| Study characteristics |
| Methods |
Allocation: simple randomised sampling after PANSS assessment
Design: randomised controlled trial
Duration: 1 year and 3 months
Date of study: not specified
Country: India
Setting: single site, psychiatry ward of Lady Reading Hospital Peshawar
Recruitment method: referred by primary care providers immediately after starting antipsychotic medication for schizophrenia
Masking: double‐blind |
| Participants |
Inclusion criteria: none described, can assume “diagnosis of schizophrenia and on anti‐psychotic medication”
Exclusion criteria: evidence that the patient had received an antidepressant or antipsychotic, alone or in combination, in the preceding 6 months; comorbid mania or bipolar; psychotic symptoms; eminent suicidality; substance use disorder or dependence
Number randomised to intervention and control: 96 enrolled, 50 intervention, 46 control
Number completed study: 80
Age: intervention mean 36.9 (SD 10.1), control mean 37.3 (SD 10.2)
Sex: intervention 54.8%, control 56.1% female
Diagnosis: schizophrenia: intervention 78.2%, control 69.5%, schizoaffective: intervention 21.7%, control 30.4%
Ethnicity: not described
Any significant differences between intervention and control groups? There were no significant differences between the two groups with respect to age, gender, duration of illness, number of hospitalisations and number of months since the last hospitalisation.
Note ‐ demographics numbers do not add up.
|
| Interventions |
Type of collaborative care: B
Description of intervention:
Intervention name: collaborative care
Contains three elements of collaborative care:
Multi‐professional approach to patient care: no, psychiatrist and pharmacist care managers, liaison with clinical psychologists, does not meet criteria for a collaborative multi‐professional approach A structured management plan: yes, brief counselling on the prescribed drug, therapeutic endpoints and side effects. Participants were interviewed by care managers immediately after randomisation to assess the severity of psychopathology, identifying potential stressors and other predisposing factors. Past medication, surgical, medical and psychiatric histories were also recorded. Participants were also educated on positive, negative and general symptoms, aetiology and prognosis of schizophrenia. A detailed explanation of the role of antipsychotics was presented, including therapeutic benefits and side effects. Family members were actively engaged in this education. During visits, pharmacists followed standardised set of questions to assess drug adherence, therapeutic effects and outcomes, adverse effects and other social, psychological and medical factors. This enabled them to identify activities participants neglected during their illness and provide encouragement. Scheduled patient follow‐ups: yes, participants were scheduled for frequent follow‐up every 2 weeks, via telephone call and clinic appointments. Clinic visits were scheduled on week 2, 6, 12 and 24 for psychiatric follow‐ups where pharmacists would evaluate clinical progress. At week 12 necessity of treatment was determined. Enhanced interprofessional communication: yes ‐ clinical pharmacists met with the psychiatrist approximately daily for half an hour, 2 hours each week at least, summarising the presentation of new patients with the psychologist's assistance, as well as providing updates on the clinical progress of other subjects, and discussing it with the head clinical psychologists in the ward.
Other intervention components:
Control group:
Enhanced usual care: participants were provided with diary cards as a medication adherence reminder |
| Outcomes |
Measures taken at: baseline, 3 and 6 months
Primary outcome: fails to report which outcomes are considered primary or secondary
Able to use:
Symptoms (Positive and Negative Symptoms Scale – PANSS) (baseline and 6 months) Quality of life (Short Form 12 ‐ SF‐12) (baseline and 6 months) Attrition (number lost to follow‐up) (6 months)
Unable to use:
Medication adherence: Morisky Medication Adherence Scale (MMAS‐4) (baseline and 6 months) ‐ see notes Medication Adherence (Medication Adherence Report Scale ‐ MARS) (baseline and 6 months) ‐ see notes Patient satisfaction with pharmacy services: (14‐item 5‐point Likert scale of statements, unvalidated) – (3 months)
|
| Notes |
Note: Demographics numbers do not add up.
We excluded the MARS and the MMAS medication adherence measures as the reported results were both outside of the possible range of values that could be observed using these measures, and we did not receive any clarification from the authors. |
