Here is the design of a clinical trial:

Official Title: Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial

Included conditions:
- Critical Illness

Study Armgroups:
- {'label': 'Nutrition Education Program', 'type': 'EXPERIMENTAL', 'description': 'Nutrition education for family members of an elderly critically ill patient', 'interventionNames': ['Behavioral: Nutrition Education Program']}
- {'label': 'Decision Support Program', 'type': 'EXPERIMENTAL', 'description': 'Decision support education for family members of an elderly critically ill patient', 'interventionNames': ['Other: Decision Support Program']}
- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Nutrition Education Program', 'description': "* The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention\n* Nutritional education will be provided to ICU patents' families by a dietitian\n* Tracking of nutritional information by family\n* Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day)", 'armGroupLabels': ['Nutrition Education Program'], 'otherNames': ['OPTICS']}
- {'type': 'OTHER', 'name': 'Decision Support Program', 'description': '* Families will be provided with a web-based decision support tool (My ICU Guide)\n* Families will meet with the ICU medical team early in ICU stay to review goals of care', 'armGroupLabels': ['Decision Support Program'], 'otherNames': ['The REALISTIC-80 Decision Support Intervention', 'My ICU Guide']}

Primary Outcomes:
- {'measure': 'Nutritional adequacy during the ICU stay', 'timeFrame': 'Up to 30 days in ICU'}
- {'measure': 'Consumption of Oral Nutritional Supplements', 'timeFrame': 'First four weeks once on ward'}
- {'measure': 'Intake on hospital wards (3 day calorie count)', 'timeFrame': 'First four weeks once on ward'}
- {'measure': 'Hand grip strength', 'description': 'Hydraulic hand dynamometer', 'timeFrame': 'At or before hospital discharge or up to 90 days'}
- {'measure': 'Use of shared-decision making (OPTION tool)', 'timeFrame': 'Within first week in ICU'}
- {'measure': 'Change in decisional conflict', 'description': '10-item Decisional Conflict Scale', 'timeFrame': '1 week'}
- {'measure': 'Family satisfaction with decision-making', 'timeFrame': '1 week'}
- {'measure': 'Overall family satisfaction with ICU', 'timeFrame': 'At ICU discharge, an average of 12 days'}

Please estimate the sample size based on the assumption: 
50 patients per group will achieve 92% power at a two-sided alpha = 0.05 for nutritional adequacy. For the decision-support intervention, 50 evaluable subjects per group will achieve 71% power at a two-sided alpha = 0.05 to detect a 5.5-point difference. A sample size of 50 per group allows for reasonable precision in assessing feasibility, compliance, and contamination endpoints.
Sample size
        The total sample size for this phase II trial is 150 patients (50 per group). We expect the subsequent phase III trial will require 20â30 sites with up to 1000 patients in total. As one of the primary goals of this phase II trial is to assess the feasibility of implementing the study interventions, we plan to assess feasibility at multiple sites. With approximately 10â20 patients per site, we expect to gain enough experience to assess the feasibility of the study protocol per site.
        For each intervention, we have performed a sample size calculation for one of the key short-term outcomes of each intervention. From our prior work, we know that the average nutritional adequacy of these patients during their ICU stay will be 40â50% with a standard deviation of 30% [36]. We aim to detect a small but clinically meaningful increase in nutritional adequacy of approximately 20%. Under these assumptions 50 patients per group will achieve 92% power at a two-sided alphaâ=â0.05. For the decision-support intervention, we will power the trial to evaluate family satisfaction with decision-making. In our prior REALISTIC-80 study, the standard deviation of the FS-ICU24 âDecision-makingâ domain was 11; we consider an increase of 5.5 points (a medium effect size) to be plausible and clinically important. With 50 evaluable subjects per group, we would achieve 71% power at a two-sided alphaâ=â0.05 to detect a 5.5-point difference between groups.
        Given the other objectives of the study related to feasibility, compliance, and contamination, a sample size of 50 per group will allow us to assess these endpoints with reasonable precision, consistent with the sample size of other phase II studies. For example, with 50 patients per group there is a 95% chance of estimating a binary variable (such as loss to follow-up, contamination, compliance, etc.) to withinâÂ±â14% and any variable with a rateâ<â15% orâ>â85% (as would be expected for loss to follow-up, contamination, or compliance) could be estimated to withinâÂ±â10% or 19 times out of 20.