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NCT Number: NCT01606930

A Pilot Study to Improve Patient-Doctor Communication

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.

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Key information

Conditions

Chronic Disease Arthritis Behavior COPD Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Disease Attributes Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Hyperlipidemia Hyperlipidemias Hypertension Joint Diseases Lipid Metabolism Disorders Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Patient Satisfaction Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Rheumatic Diseases Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Medical Military Center (WRNMMC)

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Primer Tool

Behavioral

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 names: Patient Activation Tool

Primary outcomes

  1. 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).

  2. Adherence to anti-hypertensive drug treatment at baseline

    Time frame: Baseline

    This outcome will be assessed using pill counts by the pharmacists.

  3. Adherence to anti-hypertensive drug treatment at one month

    Time frame: One month

    This outcome will be assessed using pill counts by the pharmacists.

  4. 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 outcomes

  1. Patient satisfaction

    Time frame: Baseline

    Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool

  2. Clinician rating of patient as "difficult"

    Time frame: Baseline

    Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).

  3. Patient Trust in their physician at baseline

    Time frame: Baseline

    Validated Trust in Physician (11-item) Instrument

  4. Patient Trust in their physician at one month

    Time frame: one month

    Validated Trust in Physician (11-item) Instrument

  5. Patient Trust in their physician at three months

    Time frame: Three months

    Validated Trust in Physician (11-item) Instrument

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Collaborators

  • University of Wisconsin, Milwaukee

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 28, 2012
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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