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A Pilot Study to Improve Patient-Doctor Communication

A Pilot Study to Improve Patient-Doctor Communication

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01606930
Enrollment
106
Registered
2012-05-28
Start date
2010-11-30
Completion date
2011-11-30
Last updated
2012-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Chronic Disease, COPD, Diabetes Mellitus, Hyperlipidemia, Hypertension, Osteoarthritis

Keywords

Patient Satisfaction, Patient Doctor Communication, Shared Decision Making, Patient Activation

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.

Interventions

BEHAVIORALPatient 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.

Sponsors

University of Wisconsin, Milwaukee
CollaboratorOTHER
Walter Reed National Military Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Degree of shared medical decision-makingBaselineAssessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).
Adherence to anti-hypertensive drug treatment at baselineBaselineThis outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at one monthOne monthThis outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at three monthsThree monthsThis outcome will be assessed using pill counts by the pharmacists.

Secondary

MeasureTime frameDescription
Patient Trust in their physician at three monthsThree monthsValidated Trust in Physician (11-item) Instrument
Systolic and Diastolic Blood Pressure at baselineBaselineEach blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.
Patient satisfactionBaselinePost-encounter survey using the validated Rand-9 Patient Satisfaction Tool
Systolic and Diastolic Blood Pressure at three monthsthree monthsEach blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.
Systolic and Diastolic Blood Pressure at one monthOne monthEach blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.
Clinician rating of patient as difficultBaselineClinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).
Patient Trust in their physician at baselineBaselineValidated Trust in Physician (11-item) Instrument
Patient Trust in their physician at one monthone monthValidated Trust in Physician (11-item) Instrument

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026