NCT03190382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

June 24, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

6.3 years

First QC Date

June 14, 2017

Last Update Submit

May 23, 2024

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict

    The primary outcome of this study will be decisional conflict as measured by the Decisional Conflict Scale.

    6 months

Study Arms (1)

Received Decision Tool

EXPERIMENTAL

Peripheral artery disease patients that received the decision support tool.

Other: Decision Support Tool

Interventions

Decision Support ToolOTHER

Patients enrolled in the study will receive the decision tool prior to the first PAD clinic visit and the medical decision making conversation with the provider.

Received Decision Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (4)

  • O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

    PMID: 7898294BACKGROUND

  • de Graaff JC, Ubbink DT, Kools EI, Chamuleau SA, Jacobs MJ. The impact of peripheral and coronary artery disease on health-related quality of life. Ann Vasc Surg. 2002 Jul;16(4):495-500. doi: 10.1007/s10016-001-0121-9. Epub 2002 Jun 27.

    PMID: 12085126BACKGROUND

  • Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011 Nov 1;58(19):2020-45. doi: 10.1016/j.jacc.2011.08.023. Epub 2011 Oct 6. No abstract available.

    PMID: 21963765BACKGROUND

  • Smolderen KG, Pacheco C, Provance J, Stone N, Fuss C, Decker C, Bunte M, Jelani QU, Safley DM, Secemsky E, Sepucha KR, Spatz ES, Mena-Hurtado C, Spertus JA. Treatment decisions for patients with peripheral artery disease and symptoms of claudication: Development process and alpha testing of the SHOW-ME PAD decision aid. Vasc Med. 2021 Jun;26(3):273-280. doi: 10.1177/1358863X20988780. Epub 2021 Feb 25.

    PMID: 33627058DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Kim G Smolderen, PhD

    University of Missouri Kansas City; Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

June 24, 2017

Primary Completion

September 30, 2023

Study Completion

April 1, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Locations

US(1)