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This study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. Additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | In the control pathway, the surgeons communicated with the family only once near the completion of the procedure. | |
| Intervention | Experimental | In the intervention group, the families received additional standardized electronic updates via pagers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative Updates | Other | In the intervention group, the families received additional standardized electronic updates via pagers at three pivotal moments: 1) Initial skin incision has been made; 2) Critical part of the case is completed and closure has begun; and, 3) Closure is complete, and patient will be transferred to the recovery room when ready. |
| Measure | Description | Time Frame |
|---|---|---|
| Likert Score (0-5) of level of overall satisfaction | Likert Score (0-5) of level of overall satisfaction of family members throughout the perioperative period | Overall satisfaction levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure. |
| Likert Score (0-5) of anxiety level | Likert Score (0-5) of anxiety level of family members throughout the perioperative period | Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure. |
| Likert Score (0-5) of level of satisfaction with perioperative updates | Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period | Satisfaction with perioperative updates measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Spearman correlation between length of procedure and Likert score of anxiety level | Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period | Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update. |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2016 | Mar 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Spearman correlation between length of procedure and Likert score of overall satisfaction | Spearman correlation between length of procedure and Likert score (0-5) of overall satisfaction level of family members throughout the perioperative period | Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update. |
| Spearman correlation between length of procedure and Likert score of satisfaction with perioperative updates | Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates | Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update. |