CONFIDENTIAL CASE REPORT FORM

1 COVID-19 CRF V3 dated 28.4.20

Participant ID

Initials of person entering data

Staff email

CONFIDENTIAL CASE REPORT FORM

COVID-19

Series 32

IMPACCT Trials Coordination Centre (ITCC)/

Palliative Care Clinical Studies Collaborative (PaCCSC)

RAPID Pharmacovigilance in Palliative Care

The case report form (CRF) is to be completed in compliance with

ITCC/PaCCSC Standard Operating Procedures (SOP)


T0 – Demographics / Co-morbidities Gender: Male Female Other Ethnic Origins

⃝ Oceanian; if yes are they: □ Aboriginal or Torres Strait Is □ Maori □ Other pacific peoples

⃝ Asian

⃝ North America

⃝ Latin American

⃝ North-West European

⃝ Southern and Eastern European

⃝ North African and Middle Eastern

⃝ Sub-Saharan African

Age (yrs)

Weight (kg) if known

Height (cm) if known

Date of first symptoms of COVID-19 – if known:

dd/mm/yyyy

Date of diagnosis of COVID-19 – if known:

dd/mm/yyyy

Was/is patient a smoker: □ Yes □ No

Charlson Comorbidity Index (tick all that apply)

□ Myocardial infarction (history, not ECG

changes only)

□ History of Hypertension

□ Congestive cardiac failure

□ Peripheral vascular disease (includes

aortic aneurysm >= 6 cm)

□ Renal disease □ Liver disease

□ Cerebrovascular disease ,CVA,

hemiplegia

□ Diabetes

□ Dementia □ Chronic pulmonary disease

□ Leukaemia (acute or chronic) □ Lymphoma

□ Any tumour without metastasis (exclude

if > 5 y from diagnosis)

□ Metastatic solid tumour

□ Connective tissue disease □ AIDS (not just HIV positive)

□ Peptic ulcer disease


T0 - Baseline Assessment

Date and time of assessment:

dd/mm/yyyy

24hr clock

Place of Care:

⃝ ICU ⃝ Acute hospital ward ⃝ Palliative Care Unit / Hospice

⃝ Emergency department ⃝ Community ⃝ RACF/nursing home ⃝ Hostel/sheltered

accommodation ⃝ Other Australian Modified Karnofsky Performance Scale (AKPS):

100 Normal; no complaints; no evidence of disease

90 Able to carry on normal activity; minor signs of symptoms

80 Normal activity with effort; some signs of symptoms or disease

70 Cares for self; unable to carry on normal activity or to do active work

60 Requires occasional assistance but is able to care for most of his needs

50 Requires considerable assistance and frequent medical care

40 In bed more than 50% of the time

30 Almost completely bedfast

20 Totally bedfast and requiring extensive nursing care by professionals and/or family

10 Comatose or barely rousable

0 Dead

Not able to determine

Most recent laboratory tests (only if available):

Test Value Date taken

D-dimer (ng/ml)

Lymphocyte count ( µL)

Lactic Dehydrogenase (LDH) (U/L)

High sensitivity C-reactive protein (hs-CRP) (mg/L)

Current Oxygen Therapy

Tick if applies

FiO2 (if applicable)

O2 saturations on current therapy

Room air/no oxygen □

O2 via nasal prongs □

O2 via Hudson mask □

02 via rebreather mask □

BiPAP/CPAP □

O2 via high flow nasal prongs □

Ventilated □


Patients Temperature: Fahrenheit □ Celsius □

T0 - Baseline Symptom Severity (Palliative Care Outcome Scale) (POS). For each symptom please tick what best describes how it has affected the patient anytime over the last 24 hours. Scoring guide: 0 = Not at all, no effect 1 = Slightly; but not bothered to be rid of the symptom 2 = Moderately; the symptom limits some activity 3 = Severely; activities or concentration markedly affected by symptom 4 = Overwhelmingly affected by symptom; unable to think of anything else

Symptom Not at all

Slightly Moderately Severely Overwhelming Unable to/not

assessed

Breathlessness 0 1 2 3 4 Respiratory secretions 0 1 2 3 4 Fever 0 1 2 3 4 Cough 0 1 2 3 4 Pain 0 1 2 3 4 Shivering 0 1 2 3 4 Sore or dry mouth/throat 0 1 2 3 4 Anxiety 0 1 2 3 4 Depression 0 1 2 3 4 Agitation 0 1 2 3 4 Confusion/Delirium 0 1 2 3 4 Drowsiness 0 1 2 3 4 Weakness/lack of energy 0 1 2 3 4 Diarrhoea 0 1 2 3 4 Constipation 0 1 2 3 4 Nausea 0 1 2 3 4 Vomiting 0 1 2 3 4 Anosmia 0 1 2 3 4 Ageusia 0 1 2 3 4 Other: 0 1 2 3 4

Other symptom 2: 0 1 2 3 4


Please specify ‘other’ symptom 1 here:




Please list medications currently being used to treat patient’s symptoms: Medication Which symptom/s are

you treating with this

medication? e.g. pain,

breathlessness,

Dose Frequency e.g. q1h,

q2h, q4h,

Route: e.g. oral,

subcutaneous,

IV, continuous infusion

Is this medication

intended as

sedation? Yes/No

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.


