Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Buea | OTHER |
Not provided
Not provided
Not provided
Not provided
After being admitted to and then discharged from a hospital in Cameroon for having experienced an injury, there is no established way for the health system to check in on how the discharged person is doing. The investigators have developed a set of questions with the hope that asking these questions--over the phone--to those who have been discharged from the hospital will allow them to determine which post-discharge patients would benefit from further care. The investigators believe that asking these questions over the phone is a good way of determining which post-discharge trauma patients would benefit from further care.
Broadly, this study aims to answer three questions. (1) Is it feasible to call discharged trauma patients on their mobile phones to check up on them? (2) Can a defined set of questions help determine which discharged trauma patients require further medical care (and which discharged trauma patients do not require further medical care)? (3) Will checking in on discharged trauma patients reduce their experience of disability and economic consequences?
If an individual was a trauma patient who was admitted at and then discharged from one of the study's partner hospitals in Cameroon, the discharged individual (hereafter referred to as "the participant') will be receiving phone calls from one of the study's research assistants at the following post-discharge timepoints: 2 weeks, 1 month, 3 months, and 6 months. Whether the research assistant administers the defined set of questions developed by the study's investigators (see question 2, above) will depend on when the participant was discharged from the hospital. Regardless, all participants will be asked other important questions about the injury and any associated disabilities and economic consequences.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Mobile Phone-administered Triage Tool | No Intervention | For each hospital site: Baseline data will be collected for six months. **This extended beyond 6 months due to the COVID pandemic*** | |
| Mobile Phone-administered Triage Tool | Experimental | For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or "Mobile Phone-based Triage Tool") will be implemented for a year. **This extended beyond 1 year due to the COVID pandemic*** |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Phone-based Triage Tool | Other | The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Successful Contacts | The number of successful contacts will be divided by the total number of contacts. A "successful" contact is when an enrolled patient answered the phone, and consented to the research assistant administering the questionnaire(s) planned for that phone call. | 2 weeks after enrollment |
| Median Number of Attempts Required to Achieve a Successful Contact | This is the median number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call. | 2 weeks after enrollment |
| Median Cost Associated With Personnel Time | This measure is median monthly costs incurred to pay the research assistant for the time s/he spends making the required phone calls per patient. | At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID)) |
| Median Cost Associated With Telephone Time | This measure is the median costs incurred to make phone calls per patient in each study phase. | At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID)) |
| Telephone Triage Tool Administration Time | This measure will be calculated based on how much time it takes to administer the telephone triage tool. | After administration of the telephone triage tool (i.e. about 2 weeks after enrollment) |
| Physician Assessment of Whether a Patient Would Benefit From Further Services | This is a binary measure. After a physician examines a participant, s/he will determine whether s/he thinks the participant would benefit from further services (including additional follow-up care, and/or diagnostic or therapeutic interventions). |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcomes Scale-Extended (GOSE) Disability Level | The GOSE disability level that participants in the study report. For each participant, GOSE disability level will be determined using the augmented GOSE (aGOSE) instrument, which assesses factors like the participant's independence inside and outside the home, work, social and leisure activities, family and friendship, etc. Each time after administration of the aGOSE instrument, the participant's GOSE disability level will be calculated. The aGOSE score is reported for the 2-week post-discharge timepoint. The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories (worse to best respectively): Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) which was used in this study provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Juillard, MD, MPH | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laquintinie Hospital | Douala | Cameroon | ||||
| Edea Regional Hospital |
De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment occurred between August 5, 2019 and August 31, 2022. The baseline phase transitioned to intervention phase on Feb 16, 2020 at the 1st hospital with the planned step-wedge design. However, due to COVID restrictions in Cameroon to ensure participant safety, the study returned to baseline on April 27, 2020 and intervention phase restarted on Sep 7, 2020 while scrapping stepwedge design. Due to low recruitment numbers in COVID, study period was extended beyond the pre-specified 1 year.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Mobile Phone-administered Triage Tool | For each hospital site: Baseline data will be collected for six months. **This extended beyond 1 year due to the COVID pandemic*** |
| FG001 | Mobile Phone-administered Triage Tool | For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or "Mobile Phone-based Triage Tool") will be implemented for a year. **This extended beyond 1 year due to the COVID pandemic*** Mobile Phone-based Triage Tool: The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Mobile Phone-administered Triage Tool | For each hospital site: Baseline data will be collected for six months. **This extended beyond 6 months due to the COVID pandemic*** |
| BG001 | Mobile Phone-administered Triage Tool |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing data: Information not provided, missing data not included in the analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Successful Contacts | The number of successful contacts will be divided by the total number of contacts. A "successful" contact is when an enrolled patient answered the phone, and consented to the research assistant administering the questionnaire(s) planned for that phone call. | Posted | Count of Participants | Participants | 2 weeks after enrollment |
|
At the 2 weeks post-discharge phone call.
