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Table 4 Process outcomes

From: Efficacy of motivating short interventions for smokers in primary care (COSMOS trial): study protocol for a cluster-RCT

Process evaluation outcome

Source

Reach: proportion and representativeness of individuals receiving the intervention (individual level)

 Rate of smokers among the GP's patients

GP

 Rate of smokers invited to participate

GP

 Rate of refusals, with reasons

GP

 Patient dropout rate, with reasons

GP

 Patients’ characteristics and representativeness

See covariates

Efficacy: success rates of the intervention (including satisfaction outcomes) under study conditions (individual level)

 Behaviour change rates

See outcomes

 Changes in self-efficacy and planning

See outcomes

 Patients’ current overall satisfaction with coaching programme

Patient

Adoption: proportion and representativeness of organisations willing to adopt the intervention, with consideration of enablers and barriers to adoption (organisational level)

 Rate of GPs invited to participate

SC

 Rate of refusals, with reasons

SC

 GP dropout rate, with reasons

SC

 GPs' characteristics and representativeness

See covariates

 Involvement of medical assistants/nurses

See covariates

 Assistants'/nurses' characteristics

See covariates

 Assessment of GPs' precognitions, understanding of coaching/counselling concept and increase in knowledge and skills, evaluation/rating of coaching/counselling concept and structure of training, recommendation to colleagues

GP

 Time required for coaching/counselling

See covariates

 Rating of coaching/counselling tools in matters of usefulness and manageability, enabling factors and barriers in coaching/counselling as perceived from practical experience

GP

 Overall assessment: benefit for daily practical work, most crucial aspects (success factors and pitfalls), suggestions for improvement, overall satisfaction

GP

Implementation: extent to which the intervention is implemented under real-world conditions—patient adherence (individual level) and adherence of staff to study protocol (organisational level)

 Number of coaching/counselling sessions per patient

See covariates

 GPs'/assistants'/nurses' attitudes, competences and (mental) barriers towards/in/to delivering the interventions

GP

 Changes in contents or duration of coaching/counselling elements during the ongoing trial

GP

 Completeness/integrity of data reported by GPs

SC

 Costs arising from expenditure of coaching time

SC

Maintenance: sustainability of intervention over time—relapse rates (individual level) and integration of intervention into institutional routine (organisational level)

 Upholding of beneficial behaviour at 12 months after end of follow up

Patient

 Number of GPs trained in HC until 12 months after end of follow up

HC registry

 Number/frequency and quality/intensity of coaching over a period of 12 months beyond follow up

GP

 Response among experts and media coverage

Experts, media

 Maintenance costs

GP

  1. GP general practitioner, HC Health Coaching programme, SC study centre