questions:

6. Would you feel confident making a diagnosis from this spirometry result? 7. How would this result add to your ability to make a diagnosis?

8. What would you say to this patient about these results? [Appendix 13: Spirometry examples]

4.11.3 Feedback on spirometry to practices

At the conclusion of twelve months in January 2006 all practices received a letter of thanks for their participation, and a report on their spirometry utilisation and quality of the tests performed by the practice.