During an answered post-discharge phone call, respondents were asked on the survey if injured patient was alive.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Mobile Phone-administered Triage Tool | For each hospital site: Baseline data will be collected for six months. **This extended beyond 6 months due to the COVID pandemic*** |
Not provided
Not provided
Early in the COVID pandemic due to restrictions in Cameroon and to ensure safety of participants, changes were made such as pausing intervention phase where patients were asked to return to the hospital for a physician exam to cross-validate the telephone triage tool and reverting to baseline. The step-wedge design was also scrapped as this was disrupted by the pause. Low recruitment numbers in COVID also accounted for the intervention phase to be extended beyond the pre-specified timeline.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Juillard | University of California Los Angeles | 310-267-9609 | cjuillard@mednet.ucla.edu |
Not provided
| 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 | May 13, 2020 | Feb 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2019 | Feb 15, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
None of the interventional study model categories aptly describe the study. The step-wedge design of the study means each site has historical controls; the only thing determining whether an individual receives the intervention or not is time (that is, whether the hospital site s/he was admitted to happens to be in the pre-intervention/baseline data collection phase or the intervention phase).
Not provided
Not provided
Not provided
Not provided
|
| Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment) |
| Physician Assessment of Whether a Patient Was at Moderate to High Risk for a Poor Outcome (HR) Without Additional Intervention | After a physician examines a participant, s/he will determine whether s/he thinks the participant is at low, moderate or high risk for a poor outcome (HR) without additional intervention using subjective clinical assessment. | Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment) |
| Triage Risk Score (TRS) | To develop a sensitive model capable of risk stratifying triaged patients for high risk (HR), all candidate questions from the telephone triage tool found to associate with HR on univariate regression were weighted by their predictive coefficient and added to generate a triage risk score (TRS) ranging from a minimum score of 0 (lowest risk) to a maximum possible score of 43.9 (highest risk). Triage Risk Score (TRS) less than or equal to 1.3 (1st quartile) was designated as low risk, TRS 1.4 to 4.0 (2nd & 3rd quartile) as moderate risk, and TRS greater than or equal to 4.1 (fourth quartile) as high risk. | At the end of intervention phase (about 1 year after enrollment). |
| Acceptability Score of Mobile Phones as a Follow-up Tool | This is a numerical measure that represents the sum of the positive responses that participants give to each question that assesses the acceptability of mobile phones as a follow-up tool. The scale for the acceptability score of mobile phones as a follow-up tool ranges from 0 to 6, where 0 means the participant's responses indicate the participant believes mobile phones are definitely not an acceptable follow-up tool and 6 means the participant's responses indicate the participant believes mobile phones are definitely an acceptable follow-up tool. | 2 weeks after enrollment |
| Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation | This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who seek any clinical follow-up evaluation at the 2 weeks post-discharge phonecall. | After the 2week post-discharge phonecall. |
| At the 2week post-discharge telephone phonecall. |
| Economic Consequences of Injury: Did it Become More Difficult for the Family to Afford Expenses Such as Food and Rent? | Participants were asked if following the injury it became more difficult for the family to afford expenses such as food and rent. | At the 2week post-discharge telephone phonecall. |
| Economic Consequences of Injury: Did the Family Spend Saved Money? | Participants were asked if following the injury the family had to spend their savings. | At the 2week post-discharge telephone phonecall. |
| Economic Consequences of Injury: Did the Family Borrow Money? | Participants were asked if following the injury the family had to borrow money to meet up with expenses. | At the 2week post-discharge telephone phonecall. |
| Edéa |
| Cameroon |
| Limbé Regional Referral Hospital | Limbe | Cameroon |
| Pouma Catholic Hospital | Pouma | Cameroon |
For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or "Mobile Phone-based Triage Tool") will be implemented for a year.
