Clinical trial NCT05732922: ORCHARD- Optimising Home Assessment of Rural Patients
Official title: Optimising Remote Consulting and Home Assessment of Medically Vulnerable Rural Patients During Unscheduled and Planned Primary Care- Assessing Feasibility of the ORCHARD Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Transplant
Cancer
Inborn Errors of Metabolism
Immunosuppression
COPD Asthma
Sickle Cell Disease
Keywords: telemedicine
rurality
diagnostic equipment
vulnerable patients
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Short questionnaire
timeFrame: 6 months (given at the end of every TM consultation)
measure: Interviews
timeFrame: 1 day (end of study interview)
Secondary outcomes:
measure: Number of consultations face to face
timeFrame: 6 months (every time there is a consultation)
measure: Number of consultations TM
timeFrame: 6 months (every time there is a consultation)
measure: Hospital admissions elective
timeFrame: 6 months (every time there is an admission)
measure: Hospital admissions emergency
timeFrame: 6 months (every time there is an admission)
measure: Ambulance service call-outs
timeFrame: 6 months (every time there is a call-out)
measure: Ambulance service paramedics
timeFrame: 6 months (every time there is an assessment)
measure: Survival
timeFrame: 6 months (assessed at the end of the study)
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen
state: Aberdeen City
Study officials:
affiliation: University of Aberdeen
name: Peter Murchie
role: PRINCIPAL_INVESTIGATOR
References: