Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial
Abstract Background Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. In the ambulatory setting, this practice is particularly common in patients with malignancy due to anemia associated with thei...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-03-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1873-z |
| _version_ | 1819228525400424448 |
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| author | Dennis H. Murphree Theresa N. Kinard Nandita Khera Curtis B. Storlie Che Ngufor Sudhindra Upadhyaya Jyotishman Pathak Emma Fortune Eapen K. Jacob Rickey E. Carter Karl A. Poterack Daryl J. Kor |
| author_facet | Dennis H. Murphree Theresa N. Kinard Nandita Khera Curtis B. Storlie Che Ngufor Sudhindra Upadhyaya Jyotishman Pathak Emma Fortune Eapen K. Jacob Rickey E. Carter Karl A. Poterack Daryl J. Kor |
| author_sort | Dennis H. Murphree |
| collection | DOAJ |
| description | Abstract Background Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. In the ambulatory setting, this practice is particularly common in patients with malignancy due to anemia associated with their cancer therapy. Increasingly, the efficacy of this US$10.5 billion per year practice has been called into question. While it is often standard of care for patients with chemotherapy-induced anemia to receive ambulatory RBC transfusions, it is unclear to what extent such transfusions affect home functional status. It is also unclear whether or not changes in functional status in this population can be objectively quantified using wearable activity monitors. We propose to directly measure the impact of outpatient RBC transfusions on at-home functional status by recording several physiological parameters and quantifiable physical activity metrics, e.g., daily energy expenditure and daily total step count, using the ActiGraph wGT3X-BT. This device is an accelerometer-based wearable activity monitor similar in size to a small watch and is worn at the waist. Study participants will wear the device during the course of their daily activities giving us quantifiable insight into activity levels in the home environment. Methods/design This will be a randomized crossover pilot clinical trial with a participant study duration of 28 days. The crossover nature allows each patient to serve as their own control. Briefly, patients presenting at a tertiary medical center’s Ambulatory Infusion Center (AIC) will be randomized to either: (1) receive an RBC transfusion as scheduled (transfusion) or (2) abstain from the scheduled transfusion (no transfusion). After an appropriate washout period, participants will crossover from the transfusion arm to the no-transfusion arm or vice versa. Activity levels will be recorded continuously throughout the study using an accelerometry monitor. In addition to device data, functional status and health outcomes will be collected via a weekly telephone interview. The primary outcome measure will be daily energy expenditure. Performance metrics, such as step count changes, will also be evaluated. Additional secondary outcome measures will include daily sedentary time and Patient-reported Outcomes Measurement Information System (PROMIS) Global 10 Survey scores. Discussion This trial will provide important information on the feasibility and utility of using accelerometry monitors to directly assess the impact of RBC transfusion on patients’ functional status. The results of the study will inform the merit and methods of a more definitive future trial evaluating the impact of ambulatory RBC transfusions in the target population. Trial registration ClinicalTrials.gov, identifier: NCT02835937 . Registered on 15 July 2016. |
| first_indexed | 2024-12-23T10:58:40Z |
| format | Article |
| id | doaj.art-56e12abbf7944f7a9454f4b9ccf3f012 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-23T10:58:40Z |
| publishDate | 2017-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-56e12abbf7944f7a9454f4b9ccf3f0122022-12-21T17:49:42ZengBMCTrials1745-62152017-03-0118111010.1186/s13063-017-1873-zMeasuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trialDennis H. Murphree0Theresa N. Kinard1Nandita Khera2Curtis B. Storlie3Che Ngufor4Sudhindra Upadhyaya5Jyotishman Pathak6Emma Fortune7Eapen K. Jacob8Rickey E. Carter9Karl A. Poterack10Daryl J. Kor11Department of Health Sciences Research, Mayo ClinicDepartment of Pathology and Laboratory Medicine, Mayo ClinicDepartment of Hematology, Mayo ClinicDepartment of Health Sciences Research, Mayo ClinicDepartment of Health Sciences Research, Mayo ClinicDepartment of Health Sciences Research, Mayo ClinicDivision of Health Informatics, Weill Cornell Medical CollegeDepartment of Health Sciences Research, Mayo ClinicDivision of Hematology, Mayo ClinicDepartment of Health Sciences Research, Mayo ClinicDepartment of Anesthesiology, Mayo ClinicDepartment of Anesthesiology, Mayo ClinicAbstract Background Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. In the ambulatory setting, this practice is particularly common in patients with malignancy due to anemia associated with their cancer therapy. Increasingly, the efficacy of this US$10.5 billion per year practice has been called into question. While it is often standard of care for patients with chemotherapy-induced anemia to receive ambulatory RBC transfusions, it is unclear to what extent such transfusions affect home functional status. It is also unclear whether or not changes in functional status in this population can be objectively quantified using wearable activity monitors. We propose to directly measure the impact of outpatient RBC transfusions on at-home functional status by recording several physiological parameters and quantifiable physical activity metrics, e.g., daily energy expenditure and daily total step count, using the ActiGraph wGT3X-BT. This device is an accelerometer-based wearable activity monitor similar in size to a small watch and is worn at the waist. Study participants will wear the device during the course of their daily activities giving us quantifiable insight into activity levels in the home environment. Methods/design This will be a randomized crossover pilot clinical trial with a participant study duration of 28 days. The crossover nature allows each patient to serve as their own control. Briefly, patients presenting at a tertiary medical center’s Ambulatory Infusion Center (AIC) will be randomized to either: (1) receive an RBC transfusion as scheduled (transfusion) or (2) abstain from the scheduled transfusion (no transfusion). After an appropriate washout period, participants will crossover from the transfusion arm to the no-transfusion arm or vice versa. Activity levels will be recorded continuously throughout the study using an accelerometry monitor. In addition to device data, functional status and health outcomes will be collected via a weekly telephone interview. The primary outcome measure will be daily energy expenditure. Performance metrics, such as step count changes, will also be evaluated. Additional secondary outcome measures will include daily sedentary time and Patient-reported Outcomes Measurement Information System (PROMIS) Global 10 Survey scores. Discussion This trial will provide important information on the feasibility and utility of using accelerometry monitors to directly assess the impact of RBC transfusion on patients’ functional status. The results of the study will inform the merit and methods of a more definitive future trial evaluating the impact of ambulatory RBC transfusions in the target population. Trial registration ClinicalTrials.gov, identifier: NCT02835937 . Registered on 15 July 2016.http://link.springer.com/article/10.1186/s13063-017-1873-zTransfusionFunctional statusOutpatientClinical trial |
| spellingShingle | Dennis H. Murphree Theresa N. Kinard Nandita Khera Curtis B. Storlie Che Ngufor Sudhindra Upadhyaya Jyotishman Pathak Emma Fortune Eapen K. Jacob Rickey E. Carter Karl A. Poterack Daryl J. Kor Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial Trials Transfusion Functional status Outpatient Clinical trial |
| title | Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial |
| title_full | Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial |
| title_fullStr | Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial |
| title_full_unstemmed | Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial |
| title_short | Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial |
| title_sort | measuring the impact of ambulatory red blood cell transfusion on home functional status study protocol for a pilot randomized controlled trial |
| topic | Transfusion Functional status Outpatient Clinical trial |
| url | http://link.springer.com/article/10.1186/s13063-017-1873-z |
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