**This extended beyond 1 year due to the COVID pandemic***
Mobile Phone-based Triage Tool: The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury.
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Missing data: Information not provided, missing data not included in the analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Education | Missing data: Information not provided, missing data not included in the analysis. | Count of Participants | Participants |
|
| Occupation | Missing data: Information not provided, missing data not included in the analysis. | Count of Participants | Participants |
|
| Study site | Count of Participants | Participants |
|
| Injury location | Missing data: Information not provided, missing data not included in the analysis. | Count of Participants | Participants |
|
| Injury mechanism | Missing data: Information not provided, missing data not included in the analysis. | Count of Participants | Participants |
|
|
|
| Primary | Median Number of Attempts Required to Achieve a Successful Contact | This is the median number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call. | There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Median | Inter-Quartile Range | Number of calls | 2 weeks after enrollment |
|
|
|
| Primary | Median Cost Associated With Personnel Time | This measure is median monthly costs incurred to pay the research assistant for the time s/he spends making the required phone calls per patient. | Posted | Median | Inter-Quartile Range | Dollars | At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID)) |
|
|
|
| Primary | Median Cost Associated With Telephone Time | This measure is the median costs incurred to make phone calls per patient in each study phase. | Posted | Median | Inter-Quartile Range | Dollars | At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID)) |
|
|
|
| Primary | Telephone Triage Tool Administration Time | This measure will be calculated based on how much time it takes to administer the telephone triage tool. | Telephone triage tool was the "intervention" and was only administered in the intervention phase. There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Median | Inter-Quartile Range | seconds | After administration of the telephone triage tool (i.e. about 2 weeks after enrollment) |
|
|
|
| Primary | Physician Assessment of Whether a Patient Would Benefit From Further Services | This is a binary measure. After a physician examines a participant, s/he will determine whether s/he thinks the participant would benefit from further services (including additional follow-up care, and/or diagnostic or therapeutic interventions). | Physician examination occurred only in the intervention phase where participants who were administered the telephone triage tool were asked to return for a physician examination to cross-validate tool finding. The number analyzed represents the number of patients who returned for the physician examination. | Posted | Count of Participants | Participants | Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment) |
|
|
|
| Primary | Physician Assessment of Whether a Patient Was at Moderate to High Risk for a Poor Outcome (HR) Without Additional Intervention | After a physician examines a participant, s/he will determine whether s/he thinks the participant is at low, moderate or high risk for a poor outcome (HR) without additional intervention using subjective clinical assessment. | Physician examination occurred only in the intervention phase where participants who were administered the telephone triage tool were asked to return for a physician examination to cross-validate tool finding. The number analyzed represents the number of patients who returned for the physician examination. | Posted | Count of Participants | Participants | Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment) |
|
|
|
| Primary | Triage Risk Score (TRS) | To develop a sensitive model capable of risk stratifying triaged patients for high risk (HR), all candidate questions from the telephone triage tool found to associate with HR on univariate regression were weighted by their predictive coefficient and added to generate a triage risk score (TRS) ranging from a minimum score of 0 (lowest risk) to a maximum possible score of 43.9 (highest risk). Triage Risk Score (TRS) less than or equal to 1.3 (1st quartile) was designated as low risk, TRS 1.4 to 4.0 (2nd & 3rd quartile) as moderate risk, and TRS greater than or equal to 4.1 (fourth quartile) as high risk. | The telephone triage tool was administered only in the intervention phase. The number analyzed represents the subset of patients who returned for the physician examination. | Posted | Count of Participants | Participants | At the end of intervention phase (about 1 year after enrollment). |
