Table 1 Methodology of the work packages (WPs) 1–6 of the OptiCor project

Phase I: Quantitative and qualitative needs analysis including the systematic development of the intervention (training), and preparatory work for future health economic analyses (study years 1–2)

WP1:

Cross-sectional population survey

24 months

Primary research question:

• What is the proportion of people with IHD who report having received GP-delivered advice on PA according to the 3As method: ask/assess, advise, assist?

Secondary research questions:

• From the perspective of people with IHD, is there a wish for GP-delivered advice on PA, and if so, what specifically is the desired content of advice?

• Are these outcomes associated with specific person characteristics (e.g., age, sex, education, body mass index, current PA level)?

• Nationwide, cross-sectional, computer-assisted, face-to-face household survey in approximately 1000 respondents aged ≥ 35 years with self-reported IHD and at least one GP visit since last remembered IHD-event

WP2:

Qualitative study on GPs’ and patients’ attitudes, experiences, and needs

20 months

Research aims

• What are the experiences of GPs and people with IHD with providing/receiving advice on PA?

• Which attitudes, motivators, barriers and supporting factors for the routine implementation of PA advice by GPs can be identified?

• What kind of needs do GPs haves with regard to a GP training on advising on PA?

• Individual problem-centred interviews with GPs (n = 8–12) and people with self-reported IHD (n = 8–12)

• 4–6 focus group discussions with GPs (n = max. 10–12 per group) and people with IHD (n = max. 10–12 per group)

 WP3:

Development of the GP training

8 months

Aims:

Development of a theory-based, brief, single-session, tailored GP training to deliver PA advice according the very brief 3As method during routine consultations with people with IHD

• The development will make use of the COM-B behaviour change theory [36], and will aim to describe the active elements of the intervention by using the behaviour change taxonomy [29]

• The development will consider results from WP1 and WP2

WP4:

Health economic preparatory work

18 months

Aims (further aims of WP4 are listed under WP6):

• Development of a DCE

• Development of a questionnaire regarding health care utilisation in IHD patients

DCE:

• Literature review

• Qualitative semi-structured individual interviews with people with IHD based on an interview guide (n = 8–12)

• Expert workshop (e.g., people with IHD, GPs, cardiologists)

Health care utilisation questionnaire:

• Literature review and consideration of previous work by members of the study team [51]

Phase II: Piloting of the intervention and of the main evaluation study (study years 2–3)

WP 5:

Pilot study

18 months

• What are the pilot implementation outcomes including the training of GP peer trainers, recruitment and randomisation processes, content and schedule of the training, materials, and methods of data collection among patients and GPs including pre-tests of study questionnaires?

Process evaluation:

• To what extent can the GP training content be transferred into practice?

• What factors facilitate or hinder the transfer?

• How do the GPs experience the implementation of brief PA advice?

• Whatarethe patients' experiences with the GP advice they received (if so) and their met and unmet needs?

Health economic accompaniment:

• Is it feasible to elicit preferences on increased PA in IHD patients using the DCE?

• Pilot study as a “scale model” of one study cycle of the main pragmatic cRCT; One study cycle: 10 GP practices (intervention group n = 5, control group n = 5; pilot sample of 12 patients with IHD per practice = 120 patients)

Process evaluation:

• Process evaluation with semi-structured, problem-centred individual interviews with GPs (n = 6–8) and their patients with IHD (n = 6–8)

Health economic accompaniment:

• Pilot testing of the DCE (see WP4, n = 120 patients with IHD)

Phase III: Main evaluation study by means of a pragmatic, two-arm cluster randomised controlled trial (cRCT), including process evaluation and health economic accompaniment (study years 4–5)

WP 6: Main evaluation study

24 months

Primary research question:

• What is the proportion of people with IHD who report receiving brief advice on PA during a routine consultation with their GPs of the intervention group compared to GPs of the control group?

Secondary research questions:

• What is the proportion of people with IHD whose current PA level was assessed by the GP?

• What is the proportion of people with IHD who received specific recommendations or information about duration, frequency, or type of PA exercise and/or patient information sheets with information about PA?

• What is the proportion of people with IHD who received an offer for a follow-up appointment with the GP to monitor or discuss PA level?

• How satisfied are the people with the advice they received (if so)?

Further research questions:

• What is the short-term training effect on GPs' reported attitude, opportunity, knowledge, and practical skills in providing advice on PA?

Process evaluation:

• What are facilitators and barriers of GPs to the routine implementation of PA advice, including reimbursement strategies for its routine provision? 

• What are the patients' experiences with the GP advice they received (if so; including facilitators and barriers for the implementation of the advice by their GPs)?

Accompanying health economic research:

• Which preferences do people with IHD have regarding outcomes on increased PA?

• Is it adequate to assess health care utilisation in IHD patients with the developed questionnaire?

• Full pragmatic, two-arm cRCT with randomisation (1:1); data collection in 50 GP practices (25 per study arm) and in a study sample of n = 300 people with IHD per study arm

Process evaluation:

• Semi-structured qualitative interviews with people with IHD who received PA advice from a GP of the intervention group (n = 30–40)

• Qualitative process evaluation with GPs (n = 8–12)

Health economic accompaniment:

• Evaluation of the DCE in people with IHD of the control group of the cRCT (see WP4, n = 300)

• Piloting of the health care utilisation questionnaire in patients of the control group of the cRCT (n = 300)