A Pilot Study to Improve Patient-Doctor Communication

Hypertension Clinical Trial

Official title:

A Pilot Study to Improve Patient-Doctor Communication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606930
• Other study ID #: A-14352.4
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: May 23, 2012
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Disease
• COPD
• Diabetes Mellitus
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Walter Reed National Medical Military Center (WRNMMC)	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of shared medical decision-making	Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).	Baseline
Primary	Adherence to anti-hypertensive drug treatment at baseline	This outcome will be assessed using pill counts by the pharmacists.	Baseline
Primary	Adherence to anti-hypertensive drug treatment at one month	This outcome will be assessed using pill counts by the pharmacists.	One month
Primary	Adherence to anti-hypertensive drug treatment at three months	This outcome will be assessed using pill counts by the pharmacists.	Three months
Secondary	Patient satisfaction	Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool	Baseline
Secondary	Clinician rating of patient as "difficult"	Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).	Baseline
Secondary	Patient Trust in their physician at baseline	Validated Trust in Physician (11-item) Instrument	Baseline
Secondary	Patient Trust in their physician at one month	Validated Trust in Physician (11-item) Instrument	one month
Secondary	Patient Trust in their physician at three months	Validated Trust in Physician (11-item) Instrument	Three months
Secondary	Systolic and Diastolic Blood Pressure at baseline	Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.	Baseline
Secondary	Systolic and Diastolic Blood Pressure at one month	Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.	One month
Secondary	Systolic and Diastolic Blood Pressure at three months	Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.	three months