Routine Outcome Monitoring for Geriatric Psychiatry & Science 2.0

Affective disorders, encompassing depressive-, anxiety-, and somatic symptom
disorders, are the most prevalent mental disorders in later life. These
disorders are often comorbid to each other and have limited diagnostic
stability over time. Treatment protocols and guidelines in geriatric psychiatry
largely rely on evidence from randomized controlled trials (RCTs) conducted in
younger age samples and ignore comorbidity between these disorders. Moreover,
the few studies conducted in older samples are often limited to the *younger
old* and rarely include the most frail. Therefore, the effectiveness of
treatment for late-life affective disorders is largely unknown in routine
clinical care, as is the impact of age-specific characteristics.

The primary aim of the Routine Outcome Monitoring for Geriatric Psychiatry &
Science 2.0 project (ROM-GPS 2.0) is 1) to evaluate treatment outcome for
affective disorders in specialised geriatric mental health care and 2) to
examine the impact of age-specific characteristics on the effectiveness.

Multicentre, longitudinal, observational study in specialised geriatric mental
health care. All participating outpatient clinics have harmonized their intake
procedures, including a protocolized diagnostic assessment including a
well-validated psychiatric diagnostic interview (MINI). Eligible patients will
be asked consent for full participation in the study, and if refused, for
limited participation. Full participation consists of an extensive baseline and
one-year follow-up assessment (site-visits) to evaluate treatment outcome over
the first year of mental health care and two postal questionnaires at 4 and 8
months. For limited participation, we ask consent to extract routine clinical
data from the patient*s electronic record and filling out a postal outcome
questionnaire at one year.

In addition to routine clinical care (including a semi-structured diagnostic
psychiatric interview as part of the harmonized and protocolized intake)
informed consent will be asked for data extraction from the medical record
(treatment characteristics) and filling out a brief outcome questionnaire after
one year (~15 minutes) in case of limited participation. In case of full
participation, additional consent is asked for 1) an extensive baseline
assessment including self-report questionnaires, a physical examination and
cognitive testing (~180 minutes), 2) an outcome assessment after one year
including all baseline measures amenable to change (~180 minutes), and 3) two
postal self-report questionnaires at 4 and 8 months (each ~15 minutes).
The patient burden in case of full participation consists of two additional
(half-day) visits to the hospital. The risks of filling in the questionnaires
as well as the physical examination and cognitive tests is negligible as all
assessments have been validated for older people and are commonly used in
routine clinical care and monitoring studies.
Observational data of routine clinical care in geriatric mental health care is
of utmost relevance as older patients are often excluded from RCTs trials,
especially those who suffer from multimorbidity, frailty or age-related
cognitive decline (who are mostly seen in clinical practice). Such data cannot
be studied in healthy volunteers.