|
|
|
| Primary | Acceptability Score of Mobile Phones as a Follow-up Tool | This is a numerical measure that represents the sum of the positive responses that participants give to each question that assesses the acceptability of mobile phones as a follow-up tool. The scale for the acceptability score of mobile phones as a follow-up tool ranges from 0 to 6, where 0 means the participant's responses indicate the participant believes mobile phones are definitely not an acceptable follow-up tool and 6 means the participant's responses indicate the participant believes mobile phones are definitely an acceptable follow-up tool. | The acceptability tool was administered to a subset of patients. | Posted | Count of Participants | Participants | 2 weeks after enrollment |
|
|
|
| Primary | Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation | This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who seek any clinical follow-up evaluation at the 2 weeks post-discharge phonecall. | There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Count of Participants | Participants | After the 2week post-discharge phonecall. |
|
|
|
| Secondary | Glasgow Outcomes Scale-Extended (GOSE) Disability Level | The GOSE disability level that participants in the study report. For each participant, GOSE disability level will be determined using the augmented GOSE (aGOSE) instrument, which assesses factors like the participant's independence inside and outside the home, work, social and leisure activities, family and friendship, etc. Each time after administration of the aGOSE instrument, the participant's GOSE disability level will be calculated. The aGOSE score is reported for the 2-week post-discharge timepoint. The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories (worse to best respectively): Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) which was used in this study provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category. | There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Count of Participants | Participants | At the 2week post-discharge telephone phonecall. |
|
|
|
| Secondary | Economic Consequences of Injury: Did it Become More Difficult for the Family to Afford Expenses Such as Food and Rent? | Participants were asked if following the injury it became more difficult for the family to afford expenses such as food and rent. | There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Count of Participants | Participants | At the 2week post-discharge telephone phonecall. |
|
|
|
| Secondary | Economic Consequences of Injury: Did the Family Spend Saved Money? | Participants were asked if following the injury the family had to spend their savings. | There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Count of Participants | Participants | At the 2week post-discharge telephone phonecall. |
|
|
|
| Secondary | Economic Consequences of Injury: Did the Family Borrow Money? | Participants were asked if following the injury the family had to borrow money to meet up with expenses. | There was missing data for this variable hence the discrepancy between the overall number of participants analyzed for this variable and participants in the study. Missing data were dropped from the analysis. | Posted | Count of Participants | Participants | At the 2week post-discharge telephone phonecall. |
|
|
|
| 40 |
| 1,491 |
| 0 |
| 1,491 |
| 0 |
| 1,491 |
| EG001 | Mobile Phone-administered Triage Tool | For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or "Mobile Phone-based Triage Tool") will be implemented for a year. **This extended beyond 1 year due to the COVID pandemic*** Mobile Phone-based Triage Tool: The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury. | 49 | 2,499 | 0 | 2,499 | 0 | 2,499 |
Not provided
Not provided
| Secondary/High School |
|
| Tertiary-University |
|
| Other |
|
| Self-Employed |
|
| Student |
|
| Unemployed (able to work) |
|
| Unemployed (unable to work) |
|
| Retired |
|
| Other |
|
| Edea Regional Hospital |
|
| Limbe Regional Hospital |
|
| Road/Highway |
|
| Trade/Service Area |
|
| Industrial Construction |
|
| Other |
|
| Struck/hit by person |
|
| Fall |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Score of 3 |
|
| Score of 4 |
|
| Score of 5 |
|
| Score of 6 |
|
| Upper moderate disability |
|
| Lower moderate disability |
|
| Upper severe disability |
|
| Lower severe disability |
|
| Vegetative State |
|
| Death |
|