Clinical trial NCT01606930: A Pilot Study to Improve Patient-Doctor Communication
Official title: A Pilot Study to Improve Patient-Doctor Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Hypertension
Hyperlipidemia
Diabetes Mellitus
Osteoarthritis
COPD
Cardiovascular Disease
Keywords: Patient Satisfaction
Patient Doctor Communication
Shared Decision Making
Patient Activation
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: University of Wisconsin, Milwaukee
First posted: 2012-05-28
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Degree of shared medical decision-making
timeFrame: Baseline
measure: Adherence to anti-hypertensive drug treatment at baseline
timeFrame: Baseline
measure: Adherence to anti-hypertensive drug treatment at one month
timeFrame: One month
measure: Adherence to anti-hypertensive drug treatment at three months
timeFrame: Three months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Baseline
measure: Clinician rating of patient as "difficult"
timeFrame: Baseline
measure: Patient Trust in their physician at baseline
timeFrame: Baseline
measure: Patient Trust in their physician at one month
timeFrame: one month
measure: Patient Trust in their physician at three months
timeFrame: Three months
measure: Systolic and Diastolic Blood Pressure at baseline
timeFrame: Baseline
measure: Systolic and Diastolic Blood Pressure at one month
timeFrame: One month
measure: Systolic and Diastolic Blood Pressure at three months
timeFrame: three months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Medical Military Center (WRNMMC)
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Patrick O'Malley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: