OBJECTIVES: Current documentation methods for patients with skin and soft tissue infections receiving outpatientparenteral anti-infective therapy (OPAT) include written descriptions and drawings of the infection that may inadequately communicate clinical status. We undertook a study to determine whether photodocumentation (PD) improves the duration of outpatient treatment of skin and soft tissue infections. METHODS: A single-blinded, prospective, randomized trial was conducted in the emergency departments of a community hospital and an academic tertiary centre. Participants included consecutive patients age ≥ 14 years presenting with noninvasive skin and soft tissue infections requiring OPAT. Patients in the intervention arm were treated with standard of care plus PD at each emergency physician assessment. Control subjects received care provided at the discretion of the treating physician and non-photographic documentation. The primary outcome was duration of therapy measured in half-days. The required sample size to detect a difference of one half-day was 253 patients per group (α = 0.05). Secondary outcomes included (1) completion and therapeutic failure rates, (2) patient satisfaction, and (3) physician and nurse satisfaction. RESULTS: Enrolment was slower and follow-up rates lower than anticipated, and the trial was terminated when funds were exhausted. A total of 468 subjects with similar age and gender characteristics were enrolled, with 244 receiving the intervention and 224 in the control arm. The mean OPAT duration was similar in the two groups (3.6 days v. 3.5 days, p = 0.73). No differences in the rate for completion and therapeutic failure were observed (71% v. 68% and < 1% for both, respectively). Survey response rates varied significantly: patients, 65%; nurses, 17%; and physicians, 87%. Physicians endorsed more comfort with their assessment and OPAT judgment with PD (65% and 64%, respectively). Physicians cited too much time lost with technological challenges, which would affect implementation in a busy ED. CONCLUSIONS: PD as an intervention is acceptable to patients and has reasonable endorsement by the majority of physicians. This trial had significant limitations that threatened the integrity of the study, so the results are inconclusive.
RCT Entities:
OBJECTIVES: Current documentation methods for patients with skin and soft tissue infections receiving outpatient parenteral anti-infective therapy (OPAT) include written descriptions and drawings of the infection that may inadequately communicate clinical status. We undertook a study to determine whether photodocumentation (PD) improves the duration of outpatient treatment of skin and soft tissue infections. METHODS: A single-blinded, prospective, randomized trial was conducted in the emergency departments of a community hospital and an academic tertiary centre. Participants included consecutive patients age ≥ 14 years presenting with noninvasive skin and soft tissue infections requiring OPAT. Patients in the intervention arm were treated with standard of care plus PD at each emergency physician assessment. Control subjects received care provided at the discretion of the treating physician and non-photographic documentation. The primary outcome was duration of therapy measured in half-days. The required sample size to detect a difference of one half-day was 253 patients per group (α = 0.05). Secondary outcomes included (1) completion and therapeutic failure rates, (2) patient satisfaction, and (3) physician and nurse satisfaction. RESULTS: Enrolment was slower and follow-up rates lower than anticipated, and the trial was terminated when funds were exhausted. A total of 468 subjects with similar age and gender characteristics were enrolled, with 244 receiving the intervention and 224 in the control arm. The mean OPAT duration was similar in the two groups (3.6 days v. 3.5 days, p = 0.73). No differences in the rate for completion and therapeutic failure were observed (71% v. 68% and < 1% for both, respectively). Survey response rates varied significantly: patients, 65%; nurses, 17%; and physicians, 87%. Physicians endorsed more comfort with their assessment and OPAT judgment with PD (65% and 64%, respectively). Physicians cited too much time lost with technological challenges, which would affect implementation in a busy ED. CONCLUSIONS:PD as an intervention is acceptable to patients and has reasonable endorsement by the majority of physicians. This trial had significant limitations that threatened the integrity of the study, so the results are inconclusive.