Trial document




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  DRKS00015882

Trial Description

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Title

Feasibility of alcohol screening and brief intervention in primary health care in Kazakhstan: a pilot cluster randomized trial

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Trial Acronym

ASBIKaz

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URL of the Trial

[---]*

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Brief Summary in Lay Language

(1) Background:
Alcohol screening and brief intervention delivered in primary health care is a prime example of a clinical cost-effective preventive approach that has the potential to achieve a substantial and positive public health impact if effectively implemented in primary health care settings. Whilst the majority of alcohol screening and brief intervention research has been conducted in western, high-income countries, the evidence is growing that alcohol screening and brief intervention can also impact positively on heavy drinkers in low and middle-income country populations. This mixed methods feasibility trial includes a pilot cluster randomized trial and focus groups to explore for the first time the feasibility and acceptability of alcohol screening and brief intervention and its implementation processes in primary care in Kazakhstan. The study outcome will be relevant for the future development, tailoring and implementation of alcohol screening and brief intervention in Kazakhstan.

(2) Methods and analysis:
Six primary health care units in the region of Pavlodar, Kazakhstan, will be cluster randomized in an interventional (WHO manualised 5 minutes alcohol brief intervention plus alcohol leaflet) and control group (treatment as usual plus alcohol leaflet). The specific objectives of this pilot cluster randomized trial are to explore whether a full randomized controlled trial is warranted and feasible by estimating relevant parameters such as rates of eligibility, participation and retention at three months follow-up and to explore the acceptability of the ASBI from patients` and physicians` perspectives. Besides acceptability, two focus groups with 5-8 physicians will be used to explore further outcome measures such as reach, effectiveness, adoption, implementation and maintenance, as well as views on study procedures and ethical aspects.

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Brief Summary in Scientific Language

(1) Background and Objectives:
Identifying and addressing heavy drinking represents a major public health priority worldwide. Whilst the majority of alcohol screening and brief intervention (ASBI) research has been conducted in western, high-income countries, the evidence is growing that ASBI can also impact positively on heavy drinkers in low and middle-income country populations. This mixed methods feasibility trial includes a pilot cluster randomized trial and focus groups to explore for the first time the feasibility and acceptability of ASBI and its implementation processes in primary care in Kazakhstan. The study outcome will be relevant for the future development, tailoring and implementation of ASBI in Kazakhstan.

(2) Methods and analysis:
Six primary health care units in the region of Pavlodar, Kazakhstan, will be cluster randomized in an interventional (WHO manualised 5 minutes alcohol brief intervention plus alcohol leaflet) and control group (treatment as usual plus alcohol leaflet). The specific objectives of this pilot cluster randomized trial are to explore whether a full randomized controlled trial is warranted and feasible by estimating relevant parameters such as rates of eligibility, participation and retention at three months follow-up and to explore the acceptability of the ASBI from patients` and physicians` perspectives. Besides acceptability, two focus groups with 5-8 physicians will be used to explore further outcome measures on the basis of the RE-AIM framework (Reach, effectiveness, adoption, implementation and maintenance) (Glasgow et al. 1999), views on study procedures (e.g. screening process, timings) as well as ethical aspects.

The following parameters were changed with Amendment No. 1 of 1.4.2019:
Title, Brief Summary (Study Objectives), Interventions/Observational Groups, Primary Outcome, Secondary Outcome, Recruitment (Date of First Enrollment)

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Due to the pilot character of the study, data access will be limited to the involved research institutions.

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Organizational Data

  •   DRKS00015882
  •   2018/12/17
  •   [---]*
  •   yes
  •   Approved
  •   Application No. 641. Session of the Local Ethical Commission No. 8(72), Local Ethical Commission of Kazakh National Medical University named after S.D. Asfendiyarov 88 Tole Bi St. 050000 Almaty, Kazakhstan http:\\www.kaznmu.kz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   risky drinking
  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
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Interventions/Observational Groups

  •   In the interventional arm, female patients screened with an AUDIT-C score of 3 or lower and male patients screened with an AUDIT-C score of 4 or lower will receive a short feedback according to the level of alcohol use as well as a patient information leaflet on low-risk alcohol use. Female patients with an AUDIT-C score of 4 or higher and male patients with an AUDIT-C score of 5 or higher will receive a face-to-face alcohol brief advice delivered by trained PHC physicians plus a patient information leaflet with recommendations on low-risk alcohol use.
    The four-hour training is adapted on the basis of the WHO Alcohol screening and brief intervention training package. The intervention is based on the FRAMES concept, informed by motivational interviewing principles and will not take more than 5 minutes. The brief advice will include an extended personalized feedback in order to increase the patient’s awareness about his/her drinking habits and the related consequences and to increase the self-efficacy to change the drinking levels.
  •   In the control-arm all screened patients will receive a short feedback and a patient information leaflet on low-risk alcohol use.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Feasibilty and acceptance of ASBI in routine primary health care in Kazakhstan measured on the basis of
(1) rates of eligibility, participation and retention at three months follow-up and
(2) quantitative and qualitative data on the patient and provider perspective

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Secondary Outcome

(1) Reach:
(1a) Proportion of consulting adult patients intervened at baseline;
Numerator: Total number of patients screened and advised;
Denominator: Total number of patients screened positive
(1b) Proportion of patients screened at baseline;
Numerator: Total number of completed screens;
Denominator: Total number of all patients eligible for screening
(2) Effectiveness:
Change in AUDIT-C score between baseline and follow-up among patients with risky, hazardous or harmful drinking
(3) Adoption.
(3a) Proportion of staff invited that participated;
Numerator: Total number of participating physicians;
Denominator: Total number of primary care physicians invited
(3b) Description and representativeness of staff who delivered the screening and advice (PHC provider level)
(4) Implementation:
(4a) Quality and consistency of the delivery of ASBI given (PHC provider level; patient level) measured by quantitative interviews and open questions
(4b) Implementation determinants (barriers, facilitators) of ASBI delivery (PHC provider, Patient level) collected by quantitative interviews and open questions questions as well as focus groups
(4c) Cost of intervention (defined by time): Average time for screening and brief intervention per patient
(5) Maintenance:
Potential extent to which the intervention package becomes institutionalized (PHC provider level; patient level) collected by quantitative interviews and open questions as well as focus groups

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Countries of Recruitment

  •   Kazakhstan
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2019/04/01
  •   4000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   69   Years
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Additional Inclusion Criteria

Ability to follow the study procedures and provision of signed informed consent

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Exclusion Criteria

ever diagnosed alcohol dependency (lifetime) according to ICD 10

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf - Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Department of Public Health of Pavlodar Region
    • Isa Bayzaqov St. 152/1
    • 140000  Pavlodar
    • Kazakhstan
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    • Kazakh National Medical University „S.D. Asfendiyarov“ (KNMU)
    • 88 Tole Bi St.
    • 05000  Almaty
    • Kazakhstan
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    • Universitätsklinikum Hamburg-Eppendorf - Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg
    • Mr.  PD Dr.  Uwe  Verthein 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Monitoring Center on Alcohol and Drugs
    • Mr.  Oleg  Yussopov 
    • 78 Krupskaya Street 45
    • 14000  Pavlodar
    • Kazakhstan
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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    • Department of Public Health of Pavlodar Region
    • Isa Bayzaqov St. 152/1
    • 140000  Pavlodar
    • Kazakhstan
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Status

  •   Recruiting complete, follow-up complete
  •   2020/02/12
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Trial Publications, Results and other Documents

  •   Study Protocol
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* This entry means the parameter is not applicable or has not been set.