SHOWME-PAD (Peripheral Artery Disease)
- Study HIC#:2000023411
- Last Updated:07/15/2021
Brief Summary:
The overall goal of SHOWME-PAD is to make the existing evidence-base on treatment outcomes -focusing on health status outcomes that reflect the patients' perspective - more transparently available to patients and providers, such that more informed, evidence-based shared treatment decisions occur. INTEGRITY-PAD has the potential to radically reorganize care delivery to patients with PAD such that more value for the patient and society will be created.
- Age18 years - 90 years
- GenderBoth
- Start Date01/22/2019
- End Date04/30/2018
Trial Purpose and Description
The overall goal of SHOWME-PAD is to make the existing evidence-base on treatment outcomes -focusing on health status outcomes that reflect the patients' perspective - more transparently available to patients and providers, such that more informed, evidence-based shared treatment decisions occur. INTEGRITY-PAD has the potential to radically reorganize care delivery to patients with PAD such that more value for the patient and society will be created.
Eligibility Criteria
Inclusion Criteria:
All race and ethnicity categories, English speaking, men and women
Age ≥18 years
New onset complaints of PAD symptoms or exacerbation of previous PAD symptoms
The diagnostic enrollment criterion includes a positive result for one of the following
Doppler resting ankle-brachial index (ABI)≤0.90 or a significant drop in post exercise ankle pressure of ≥20 mmHg.
Duplex
CTA
MRA
TCOM
Angiogram
Exclusion Criteria:
Non-compressible ankle-brachial index (ABI ≥ 1.30)
A lower limb revascularization procedure in the ipsilateral leg (same leg) where the patient is currently having symptoms in the past year (atherectomy, endarterectomy, bypass surgery, angioplasty)
Peripheral intervention that occurs before the baseline interview
Current episode of critical limb ischemia (ischemic rest pain, ulceration or gangrene) (Fontaine III, IV or Rutherford IV-VI)
Patients with dementia
Patients who are prisoners
Patients who are unable to provide informed consent
Non-English speaking patients