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Intervention to Increase Parent-provider Communication During Referrals (P3RC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797497
First Posted: February 22, 2013
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Oklahoma
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

The overall goal of this three-year study is to adapt and test a brief, feasible intervention using a communication tool and brief parent coaching to increase the capability of parents of children and youth with special health care needs to exchange and use medical information in partnership with their child's physicians when their children require sub-specialty referral. We hypothesize that the use of tools to coordinate referrals between physicians and parents will facilitate increased communication between primary care physicians(PCPs) and specialists, and that parents trained in information exchange and care planning will experience increased self-efficacy in interacting with their child's physicians.

There are two primary aims of the study. The first aim is to adapt a joint parent-provider referral communication and care planning intervention (i.e., the 'referral care plan') for use with ethnically diverse populations in an electronic communication environment, and optimize its usability in the practice setting. The second aim is to test the referral care plan in nine pediatric primary care and subspecialty practices in two states, using a stepped wedge cluster randomized trial, to evaluate its effect on communication, parent self-efficacy, and patient outcomes.


Condition Intervention
Parent-Provider Communication Behavioral: Care plan and coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Parent-Provider Partnerships for Referral Communication

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Patient Outcomes [ Time Frame: 3 Months ]
    The main outcome measures of the intervention will be the number of days of lost parent work time or child school time, the number of child ER visits, and the number of unplanned hospital admissions in the 3 months after the specialty visit.


Secondary Outcome Measures:
  • Parent Self-Efficacy [ Time Frame: 3 Months ]
    Self-efficacy in joint treatment planning will be assessed by administering the Perceived Efficacy in Physician-Patient Interactions (PEPPI) scale, a scale originally designed for use to evaluate older persons' self-efficacy in interacting with their physicians that has been successfully used in pediatrics.


Other Outcome Measures:
  • Information Transfer [ Time Frame: 3 Months ]
    Other outcome measures will be accurate information exchange, measured by asking parents and PCPs separately the reason for the child's referral on questionnaires, and asking parents and specialists separately the basic elements of the treatment plan (diagnosis, lab tests planned, and medications if any). A trained specialty nurse clinician reviewer will determine whether parents and physicians agree completely, if they agree partially, or if they disagree. Additionally, for patients in the intervention, parents will be asked whether they have a copy of the care plan (from the PCP) at enrollment and after the specialty visit (completed by the specialist), specialty physicians will be asked whether the care plan was available to them at the time of the consultation, and PCPs will be asked whether the completed care plan was available to them one month after the specialty visit.


Enrollment: 97
Study Start Date: March 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care plan and coaching group
In the intervention group, parents complete a referral care plan with their children's physicians and receive a brief coaching session about how to exchange information with specialists. Outcome data are collected from parents before and after the specialist visit.
Behavioral: Care plan and coaching
In the intervention group, primary care providers and parents complete their sections of the referral care plan. Parents and referred specialists receive a copy of the form. Parents receive a 5-10 minute brief intervention by phone consisting of education and coaching. The care plan is reviewed with parents to help them practice exchanging information with the specialist and encourage parents to contact their child's primary care provider with any further questions. At the specialist visit, specialists review and complete the care plan with the parent and return the plan to the referring primary care provider. Outcome data are collected from parents before and after the specialist visit.
No Intervention: Preintervention group
In the preintervention group, no care plan is used and no coaching takes place. Outcome data are collected from parents before and after the specialist visit.

Detailed Description:

One highly-promoted, evidence-based model for chronic illness service delivery for children is the Care Model for Child Health in the Medical Home. The Medical Home (MH) model has been promoted as way to improve quality while making care more efficient. Communication among members of the health care team is an essential part of the model, with sharing of care between providers preferred by families, PCPs and specialists. However, communication between referring and consulting physicians is frequently missing. Failure of communication can produce uncoordinated care, which may contribute to unmet family needs, duplication or omission of needed medical services, and medical errors.

Data on effectiveness of specific MH interventions, especially in children, are scarce. A large intervention in the MH setting was tested using written care plans and use of forms as tools to promote communication with specialists. Results indicated decreases of 40 to 70% in parent reports of lost work/school time, ER visits, and hospital admissions. Additional studies produced decreased hospitalizations and emergency room use in children.

Family-centered care (FCC), a Medical Home core component, has been conceptualized for measurement purposes as having four components: communication with health care providers, shared decision making, providing families with needed information, and self-care management and support. Interventions to improve FCC through parent-to-parent support groups and community-based support have produced increased parent confidence and problem-solving ability. Studies of asthma have shown that teaching primary care providers to take a family-centered approach to medication prescribing as part of an overall education protocol improves symptoms and decreases follow-up visits, and using a family coordinator to help physicians and parents interact more effectively is integral to improving asthma outcomes.

Shared decision-making (SDM), an element of FCC and an approach favored by family advocacy groups to help parents achieve the greatest benefits for their children with special needs, is addressed by our proposed intervention. Merely providing information to patients and families is not sufficient; families must be able to express preferences, participate in dialogue, and make informed decisions as partners with physicians.

The proposed project addresses the health care quality gaps outlined above by improving primary care-specialty-parent communication, family-centered care, and shared decision-making within the MH model. It also addresses knowledge gaps by examining the effectiveness of an important recommended component of the MH and investigating the relationship between the intervention and both process and outcome measures, in a "real-world" practice setting. If the aims of the project are achieved, we will have discovered a practical way to improve care that can be promoted to payers and policymakers.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents of children aged 0-17, AND
  • Parents of children with a chronic health condition, AND
  • Parents whose children are receiving a NEW referral to a pediatric neurologist, gastroenterologist, cardiologist, or pulmonologist

Exclusion Criteria:

  • Parents of children 18 and older
  • Parents of children without a chronic health condition
  • Parents of children who are not receiving a referral, or who are receiving a referral to a different sub-specialty
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797497


Locations
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Colorado, Denver
University of Oklahoma
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Christopher Stille, MD, MPH University of Colorado, Denver
Principal Investigator: Paul Darden, MD University of Oklahoma
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01797497     History of Changes
Other Study ID Numbers: 12-0578
1 R40MC23632-01-00 ( Other Grant/Funding Number: HRSA )
First Submitted: February 20, 2013
First Posted: February 22, 2013
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by University of Colorado, Denver:
Parents
Primary Care Providers
Specialists
Children with Special Healthcare Needs
Referral
Health Outcomes
Self-Efficacy
Communication