Table 1

Time points with corresponding measurements

Time pointMeasurements
Tx (during GP recruitment)1. GP characteristics:

  • Age, sex

  • Experience as a GP (years)

  • Practice type (solo, group)

  • Region (rural/urban/suburb)

  • Physician drug dispensing (yes/no)

Tx (during GP recruitment)2. GP characteristics:

  • Age, sex

  • Experience as a GP (years)

  • Practice type (solo, group)

  • Region (rural/urban/suburb)

  • Physician drug dispensing (yes/no)

T0 (immediately after the initial consultation)1. Patient characteristics:

  • Age, sex

  • List of drugs taken (incl. “as needed” drugs)

  • Living situation (at home, in a nursing home)


2. BSH treatment (name, defined daily dose, since when)

  • Willing to change, that is,

    • to stop the BSH (defined by the ATC codes N05CD and N05CF)

    • to reduce the BSH (defined by at least 50% of the previous dosage, or by at least 50% of the DDD if switched to another BSH)

    • to switch to a non-BSH insomnia treatment

  • Willing to continue with the BSH treatment


3. SIS
4. TMT-A
5. DIA-S
6. ISI
7. GAD-7
8. EQ-5D-5L
Between T0 and T1 (to be documented immediately and summarised at T1)1. Falls

  • No Injury

  • Fracture leading to

    • ambulatory care (GP visit, ED visit)

    • hospitalisation

  • Other injury (excluding fractures), leading to

    • no utilisation of healthcare

    • ambulatory care (GP visit, ED visit)

    • hospitalisation


2. Other events

  • Onjury (not resulting from a fall)

    • no utilisation of healthcare

    • ambulatory care (GP visit, ED visit)

    • hospitalisation

  • Episode of anxiety (as perceived by the patient)

    • no utilisation of healthcare

    • ambulatory care (GP visit, ED visit)

    • hospitalisation

  • Episode of depression (as perceived by the patient)

    • no utilisation of healthcare

    • ambulatory care (GP visit, ED visit)

    • hospitalisation

  • Episode of confusion (as perceived by the patient)

    • no utilisation of healthcare

    • ambulatory care (GP visit, ED visit)

    • hospitalisation

  • Hospitalisation not due to injury, fracture, anxiety or depression

  • Death (as a safety outcome)

T1 (6 months after the patient’s initial consultation)1. Current BSH intake (name, defined daily dose)

  • Continued since study entry (no change)

  • Re-started with the BSH after initial change


2. No or reduced current BSH intake compared with T0

  • No current intake of BSH

    • stopped the BSH, no alternative treatment

    • switched to a non-BSH insomnia treatment since the initial consultation (T0)

  • reduced the BSH (defined by at least 50% of the previous dosage, or by at least 50% of the DDD if switched to another BSH)


3. SIS
4.TMT-A
5. DIA-S
6. ISI
7. GAD-7
8. EQ-5D-5L
9. Follow-up phone calls with patients to evaluate the implementation issues and asses any clinical events
T2 (14 months after the initial consultation of a GP’s first patient)1. Qualitative measurements (questionnaires) among
GPs in the intervention group:

  • Barriers

  • Facilitators


2. Implementation measurements: GP questionnaires/no of dropouts at different time points of the study (see figure 1) and other issues according to the RE-AIM framework (see chapter 3)

  • ATC, Anatomical Therapeutic Chemical; BSH, benzodiazepine/other sedative-hypnotic; DDD, Defined Daily Dose; DIAS, Depression in Old Age Scale; ED, emergency department; EQ-5D, European Quality of Life 5 Dimensions; GAD-7, General Anxiety Disorder-7; GDS-15, Geriatric Depression Scale, 15 item short form; GP, general practitioner; ISI, Insomnia Severity Index; RE-AIM, Reach, Effectiveness, Adoption, Implementation, Maintenance; SIS, Six-Item Screene; TMT-A, Trail-Making Test A.