Table 1.
Phase of study | Problems | Changes implemented |
---|---|---|
Screening | Difficulty maintaining contact with po- tentially eligible participants |
Interviewed potential participants in the hospital as soon as possible after admission |
Informed consent | Unfamiliarity with research; suspi- ciousness |
Lengthy discussion of consent, administered brief quiz to check un- derstanding before consent |
Randomization | Negative reaction to TAU assignment | Assignment of study case managers to provide support and referrals |
Completing baseline interview | Poor concentration | Use of open-ended questions; interviews conducted after medica- tions stabilized |
Follow-up | Difficulty maintaining contact | Detailed locator interview at each assessment; community voice- mail; study case managers maintained frequent contact; tokens pro- vided for appointments |
Therapy attendance | Poor attendance; inability to attend ses- sions on time |
First session conducted while still in hospital; one established week- ly time per patient; full-time therapists available for “walk-in” ses- sions |