Increasing Caregiver and Patient Engagement Through PHR Use

Sponsor
University of Nebraska (Other)
Overall Status
Unknown status
CT.gov ID
NCT03659565
Collaborator
(none)
300
1
2
37.3
8

Study Details

Study Description

Brief Summary

Informal caregivers play an integral role in managing complex, chronic disease patients providing services equivalent to an estimated economic value of $470 billion. The inclusion of informal caregivers in the healthcare team can improve care coordination and make health care safer by reducing potential medical errors caused by miscommunication. the investigators reason that a properly designed PHR with a simplified user interface and easy access to relevant content can improve the management of chronic diseases and better integrate caregivers and patients into the healthcare team.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Enhanced Pre-Visit Consultation
  • Behavioral: Usual Care Control
N/A

Detailed Description

Informal caregivers (caregivers, often family or friends) play an integral role in managing patients with complex, chronic diseases. It is estimated that caregivers provide $470 billion of uncompensated care. Despite their impact, healthcare systems largely neglect caregivers. Long distance caregivers of older adults (who make up 15% of caregivers in America) are at a particular disadvantage. In the current healthcare system, health information technology (HIT) has not been optimized to support the needs of caregivers and patients. Providing HIT that supports enhanced communication between patients, caregivers, and clinicians can improve patient safety by increasing the accuracy of patient data and by reducing miscommunication(1).

There is limited knowledge concerning best practices to promote caregivers' and patients' activation and engagement, especially with HIT. Access to personal health information through the personal health record (PHR) has the potential to improve chronic health care management, and encourage patient engagement. Although caregivers and patients express a willingness to adopt PHRs, in practice, multiple barriers hinder PHR adoption. A properly designed PHR can help caregivers and patients manage their health and become partners in the healthcare team.

This study's overall objective is to identify caregivers and cardiovascular patients' communication and technology needs and to build and test an optimized PHR design that promotes active participation of patients and their caregivers in their health. The overall hypothesis is that an optimized PHR will expand the role of caregivers to improve the patient's health and improve the satisfaction of both patients and caregivers with their care. The investigators will employ an agile, user-centered design process involving caregivers and older cardiovascular patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Increasing Caregiver and Patient Engagement Through an Optimized Personal Health Record
Actual Study Start Date :
Apr 23, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Enhanced Pre-Visit Consultation

Patients and caregivers will participate in an enhanced pre-visit consultation using Zoom for remote video and audio conferencing with screen sharing capabilities.

Behavioral: Enhanced Pre-Visit Consultation
The Intervention Group will be given access to the optimized personal health record and will use Zoom as part of the pre-visit consultation.

Active Comparator: Usual Care Control

Patients continue to receive usual care from their cardiologist.

Behavioral: Usual Care Control
Caregivers and patients will participate in usual pre-visit process.

Outcome Measures

Primary Outcome Measures

  1. Patient activation [12 months]

    Patient activation will be measured using Altarum Consumer Engagement (ACE) Measureā„¢. The ACE survey is a 21-item survey that measures patient engagement and health consumerism.

  2. Caregiver activation [12 months]

    Caregiver activation will be measured using the Family Caregiver Activation in Transitions (FCAT) Tool. FCAT is a 10-item tool used to measure caregivers' activation and self-efficacy.

Secondary Outcome Measures

  1. Medication adherence [12 months]

    Medication adherence will be measured using the Medication Adherence Survey (MAS)

  2. Caregiver Satisfaction [12 months]

    Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) will be used to measure caregiver satisfaction. HCAHPS is a 62-item survey used to measure that will be modified to measure caregiver satisfaction.

  3. Patient Satisfaction [12 months]

    Consumer Assessment for Healthcare Providers and Systems Survey (CAHPS) will be used to measure patient satisfaction. CAHPS is a 77-item survey used to assess patients' experiences with care.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Eligible patients will be patients with heart disease, able read, write, and speak English, and at least 65 years of age.

  • Eligible caregivers will be a primary caregiver of an eligible patient, able to read, write, and speak English, and at least 18 years of age.

Exclusion Criteria:
  • Individuals under the age of 19 will not be considered for participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nebraska Medical Center Omaha Nebraska United States 68198

Sponsors and Collaborators

  • University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martina Clarke, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier:
NCT03659565
Other Study ID Numbers:
  • 491-18-EP
First Posted:
Sep 6, 2018
Last Update Posted:
Jul 9, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2020