The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial
Abstract Background Incorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform...
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Health Services Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12913-023-10231-1 |
| _version_ | 1797453384194719744 |
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| author | Megan S. Zhou Tanya Jain Nick Hardy Alejandro Perez-Segura Jasmine Hickman Laurey Leopold Kerry Qualliotine Raagini S. Yedidi Matthew Whetsell Lauren Broffman |
| author_facet | Megan S. Zhou Tanya Jain Nick Hardy Alejandro Perez-Segura Jasmine Hickman Laurey Leopold Kerry Qualliotine Raagini S. Yedidi Matthew Whetsell Lauren Broffman |
| author_sort | Megan S. Zhou |
| collection | DOAJ |
| description | Abstract Background Incorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. Methods We used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool—a short prompt for patients to provide information on treatment satisfaction and side effects—impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling. Results Compared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005). Conclusions Prompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment. Trial registration This trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023). |
| first_indexed | 2024-03-09T15:22:02Z |
| format | Article |
| id | doaj.art-07060ee67c314789ab9abe75b8ed1300 |
| institution | Directory Open Access Journal |
| issn | 1472-6963 |
| language | English |
| last_indexed | 2024-03-09T15:22:02Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj.art-07060ee67c314789ab9abe75b8ed13002023-11-26T12:44:27ZengBMCBMC Health Services Research1472-69632023-11-012311810.1186/s12913-023-10231-1The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trialMegan S. Zhou0Tanya Jain1Nick Hardy2Alejandro Perez-Segura3Jasmine Hickman4Laurey Leopold5Kerry Qualliotine6Raagini S. Yedidi7Matthew Whetsell8Lauren Broffman9Roman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncRoman Health Ventures IncAbstract Background Incorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. Methods We used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool—a short prompt for patients to provide information on treatment satisfaction and side effects—impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling. Results Compared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005). Conclusions Prompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment. Trial registration This trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023).https://doi.org/10.1186/s12913-023-10231-1Patient-reported outcomesPatient-reported experience measuresHealthcare quality improvementAdverse eventsSide effectsTelemedicine |
| spellingShingle | Megan S. Zhou Tanya Jain Nick Hardy Alejandro Perez-Segura Jasmine Hickman Laurey Leopold Kerry Qualliotine Raagini S. Yedidi Matthew Whetsell Lauren Broffman The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial BMC Health Services Research Patient-reported outcomes Patient-reported experience measures Healthcare quality improvement Adverse events Side effects Telemedicine |
| title | The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial |
| title_full | The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial |
| title_fullStr | The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial |
| title_full_unstemmed | The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial |
| title_short | The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial |
| title_sort | design implementation and impact of an automated patient reported outcome data collection and adverse event surveillance tool a randomized trial |
| topic | Patient-reported outcomes Patient-reported experience measures Healthcare quality improvement Adverse events Side effects Telemedicine |
| url | https://doi.org/10.1186/s12913-023-10231-1 |
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