T1 – Subsequent assessment - 24 hours after baseline, where possible, reflecting back

on the last 12 hours


dd/mm/yyyy

24hr clock

Place of Care:


⃝ Emergency department ⃝ Community ⃝ RACF/nursing home

⃝ Hostel/sheltered accommodation ⃝ Other

Australian Modified Karnofsky Performance Scale (AKPS)











0 Dead



Tick if applies







BiPAP/CPAP □


Ventilated □



Symptom Severity (Palliative Care Outcome Scale) (POS) For each symptom please tick one box that best describes how it has affected the patient anytime over the last 12 hours. Scoring guide: 0 = Not at all, no effect 1 = Slightly; but not bothered to be rid of the symptom 2 = Moderately; the symptom limits some activity 3 = Severely; activities or concentration markedly affected by symptom 4 = Overwhelmingly affected by symptom; unable to think of anything else

Symptom Not at all

Slightly Moderately Severely Overwhelming Unable to/not

assessed








Please list medications used to treat patient’s symptoms in the last 24 hours: Medication Name Which symptom/s are


medication? e.g. pain,

breathlessness,

Dose Frequency e.g. q1h,

q2h, q4h,

or ceased

Route: e.g. oral,

subcutaneous,

IV, continuous infusion

Is this medication

intended as

sedation? Yes/No

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.


T2 – Subsequent assessment - 48 hours after baseline, where possible, reflecting back

on the last 12 hours


dd/mm/yyyy

24hr clock

Place of Care:


⃝ Emergency department ⃝ Community ⃝ RACF/nursing home

⃝ Hostel/sheltered accommodation ⃝ Other

Australian Modified Karnofsky Performance Scale (AKPS):











0 Dead



Tick if applies







BiPAP/CPAP □


Ventilated □



Symptom Severity (Palliative Care Outcome Scale) (POS) For each symptom please tick one box that best describes how it has affected the patient anytime over the last 12 hours. Scoring guide: 0 = Not at all, no effect 1 = Slightly; but not bothered to be rid of the symptom 2 = Moderately; the symptom limits some activity 3 = Severely; activities or concentration markedly affected by symptom 4 = Overwhelmingly affected by symptom; unable to think of anything else

Symptom Not at

all

Slightly Moderately Severely Overwhelming Unable

to/not assessed








Please list medications used to treat patient’s symptoms in the last 24 hours: Medication Name Which symptom/s are


medication? e.g. pain, breathlessness,

Dose Frequency

e.g. q1h,

q2h, q4h, or ceased

Route: e.g.

oral,

subcutaneous, IV, continuous

infusion

Is this

medication

intended as sedation?

Yes/No 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.


Tn - When patient dies OR there is a change in the place of care ⃝ Died – please record date and time of death

dd/mm/yyyy

24hr clock

Place of death ⃝ ICU ⃝ Acute hospital ward ⃝ Palliative Care Unit / Hospice

⃝ Emergency department ⃝ Community ⃝ RACF/nursing home ⃝ Home ⃝ Other Was patient able to have contact with family or loved ones whilst in your care?

⃝ Yes; How was contact made-(tick all that apply).

⃝ Phone

⃝ Face time/Skype/videoconferencing

⃝ In person

⃝ Other; please specify__________________________________

⃝ No: What were the barriers to this? (tick all that apply)

⃝ No access to phone

⃝ No access to Face time/Skype/videoconferencing

⃝ No visitors policy

⃝ No PPE materials

⃝ No space in ward for visitors

⃝ No time/rapid deterioration

⃝ No staff time/capacity

⃝ Other; please specify__________________________________ Any comments to add regarding either death or change in place of care: including any particularly distressing or poorly controlled symptoms in the hours leading up to death; reason for change in place of care etc.

⃝ Patient discharged

dd/mm/yyyy

⃝ Patient transferred/admitted to another place of care

dd/mm/yyyy

Documents

CONFIDENTIAL CASE REPORT FORM