NCT04376736

Brief Summary

Unused clinic visits due to patient no-shows continue to plague American healthcare as a large source of waste and avoidable constraint on access. The average no-show rate across 105 studies was 23% though with wide variation (4% to 79%). No-show behavior has adverse effects on patients, providers, and healthcare organizations' operational and financial outcomes. Patients that miss clinic visits are more likely to need acute care and suffer poor health outcomes. There have been increasingly sophisticated efforts focused on predicting which patients are likely to no-show. This can allow for tactful over-booking and/or patient outreach. At Hopkins, investigators have implemented a novel machine learning based approach for identifying those patients at high-risk for no-show. Offering home visits for patients who are most likely to no-show is an appealing strategy to connect medical providers with patients who need care but are otherwise unlikely to receive it. Yet, it is unclear if this would be helpful to engage patients in their care, and encourage subsequent attendance, or if it would encourage future missed appointments, fostering a reliance on possible ongoing home visits. This study would link existing efforts with no-show prediction to home visits by internal medicine residents and evaluate its clinical impact. Patients at high-risk for no-show will be randomized into the control arm where patients will be called to remind patients of their visits. Those randomized into the intervention arm will be offered a one time home visit in lieu of their in-person visit to help understand barriers to in-person care and build rapport. Outcomes evaluated include future in-person show rates and healthcare cost/utilization

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

3.8 years

First QC Date

May 1, 2020

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Engagement

    Subsequent show up rate for medical clinic appointments, that is, number of actual visits per total number of expected visits

    1 year post enrollment

Secondary Outcomes (1)

  • Healthcare utilization as assessed by number of hospitalizations

    1 year post enrollment

Study Arms (2)

Control arm

NO INTERVENTION

Patients are reminded about their appointments

Intervention arm

EXPERIMENTAL

Patients are offered a one-time home visit by providers in lieu of their upcoming in-person visit

Other: Home visit

Interventions

Home visit by medical provider

Intervention arm

Eligibility Criteria

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

You may qualify if:

  • One or more poorly controlled chronic medical illness
  • More than one chronic illness, regardless of its level of control
  • Acute illness

You may not qualify if:

  • No documented medical illnesses (acute or chronic)
  • Single well controlled chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health CarePatient ParticipationNo-Show Patients

Interventions

House Calls

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPatient Compliance

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 6, 2020

Study Start

September 1, 2019

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations