ORCHARD- Optimising Home Assessment of Rural Patients

Study Overview
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Brief Summary
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This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. COVID-19 has caused an upsurge in primary care telemedicine which the investigators believe can be sustained and optimized to make things better for medically vulnerable rural patients beyond the pandemic. The investigators will achieve this by equipping the participants to self-measure and report key clinical measurements (e.g. blood pressure, temperature, oxygen levels) during telemedicine consultations. Before conducting a major evaluation of the Medical-Self-Assessment-Box for medically vulnerable rural patients the investigators must establish three things: First, to show the investigators can issue a Medical-Self-Assessment-Box to medically vulnerable rural patients and enable them to use it properly. Second, to determine that patients can use the Medical-Self-Assessment-Box effectively during telemedicine consultations. Third, to show that it is possible to measure how well the Medical-Self-Assessment-Box is working by counting how often the boxes are being used and whether use is appropriate and helpful. The knowledge gained will provide the investigators with the information needed to develop a funding proposal to evaluate Medical-Self-Assessment-Boxes for medically vulnerable rural patients in the whole of the UK.

Official Title
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Optimising Remote Consulting and Home Assessment of Medically Vulnerable Rural Patients During Unscheduled and Planned Primary Care- Assessing Feasibility of the ORCHARD Intervention

Conditions
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Organ Transplant, Cancer, Inborn Errors of Metabolism, Immunosuppression, COPD Asthma, Sickle Cell Disease

Intervention / Treatment
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* Device: A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ● Solid organ transplant recipient On the COVID-19 shielding list People with specific cancers People with cancer who had chemotherapy within the last 2 years People with lung cancer that have had radical radiotherapy within the last two years People with cancer of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at end stage treatment People that have had immunotherapy or other continuing antibody treatments for cancer within the last two years People that had other targeted cancer treatment which can affect the immune system, such as protein kinase inhibitors or PARP inhibitors within the last two years People who had bone marrow or stem cell transplants in the last 6 months, or who are still taking immunosuppression drugs People with severe respiratory conditions including all cystic fibrosis, severe asthma, and severe COPD People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as SCID, homozygous sickle cell anaemia) People in immunosuppression therapies sufficient to significantly increase risk of infection Inclusion criteria for GPs: A GP working at the pilot study practice and carried out telemedicine consultations with participants A GP who can provide informed consent Exclusion Criteria: People whose GP feels they are not able to participate in the research. People unable to consent to participate. Non-English speakers Exclusion criteria for GPs: A GP that cannot provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will be receiving their standard medical care. | |
| Active Comparator: Intervention<br>Participants will be receiving the intervention on top of their standard medical care. | Device: A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.<br>* A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants in the intervention arm to use during their telemedicine consultations with health care providers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short questionnaire | The questionnaire will assess use of equipment, perception of how helpful the equipment was for the consultation and the reasons why it was helpful. | 6 months (given at the end of every TM consultation) | 
| Interviews | Qualitative data collected at the end of the study according to a topic guide. | 1 day (end of study interview) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of consultations face to face | Number of face to face consultations | 6 months (every time there is a consultation) | 
| Number of consultations TM | Number of telemedicine consultations | 6 months (every time there is a consultation) | 
| Hospital admissions elective | Number of elective hospital admissions | 6 months (every time there is an admission) | 
| Hospital admissions emergency | Number of emergency hospital admissions | 6 months (every time there is an admission) | 
| Ambulance service call-outs | Number of Scottish ambulance service call-outs | 6 months (every time there is a call-out) | 
| Ambulance service paramedics | Number of face-to-face paramedic assessment | 6 months (every time there is an assessment) | 
| Survival | Survival at six months | 6 months (assessed at the end of the study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, rurality, diagnostic equipment, vulnerable patients