A Randomized Cross-over Clinical Trial to Evaluate the Use of Oral Health-Related Quality of Life in Dental Practice
Condition: Oral Health; Quality of Life
Study type: Interventional

Summary: 
      The aim of this study is to determine whether by incorporating an Oral Health-Related Quality
      of Life (OHRQoL) measure in dental practice will improve patient-dentist communication and
      enhance patient's satisfaction. The objectives of this study are: (i) To determine the
      measurement equivalence of Computer Touch Screen Assessment (CTSA) and Paper Based Assessment
      (PBA) of the Oral Health Impact Profile (OHIP-14). (ii) To evaluate and compare how useful a
      standardized OHRQoL assessment improves patient-dentist communication with regards to number
      of relevant OHRQoL issues addressed and percentage of most frequently items discussed between
      the intervention and control groups, assess the patient's active participation between the
      intervention and control groups and enhances patient's satisfaction between the intervention
      and control groups.
    

Detailed description: 
      The Oral Health Division of the Ministry of Health in Malaysia recognizes that customer
      centered/ patient-centered care (PCC) is of key importance in providing quality oral health
      care to the population. This paradigm shift in health care to 'patients' rather than
      'providers' in determining health needs and service outcomes requires a more holistic
      approach relying on active patient involvement. This in turn has led to the development and
      use of patient-centred health status measures - termed 'health-related quality of life'
      [HRQoL] within medicine. These HRQoL have proved effective in understanding patients' health
      needs, ability to cope with illnesses, compliance with treatment and ultimately the overall
      success of care, thus ensuring PCC. In dentistry, considerable advances have been made in
      developing valid and reliable HRQoL for oral health [OHRQoL] . The most widely used and
      sophisticated measures being the Oral health Impact Profile which has been adapted for use
      and validated in Malaysia. The challenge now is to determine how effective such a measure is
      in attaining the goal of PCC for dentistry in Malaysia.

      Method. This study id divided into two phase; phase 1 & phase 2.

      Phase 1; Testing the measurement equivalence of 'Touch-screen' versus 'Paper-based'
      assessments of OHRQoL:

        -  Study design: This study is a randomized crossover study design.

        -  Study Area: Selangor

        -  Sample and Sampling method:

             -  The participants from the residential colleges at a university campus will be
                randomly assigned through block randomization in groups of four (ABBA) into two
                arms of the trial:

                (i) Arm A where participants self-completed the CTSA followed by the PBA or (ii)
                Arm B where participants self-completed PBA followed by CTSA. Intervention (test):
                The participants answered the Oral Health Impact Profile (OHIP-14) questionnaire
                using the CTSA.

      Standard Protocol (Control): The participants answered the OHIP-14 using the PBA.

      Procedure:

        1. The participants were randomized to either (i) Arm A: completed CTSA then PBA of
           OHIP-14, or (ii) Arm B: PBA and then CTSA of OHIP-14 within the same day. User
           preference and time taken to complete the assessments were recorded. The first
           assessment was conducted in the morning (AM) session and the second assessment was
           conducted in the afternoon (PM) session. The period of 'washout' was a 'lunch period'
           between morning and afternoon sessions.

        2. Participants who able to read and speak Malay are eligible to participate in this study.

      Data Collection:

        1. All eligible participants, who fulfilled the inclusion criteria, will be invited to
           participate in this study. Assignment to trial arm was concealed in envelopes that were
           opened when informed consent was obtained from participants.

        2. PBA involved 'pen and paper' for participants to self-complete questions. Data from PBA
           were entered manually into the computer package of SPSS for the analyses.

        3. For the CTSA a Samsung tablet with Android operating system was used. The respondents
           entered their responses by touching the relevant buttons on the screen. The navigation
           buttons at the bottom of the screen allowed the screen to be moved backwards and
           forwards through the questions. The responses were compiled automatically into an excel
           file that could be accessed in Statistical Program for the Social Sciences software
           (SPSS).

        4. The formats of the questions were similar in both CTSA and PBA. The time taken for
           participants to complete PBA and CTSA was recorded by stopwatch. On completion of the
           trial participants were asked to rate their preference for PBA or CTSA (touch screen,
           paper, or no preference).

      Phase 2; To evaluate and compare how useful a standardized OHRQoL assessment improves
      patient-dentist communication :

        -  Study design: This study is a randomized crossover study design.

        -  Study Area: Selangor

        -  Sample and Sampling method:

             -  The Community Health Care Centers (CHCC) will be randomized into two groups:

      group A and B.

        -  Group A will start with intervention (test) and follow by the standard protocol
           (Control) and vice versa for group B.

      Intervention (test): Dental consultation will be carried out by incorporating an OHQoL
      assessment. The OHQoL will be measured globally using Oral Health Impact Profile (S-OHIP[M]).

      Standard Protocol (Control): Dental consultation will be carried out in a conventional way
      (without OHQoL assessment).

      Procedure:

        1. The participating dentist(s) randomized to group "A" will conduct 35 consultations
           incorporating the OHQoL assessments (i.e. the intervention) on a selected patients and
           then following a washout period of 1-month will conduct 35 consultations without OHQoL
           assessments (control). At those CHCC randomized to group 'B' participating dentist(s)
           will conduct 35 consultations without incorporating OHQoL assessments (control) and then
           following a washout period of 1-month will conduct 35 consultations with OHQoL
           assessments.

        2. Patients aged 18 and older with presenting complaint of oral pain are eligible to
           participate in this study.

      Data Collection:

        1. All eligible patients, who fulfilled the inclusion criteria, will be invited to
           participate in this study. Screening for eligibility will be done at the registration
           site. All patients in the intervention group will be asked to complete the S-OHIP[M] on
           the touch screen Samsung tablet with Android operating system prior to the consultation.
           The program will systematically summarize the results of the questionnaire.

        2. Dentists in the intervention group will perform the consultation with an addition of
           using the OHRQoL information as presented on the iPad screen in the consultation.

      Dentists in the control group, on the other hand, will perform the conventional consultation.
      The consultation will be audiotape. At the end of the treatment, patients will be given the
      satisfaction questionnaire to be completed.
    

Intervention name(s): Dental consultation using OHIP
Intervention type(s): Other
Intervention description(s): The S-OHIP[M] measure assesses the impact of one's oral health condition on QoL, contributing to 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses of each item are made on a Likert scale and coded as: 1 = never, 2 =hardly ever, 3= occasionally, 4= fairly often, and 5= very often.
Other intervention name(s): Oral Health Impact Profile (OHIP-14)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Oral Health Related Quality of Life (OHRQoL); Oral Health Impact Profile (OHIP); Dentist-Patient Relations; patients' participation.; patients' satisfaction with the consultation.