A Pilot Study to Improve Patient-Doctor Communication
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|ClinicalTrials.gov Identifier: NCT01606930|
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : May 28, 2012
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:
- Test the feasibility of a simple patient-centered intervention.
- 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.
- Develop a coding tool that will quantify patient activation in clinical encounters.
- Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease Hypertension Hyperlipidemia Diabetes Mellitus Osteoarthritis COPD Cardiovascular Disease||Behavioral: Patient Primer Tool||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study to Improve Patient-Doctor Communication|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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
- 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.
- 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.
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
|United States, Maryland|
|Walter Reed National Medical Military Center (WRNMMC)|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Patrick O'Malley, MD, MPH||Walter Reed National Military Medical Center|