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The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies in both primary and secondary care resulting in one of the highest mortality rates in Europe. A key recommendation in the report is the provision of an annual asthma review in primary care.
Telehealthcare is an alternative means of service delivery incorporating the use of telephone and e-mail consultations which may improve access and quality of patient care. There is scant data on the role of teleheathcare in asthma care.
This is a single-centre, primary care-based, randomized controlled trial to evaluate the use of telehealthcare to conduct the annual asthma review for adult patients with well-controlled asthma. This will be compared with standard care (face-to-face consultations).
Telehealthcare will consist of a telephone consultation followed by an e-mail with an attached personalised asthma action plan and a link to a video demonstrating inhaler technique.
Standard care will involve a face-to-face consultation in primary care. The two patient groups will be compared prospectively to determine whether there is a difference in the quality of care evaluated in terms of the patient experience/ satisfaction, health-related quality of life, asthma control and frequency of asthma exacerbations over a 6 month period after the asthma review.
The data will be presented in the form of frequency tables, bar charts and pie charts. Non-parametric tests will be applied to determine whether there is a significant difference in the quality of care received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | Patients will receive a face-to-face asthma review | |
| Telehealthcare | Active Comparator | Patients will receive a telephone consultation and e-mail with attached PAAP and video link |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealthcare | Other | Telephone consultation plus e-mail with attached PAAP and video link |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score) | General Practice Assessment Questionnaire (GPAQ) is a widely used questionnaire to assess the patient experience of general practice in the UK. It is designed to measure satisfaction across four domains: communication (8 items), confidence (3 items), access to care (2 items) and overall satisfaction (2 items). Patients rate their experience by selecting not of usually 5 responses (1= very good to 5= very poor). Response items were linearly rescaled to a 0-100 range (100 = most favourable response). 'Does not apply' responses were excluded from the analysis. This yielded four median domain scores for each patient (range 0-100 per domain). An overall patient experience score was calculated for each patient by adding the four domain scores together to give a total score out of 400 (range 0-400). The median overall patient experience score (+/- interquartile range) was calculated for each group and the scores were compared (tele healthcare vs control) | Up to 2 weeks after the asthma review |
| Measure | Description | Time Frame |
|---|---|---|
| Dropout Rate | The dropout rate is the number of patients that failed to attend for an asthma review ('Did not attend', lost to follow up, or withdrew consent) in each patient group. | Baseline |
| Average Consultation Length (Time) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Glynne, MRCP MRCGP | Balham Park Surgery, Wandsworth CCG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balham Park Surgery | London | SW17 7AW | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Patients received a face-to-face asthma review |
| FG001 | Telehealthcare | Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Patients received a face-to-face asthma review |
| BG001 | Telehealthcare | Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score) | General Practice Assessment Questionnaire (GPAQ) is a widely used questionnaire to assess the patient experience of general practice in the UK. It is designed to measure satisfaction across four domains: communication (8 items), confidence (3 items), access to care (2 items) and overall satisfaction (2 items). Patients rate their experience by selecting not of usually 5 responses (1= very good to 5= very poor). Response items were linearly rescaled to a 0-100 range (100 = most favourable response). 'Does not apply' responses were excluded from the analysis. This yielded four median domain scores for each patient (range 0-100 per domain). An overall patient experience score was calculated for each patient by adding the four domain scores together to give a total score out of 400 (range 0-400). The median overall patient experience score (+/- interquartile range) was calculated for each group and the scores were compared (tele healthcare vs control) | Posted | Median | Inter-Quartile Range | score on a scale | Up to 2 weeks after the asthma review |
|
6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Patients received a face-to-face asthma review |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarah Glynne | Oxshott Medical Practice | 01372 844000 | sarah.glynne@nhs.net |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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The average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review
| Baseline |
| Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ)) | Quality of life will be assessed using the Asthma Quality of Life Questionnaire (AQLQ) in each group at the start of the study (before the asthma review) and 6 months after the asthma review. Asthma Quality of Life Questionnaire (AQLQ) is a valid, reliable questionnaire that measures the "functional problems" (physical, emotional, social and occupational) that are most troublesome to adults aged 17-70 years with asthma. For the purpose of this study, a 15-item mini-AQLQ was used, with scores ranging from 1 (severely impaired) to 7 (not impaired at all). The 6 month AQLQ score is presented in each group. The p value compares the change in AQLQ score from baseline to 6 months between the two groups. | Baseline and 6 months |
| Asthma Control Test Score | Assessment of asthma control using validated questionnaire at baseline (before the asthma review) and 6 months after the asthma review. The ACT score at 6 months is presented. The p value compares the change in ACT score from baseline to 6 months, in each group. Asthma Control Test (ACT) is a simple, five-item, validated questionnaire that is designed to identify patients (>12 years old) with poorly controlled asthma. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | 6 months after asthma review. |
| Number of Exacerbations. | Number of exacerbations (unscheduled asthma consultations in primary care, courses of systemic steroids, out of hour attendances, hospital admissions) in the six months after the asthma review in each group. | In the six months after the asthma review. |
| Future Preference | After the asthma review, patients were asked whether they would prefer a tele healthcare asthma review in future. Percentage of patients that expressed preference for THC review is presented. | Within 2 weeks of the asthma review. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Occupation | Number | participants |
|
| Median ACT score | Asthma Control Test (ACT) was used to screen patients for poor asthma control prior to study enrolment. This is a simple, five-item, validated questionnaire that is designed to identify patients (>12 years old) with poorly controlled asthma. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Median | Inter-Quartile Range | units on a scale |
|
| Median AQLQ score | Asthma Quality of Life Questionnaire (AQLQ) is a valid, reliable questionnaire that measures the "functional problems" (physical, emotional, social and occupational) that are most troublesome to adults aged 17-70 years with asthma. For the purpose of this study, a 15-item mini-AQLQ was used, with scores ranging from 1 (severely impaired) to 7 (not impaired at all). | Median | Inter-Quartile Range | units on a scale |
|
| Median length of time since last asthma review | Median | Inter-Quartile Range | months |
|
| OG000 | Standard Care | Patients received a face-to-face asthma review |
| OG001 | Telehealthcare | Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link. |
|
|
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| Secondary | Dropout Rate | The dropout rate is the number of patients that failed to attend for an asthma review ('Did not attend', lost to follow up, or withdrew consent) in each patient group. | Posted | Count of Participants | Participants | Baseline |
|
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|
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| Secondary | Average Consultation Length (Time) | The average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review | Posted | Median | Inter-Quartile Range | minutes | Baseline |
|
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|
| Secondary | Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ)) | Quality of life will be assessed using the Asthma Quality of Life Questionnaire (AQLQ) in each group at the start of the study (before the asthma review) and 6 months after the asthma review. Asthma Quality of Life Questionnaire (AQLQ) is a valid, reliable questionnaire that measures the "functional problems" (physical, emotional, social and occupational) that are most troublesome to adults aged 17-70 years with asthma. For the purpose of this study, a 15-item mini-AQLQ was used, with scores ranging from 1 (severely impaired) to 7 (not impaired at all). The 6 month AQLQ score is presented in each group. The p value compares the change in AQLQ score from baseline to 6 months between the two groups. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 6 months |
|
|
|
|
| Secondary | Asthma Control Test Score | Assessment of asthma control using validated questionnaire at baseline (before the asthma review) and 6 months after the asthma review. The ACT score at 6 months is presented. The p value compares the change in ACT score from baseline to 6 months, in each group. Asthma Control Test (ACT) is a simple, five-item, validated questionnaire that is designed to identify patients (>12 years old) with poorly controlled asthma. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after asthma review. |
|
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| Secondary | Number of Exacerbations. | Number of exacerbations (unscheduled asthma consultations in primary care, courses of systemic steroids, out of hour attendances, hospital admissions) in the six months after the asthma review in each group. | Posted | Median | Inter-Quartile Range | exacerbations | In the six months after the asthma review. |
|
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| Secondary | Future Preference | After the asthma review, patients were asked whether they would prefer a tele healthcare asthma review in future. Percentage of patients that expressed preference for THC review is presented. | Posted | Count of Participants | Participants | Within 2 weeks of the asthma review. |
|
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| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Telehealthcare | Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link. | 0 | 42 | 0 | 42 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |