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A Pilot Study to Improve Patient-Doctor Communication

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606930
First Posted: May 28, 2012
Last Update Posted: October 12, 2017
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.
Collaborator:
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
Patrick G. O'Malley, MD, MPH, Walter Reed National Military Medical Center
  Purpose

The purpose of this controlled pilot study is to determine whether an intervention aimed at patients will improve partnering, shared decision-making and open communication. Results from this pilot study will inform how to best proceed with a larger multi-centered randomized controlled trial.

The specific hypothesis for this pilot study is to:

  1. Test the feasibility of a simple patient-centered intervention.
  2. Test the correlation between patient readiness to actively engage in conversation (assessed using a pre-visit patient survey) and actual patient behaviors in the encounter.
  3. Develop a coding tool that will quantify patient activation in clinical encounters.
  4. Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.

Condition Intervention
Chronic Disease Hypertension Hyperlipidemia Diabetes Mellitus Osteoarthritis COPD Cardiovascular Disease Behavioral: Patient Primer Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Improve Patient-Doctor Communication

Further study details as provided by Patrick G. O'Malley, MD, MPH, Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Degree of shared medical decision-making [ Time Frame: Baseline ]
    Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).

  • Adherence to anti-hypertensive drug treatment at baseline [ Time Frame: Baseline ]
    This outcome will be assessed using pill counts by the pharmacists.

  • Adherence to anti-hypertensive drug treatment at one month [ Time Frame: One month ]
    This outcome will be assessed using pill counts by the pharmacists.

  • Adherence to anti-hypertensive drug treatment at three months [ Time Frame: Three months ]
    This outcome will be assessed using pill counts by the pharmacists.


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: Baseline ]
    Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool

  • Clinician rating of patient as "difficult" [ Time Frame: Baseline ]
    Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).

  • Patient Trust in their physician at baseline [ Time Frame: Baseline ]
    Validated Trust in Physician (11-item) Instrument

  • Patient Trust in their physician at one month [ Time Frame: one month ]
    Validated Trust in Physician (11-item) Instrument

  • Patient Trust in their physician at three months [ Time Frame: Three months ]
    Validated Trust in Physician (11-item) Instrument

  • Systolic and Diastolic Blood Pressure at baseline [ Time Frame: Baseline ]
    Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.

  • Systolic and Diastolic Blood Pressure at one month [ Time Frame: One month ]
    Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.

  • Systolic and Diastolic Blood Pressure at three months [ Time Frame: three months ]
    Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.


Enrollment: 106
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Group
Group will see their physician without receiving the "activation" instrument.
Active Comparator: "Activated" Group
Group will be given an "activation" instrument to complete before their appointment and instructed to refer to and use the instrument during their clinical encounter.
Behavioral: Patient Primer Tool
The instrument is completed before the scheduled appointment and is designed to prompt patients to reflect on their specific goals for the medical encounter, prioritize those goals, and to "Prime" them to engage in a discussion centered on their concerns and expectations. In addition, participants will be encouraged to bring this form into their physician visit and use it to engage their clinician in a discussion about their health needs.
Other Name: Patient Activation Tool

Detailed Description:

Chronic illness requires a greater participation by the patient in the management of their own disease process. Patients now increasingly find themselves dealing with multiple illnesses over the span of their lifetime.

Patient-provider communication is key to optimal patient outcomes. Numerous studies have shown adverse effects of poor communication on a number of outcomes, including patient and provider satisfaction as well as medical compliance and health related outcomes.

An important next step in this field is to study whether it is possible to improve chronic illness care in real world settings by improving the quality of patient-provider interaction through feasible interventions focused on efficient, motivational, and empathic communication, targeted at both patients and providers.

There is little information on the best patterns of communication in dealing with patients with multiple comorbidities. The investigators believe that an optimal healing relationship between these patients and their healthcare providers includes shared decision-making, partnering between patients and clinicians to foster health and healthy behaviors in an environment of trust, and effective open communication.

An important outcome for this pilot study is feasibility. The investigators intend to conduct a follow-up multi-centered trial; planning and budgeting for such a trial will require information gleaned from this study. What is the rate of accrual and how many patients can realistically be enrolled and followed within the current study personnel. What outcomes are sensitive to change and how much change can the investigators expect to see? Will this intervention effect change in patient behavior? This study will give us insight to allow us to build a right-sized project.

  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:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Military health care beneficiaries presenting for chronic medical care with their primary care clinician
  • Over the age of 18
  • At least 2 and no more than 10 visits with their primary care provider in the previous year
  • Receiving pharmacological treatment for hypertension
  • At least 2 of the following common chronic illnesses: hyperlipidemia, chronic obstructive pulmonary disease, asthma, congestive heart failure, chronic pain, ischemic heart disease, osteoarthritis, depression, back pain, chronic headaches, or diabetes

Exclusion Criteria:

  • Over the age of 80
  • Incapable of completing the questionnaires, either due to cognitive impairment or lack of English-literacy
  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): NCT01606930


Locations
United States, Maryland
Walter Reed National Medical Military Center (WRNMMC)
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Walter Reed National Military Medical Center
University of Wisconsin, Milwaukee
Investigators
Principal Investigator: Patrick O'Malley, MD, MPH Walter Reed National Military Medical Center
  More Information

Responsible Party: Patrick G. O'Malley, MD, MPH, Professor of Medicine, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01606930     History of Changes
Other Study ID Numbers: A-14352.4
First Submitted: April 18, 2012
First Posted: May 28, 2012
Last Update Posted: October 12, 2017
Last Verified: May 2012

Keywords provided by Patrick G. O'Malley, MD, MPH, Walter Reed National Military Medical Center:
Patient Satisfaction
Patient Doctor Communication
Shared Decision Making
Patient Activation

Additional relevant MeSH terms:
Diabetes Mellitus
Osteoarthritis
Cardiovascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Chronic Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Disease Attributes
Pathologic Processes