Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption (ODHIN_RCT)

Fundacion Clinic per a la Recerca Biomédica

Status: Completed

Conditions: Alcoholism

Treatments: Other: Financial incentive; Other: E-SBI (online screening and brief intervention); Other: Training and support (T&S)

Study type: Interventional

Funder types: Other

Identifiers

NCT01501552

ECGA259268

Details and patient eligibility

About

The overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.

Full description

The study will be a stepped cluster RCT in 5 countries and the endpoint of the study is the number of interventions delivered during a certain time period. More specifically, the RCT will examine:

• The effect of Continuous Medical Education (CME) to PHC providers
• The effect of financial reimbursement to PHC providers as a pay-for-performance of brief alcohol interventions
• Whether an alternative internet based method of delivering brief intervention can increase the proportion of patients reached
• If one implementation strategy will give an added value to one already enforced.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Health Care Units (PHCU) of approximate size of 5.000-20.000 registered patients
• Primary Health Care Units (PHCU) located in Spain, Poland, Sweden, England or The Netherlands
• Providers must be physicians or nurses

Exclusion criteria

• Primary Health Care Units with less than 5.000 registered patients or over 20.000 registered patients

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 8 patient groups

Treatment as usual

No Intervention group

Description:

In the no-intervention treatment as usual group, a package, containing a summary card of the national guideline recommendation, will be delivered to each provider unit without demonstration. In Poland, the summary card will be adapted from the PHEPA guidelines (ref) for the purposes of this trial. The treatment as usual group will be requested to screen and offer person-to-person SBI at the PHCU.

Training & support (T&S)

Experimental group

Description:

The T\&S only group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) may be offered. The time interval between meetings will be on average 2 weeks. The training sessions will address improving knowledge, skills, attitudes, and perceived barriers and facilitators by combining theory and practice-based training.

Treatment:

Other: Training and support (T&S)

Financial incentive

Experimental group

Description:

The financial incentive only group will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.

Treatment:

Other: Financial incentive

E-SBI

Experimental group

Description:

The e-SBI (online screening and brief intervention)only group are expected to refer identified at-risk patients to an approved e-SBI programme, which will be either country specific (where these exist) or based on the WHO e-SBI programme (Poland).

Treatment:

Other: E-SBI (online screening and brief intervention)

T&S and financial incentive

Experimental group

Description:

The T\&S and financial incentive group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. Also, they will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.

Treatment:

Other: Financial incentive

Other: Training and support (T&S)

T&S and e-SBI

Experimental group

Description:

The T\&S and e-SBI group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call was offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) was offered. Also this group is expected to refer identified at-risk patients to an approved e-SBI (online screening and brief intervention) programme, which will either be country specific (where these exist) or based on the WHO e-SBI programme (Poland).

Treatment:

Other: E-SBI (online screening and brief intervention)

Other: Training and support (T&S)

Financial incentive and e-SBI

Experimental group

Description:

The financial incentive and e-SBI (online screening and brief intervention) group will be paid for screening and referral performance instead of actual delivery of e-SBI by themselves as in line with the e-SBI only group, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.

Treatment:

Other: Financial incentive

Other: E-SBI (online screening and brief intervention)

T&S, financial incentive and e-SBI

Experimental group

Description:

The T\&S, financial incentive and e-SBI (online screening and brief intervention) group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Also, they are expected to offer screening at the PHCU and to refer screen positive patients to e-SBI programmes. Additionally, they will be paid for screening and referral performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.

Treatment:

Other: Financial incentive

Other: E-SBI (online screening and brief intervention)

Other: Training and support (T&S)